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CompletedNCT00321854Updated May 16, 2014Results posted

Study of (Mirapex) Pramipexole for the Early Treatment of Parkinsons Disease (PD)

A Phase 4 interventional study of pramipexole in Parkinson Disease, sponsored by Boehringer Ingelheim. Completed at 99 sites in 10 countries. Open to participants aged 30 Years to 79 Years. Per ClinicalTrials.gov, last updated 2014-05-16.

Sponsored by Boehringer Ingelheim · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
535
Allocation
Randomized
Ages
30 Years to 79 Years
Sex
All
01

Study summary

This is a double blind, placebo-controlled clinical trial of 15 months duration designed to examine early Mirapex (pramipexole) treatment vs. delayed Mirapex (pramipexole) treatment in patients with new onset Parkinsons disease

02

Conditions studied

  • Parkinson Disease

Browse trials for

03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 535 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation;
  • Male or female patient with idiopathic Parkinson Disease (PD) confirmed by at least three of the following signs: resting tremor, bradykinesia, rigidity, and asymmetry (must have bradykinesia);
  • Parkinsons disease newly diagnosed within the past 2 years;
  • Patients with idiopathic PD characterized as Stage I-II by the Modified Hoehn and Yahr Scale who do not require PD medication and will not likely need PD medication for at least 6 months in the opinion of the investigator; Age 30 to 75 years at screening (Visit 1);
  • Women of childbearing potential must have a negative serum Beta-HumanChorionGonadotropin (Beta-HCG) pregnancy test at the Screening (Baseline) visit unless surgically sterile or post-menopausal (last menstruation 12 months prior to signing Informed Consent). Women of childbearing potential must be using a medically accepted contraceptive method. Acceptable methods of birth control are limited to: Intra-Uterine Device (IUD), oral, implantable, or injectable contraceptives, estrogen patch, and double barrier method (spermicide + diaphragm); and Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion criteria

Exclusion Criteria:

  • Previous history of allergic response or complications with pramipexole (PPX) or its excipients;
  • Atypical PD syndromes due to either drugs (e.g., metoclopramide, flunarizine) or metabolic disorders (e.g., Wilsons Disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy);
  • The patient is currently on L-dopa, dopamine agonists or other PD medication at baseline;
  • The patient has been on L-dopa, dopamine agonists or other PD medications for greater than 14 consecutive days prior to baseline;
  • If on L-dopa, dopamine agonists or other PD medications prior to baseline, the patient stopped treatment less than 30 days prior to baseline;
  • The patient has clinically significant abnormal laboratory values, and/or medical or psychiatric illness other than as seen in Parkinsons disease;
  • The patient has a clinically significant deviation from normal in the physical examination other than as seen in Parkinsons disease;
  • The patient has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery);
  • History of stereotactic brain surgery;
  • Surgery within 6 months of randomization, which in the opinion of the investigator, would negatively impact the patients participation in the study;
  • History of active epilepsy (i.e., occurrence of a seizure) within the past year;
  • Symptomatic orthostatic hypotension prior to randomization;
  • Malignant melanoma or history of previously treated malignant melanoma;
  • Patients who have received any of the following drugs (all time periods are calculated from randomization): Amantadine;
  • Electroconvulsive therapy during 180 days preceding the screening visit (Visit 1);
  • Patients who are currently pregnant or planning pregnancy during the study, or lactating;
  • Participation in other investigational drug studies or use of other investigational drugs within the previous 30 days prior to randomization;
  • History of psychosis;
  • A diagnosis of dementia
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
535 participants (actual)

Study arms

  • Experimental
    Early Pramipexole

    Patients were treated with pramipexole for 6 to 9 months then up-titrated to target dose of pramipexole (2.25 mg/day).

    Drug: pramipexole

  • Experimental
    Delayed Pramipexole

    Patients were treated with placebo for 6 to 9 months then up-titrated to target dose of pramipexole (2.25 mg/day).

    Drug: pramipexole

Interventions

  • Drugpramipexole
06

What researchers measure

Primary outcomes

  1. Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15

    The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)

    Time frame: Baseline and Month 15

Secondary outcomes

  1. Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15

    The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)

    Time frame: Baseline and Month 15

  2. Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9

    The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)

    Time frame: Baseline and Month 9

  3. Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6

    The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)

    Time frame: Baseline and Month 6

  4. Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3

    The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)

    Time frame: Baseline and Month 3

  5. Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15

    The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)

    Time frame: Baseline and Month 15

  6. Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15

    The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)

    Time frame: Baseline and Month 15

  7. Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9

    The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)

    Time frame: Baseline and Month 9

  8. Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6

    The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)

    Time frame: Baseline and Month 6

  9. Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3

    The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)

    Time frame: Baseline and Month 3

  10. Change From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 15

    The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)

    Time frame: Baseline and Month 15

  11. Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 15

    The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)

    Time frame: Baseline and Month 15

  12. Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 9

    The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)

    Time frame: Baseline and Month 9

  13. Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 6

    The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)

    Time frame: Baseline and Month 6

  14. Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 3

    The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)

    Time frame: Baseline and Month 3

  15. Change From Baseline in the Blinded Rater UPDRS Part II Total Score at Month 15

    The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)

    Time frame: Baseline and Month 15

  16. Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 15

    The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)

    Time frame: Baseline and Month 15

  17. Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 9

    The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)

    Time frame: Baseline and Month 9

  18. Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 6

    The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)

    Time frame: Baseline and Month 6

  19. Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 3

    The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)

    Time frame: Baseline and Month 3

  20. Change From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15

    The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)

    Time frame: Baseline and Month 15

  21. Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15

    The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)

    Time frame: Baseline and Month 15

  22. Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9

    The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)

    Time frame: Baseline and Month 9

  23. Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6

    The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)

    Time frame: Baseline and Month 6

  24. Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3

    The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)

    Time frame: Baseline and Month 3

  25. Number of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at Month 15

    The CGI-I measures the overall improvement in the participants condition from baseline on an ordinal scale ranging from 1 (very much improved) to 7 (very much worse). Responders are defined as those patients with a CGI-I of 1 or 2.

    Time frame: Month 15

  26. Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15

    The CGI-S measures the participants severity of illness on an ordinal scale ranging from 1 (normal) to 7 (extremely ill). At Month 15 participants were categorised to 'Improved' (\>1 category improvement), 'Unchanged' or 'Worsened' (\>1 category worsening).

    Time frame: Baseline and Month 15

  27. Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15

    The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)

    Time frame: Baseline and Month 15

  28. Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 9

    The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)

    Time frame: Baseline and Month 9

  29. Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 6

    The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)

    Time frame: Baseline and Month 6

  30. Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 3

    The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)

    Time frame: Baseline and Month 3

  31. Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 15

    The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem)

    Time frame: Baseline and Month 15

  32. Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 9

    The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem)

    Time frame: Baseline and Month 9

  33. Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 15

    The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)

    Time frame: Baseline and Month 15

  34. Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 9

    The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)

    Time frame: Baseline and Month 9

  35. Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 15

    The EQ-VAS is a self rating of current health-related quality of life measured on a continuous scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)

    Time frame: Baseline and Month 15

  36. Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 9

    The EQ-VAS is a self rating of current health-related quality of life measured on a continuous scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)

    Time frame: Baseline and Month 9

  37. Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1

    The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.

    Time frame: Month 1

  38. Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6

    The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.

    Time frame: Month 6

  39. Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9

    The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.

    Time frame: Month 9

  40. Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12

    The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.

    Time frame: Month 12

  41. Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15

    The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.

    Time frame: Month 15

  42. Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1

    The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.

    Time frame: Month 1

  43. Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6

    The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.

    Time frame: Month 6

  44. Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9

    The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.

    Time frame: Month 9

  45. Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12

    The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.

    Time frame: Month 12

  46. Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15

    The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.

    Time frame: Month 15

  47. Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1

    The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.

    Time frame: Month 1

  48. Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6

    The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.

    Time frame: Month 6

  49. Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9

    The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.

    Time frame: Month 9

  50. Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12

    The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.

    Time frame: Month 12

  51. Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15

    The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.

    Time frame: Month 15

  52. Percentage Change From Baseline in the Striatum Uptake at Month 15

    The striatum beta-carbomethoxy-iodophenyl-tropane (beta-CIT) uptake was calculated as mean of the left and right caudate and putamen regions; measured by the Single-Photon Emission Computed Tomography (SPECT).

    Time frame: Baseline and Month 15

  53. Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes

    Time frame: Baseline and Month 15

  54. Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes

    Time frame: Baseline and Month 15

  55. Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates

    Time frame: Baseline and Month 15

  56. Clinically Significant Abnormalities in Vital Signs

    Time frame: Baseline and Month 15

07

Results

Posted Jan 26, 2010

Participant flow

Participant flow — Overall Study
MilestoneEarly PramipexoleDelayed Pramipexole
Started261274
Completed198192
Not completed6382
Withdrew: Adverse event4143
Withdrew: Lack of efficacy914
Withdrew: Protocol violation65
Withdrew: Lost to follow-up02
Withdrew: Withdrawal by subject617
Withdrew: Other11

Outcome measures

PrimaryChange From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15

The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)

Time frame:
Baseline and Month 15
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 150.3 ± 0.70.7 ± 0.7
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · ANCOVA · p = 0.6503 · Mean difference (net): -0.4 · 95% CI -2.2 to 1.4
SecondaryChange From Baseline in the Investigator Rated UPDRS Total Score at Month 15

The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)

Time frame:
Baseline and Month 15
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 150.6 ± 0.70.5 ± 0.7
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · ANCOVA · p = 0.9568 · Mean difference (net): 0.0 · 95% CI -1.7 to 1.8
SecondaryChange From Baseline in the Investigator Rated UPDRS Total Score at Month 9

The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)

Time frame:
Baseline and Month 9
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9-0.5 ± 0.64.3 ± 0.6
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · ANCOVA · p = <0.0001 · Mean difference (net): -4.8 · 95% CI -6.3 to -3.2
SecondaryChange From Baseline in the Investigator Rated UPDRS Total Score at Month 6

The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)

Time frame:
Baseline and Month 6
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6-1.8 ± 0.62.6 ± 0.6
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · ANCOVA · p = <0.0001 · Mean difference (net): -4.4 · 95% CI -5.8 to -3
SecondaryChange From Baseline in the Investigator Rated UPDRS Total Score at Month 3

The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)

Time frame:
Baseline and Month 3
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3-2.9 ± 0.5-0.1 ± 0.5
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · ANCOVA · p = <0.0001 · Mean difference (net): -2.9 · 95% CI -4.1 to -1.7
SecondaryChange From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15

The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)

Time frame:
Baseline and Month 15
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 150.6 ± 0.70.7 ± 0.7
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · ANCOVA · p = 0.8693 · Mean difference (net): -0.1 · 95% CI -1.8 to 1.5
SecondaryChange From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15

The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)

Time frame:
Baseline and Month 15
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 150.8 ± 0.70.6 ± 0.7
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · ANCOVA · p = 0.8155 · Mean difference (net): 0.2 · 95% CI -1.5 to 1.9
SecondaryChange From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9

The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)

Time frame:
Baseline and Month 9
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9-0.3 ± 0.64.2 ± 0.6
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · ANCOVA · p = <0.0001 · Mean difference (net): -4.5 · 95% CI -6 to -3
SecondaryChange From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6

The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)

Time frame:
Baseline and Month 6
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6-1.5 ± 0.62.5 ± 0.6
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · ANCOVA · p = <0.0001 · Mean difference (net): -4 · 95% CI -5.4 to -2.6
SecondaryChange From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3

The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)

Time frame:
Baseline and Month 3
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3-2.8 ± 0.50.0 ± 0.5
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · ANCOVA · p = <0.0001 · Mean difference (net): -2.8 · 95% CI -3.9 to -1.7
SecondaryChange From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 15

The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)

Time frame:
Baseline and Month 15
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 15
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 150.1 ± 0.50.3 ± 0.5
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · ANCOVA · p = 0.7999 · Mean difference (net): -0.2 · 95% CI -1.5 to 1.1
SecondaryChange From Baseline in the Investigator Rated UPDRS Part III Score at Month 15

The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)

Time frame:
Baseline and Month 15
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 15
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 150.2 ± 0.5-0.1 ± 0.5
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · ANCOVA · p = 0.7395 · Mean difference (net): 0.2 · 95% CI -1.1 to 1.5
SecondaryChange From Baseline in the Investigator Rated UPDRS Part III Score at Month 9

The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)

Time frame:
Baseline and Month 9
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 9
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 9-0.6 ± 0.52.7 ± 0.5
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · ANCOVA · p = <0.0001 · Mean difference (net): -3.3 · 95% CI -4.5 to -2.2
SecondaryChange From Baseline in the Investigator Rated UPDRS Part III Score at Month 6

The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)

Time frame:
Baseline and Month 6
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 6
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 6-1.6 ± 0.41.3 ± 0.4
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · ANCOVA · p = <0.0001 · Mean difference (net): -2.9 · 95% CI -4 to -1.8
SecondaryChange From Baseline in the Investigator Rated UPDRS Part III Score at Month 3

The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)

Time frame:
Baseline and Month 3
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 3
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 3-2.1 ± 0.4-0.3 ± 0.4
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · ANCOVA · p = 0.0002 · Mean difference (net): -1.8 · 95% CI -2.7 to -0.9
SecondaryChange From Baseline in the Blinded Rater UPDRS Part II Total Score at Month 15

The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)

Time frame:
Baseline and Month 15
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Blinded Rater UPDRS Part II Total Score at Month 15
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the Blinded Rater UPDRS Part II Total Score at Month 150.5 ± 0.20.4 ± 0.2
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · ANCOVA · p = 0.9256 · Mean difference (net): 0 · 95% CI -0.6 to 0.6
SecondaryChange From Baseline in the Investigator Rated UPDRS Part II Score at Month 15

The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)

Time frame:
Baseline and Month 15
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 15
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 150.6 ± 0.20.6 ± 0.2
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · ANCOVA · p = 0.9792 · Mean difference (net): 0 · 95% CI -0.6 to 0.6
SecondaryChange From Baseline in the Investigator Rated UPDRS Part II Score at Month 9

The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)

Time frame:
Baseline and Month 9
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 9
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 90.4 ± 0.21.5 ± 0.2
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · ANCOVA · p = 0.0001 · Mean difference (net): -1.1 · 95% CI -1.7 to -0.5
SecondaryChange From Baseline in the Investigator Rated UPDRS Part II Score at Month 6

The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)

Time frame:
Baseline and Month 6
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 6
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 60.1 ± 0.21.2 ± 0.2
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · ANCOVA · p = <0.0001 · Mean difference (net): -1.1 · 95% CI -1.6 to -0.6
SecondaryChange From Baseline in the Investigator Rated UPDRS Part II Score at Month 3

The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)

Time frame:
Baseline and Month 3
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 3
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 3-0.7 ± 0.20.3 ± 0.2
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · ANCOVA · p = <0.0001 · Mean difference (net): -1 · 95% CI -1.5 to -0.6
SecondaryChange From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15

The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)

Time frame:
Baseline and Month 15
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15-0.3 ± 0.10 ± 0.1
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · ANCOVA · p = 0.0376 · Mean difference (net): -0.3 · 95% CI -0.5 to 0
SecondaryChange From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15

The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)

Time frame:
Baseline and Month 15
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15-0.2 ± 0.1-0.1 ± 0.1
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · ANCOVA · p = 0.1607 · Mean difference (net): -0.2 · 95% CI -0.4 to 0.1
SecondaryChange From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9

The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)

Time frame:
Baseline and Month 9
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9-0.2 ± 0.10.1 ± 0.1
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · ANCOVA · p = 0.0173 · Mean difference (net): -0.3 · 95% CI -0.5 to -0.1
SecondaryChange From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6

The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)

Time frame:
Baseline and Month 6
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6-0.3 ± 0.10.1 ± 0.1
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · ANCOVA · p = 0.0007 · Mean difference (net): -0.4 · 95% CI -0.6 to -0.2
SecondaryChange From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3

The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)

Time frame:
Baseline and Month 3
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3-0.2 ± 0.1-0.1 ± 0.1
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · ANCOVA · p = 0.4381 · Mean difference (net): -0.1 · 95% CI -0.3 to 0.1
SecondaryNumber of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at Month 15

The CGI-I measures the overall improvement in the participants condition from baseline on an ordinal scale ranging from 1 (very much improved) to 7 (very much worse). Responders are defined as those patients with a CGI-I of 1 or 2.

Time frame:
Month 15
Reported as:
Number · Participants
Number of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at Month 15
ParticipantsEarly PramipexoleDelayed Pramipexole
Number of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at Month 151821
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · Regression, Logistic · p = 0.5116 · Odds ratio (or): 0.796 · 95% CI 0.403 to 1.573
SecondaryChange From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15

The CGI-S measures the participants severity of illness on an ordinal scale ranging from 1 (normal) to 7 (extremely ill). At Month 15 participants were categorised to 'Improved' (\>1 category improvement), 'Unchanged' or 'Worsened' (\>1 category worsening).

Time frame:
Baseline and Month 15
Reported as:
Number · Participants
Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15
ParticipantsEarly PramipexoleDelayed Pramipexole
Improved43
Essentially unchanged200191
Worsened54
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · Regression, Logistic · p = 0.7913 · Odds ratio (or): 1.153 · 95% CI 0.403 to 3.299
SecondaryChange From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15

The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)

Time frame:
Baseline and Month 15
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15-1 ± 0.3-0.5 ± 0.3
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · ANCOVA · p = 0.1702 · Mean difference (net): -0.5 · 95% CI -1.3 to 0.2
SecondaryChange From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 9

The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)

Time frame:
Baseline and Month 9
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 9
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 9-1.1 ± 0.30.3 ± 0.3
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · ANCOVA · p = 0.0009 · Mean difference (net): -1.4 · 95% CI -2.2 to -0.6
SecondaryChange From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 6

The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)

Time frame:
Baseline and Month 6
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 6
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 6-1.2 ± 0.30.2 ± 0.3
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · ANCOVA · p = 0.0005 · Mean difference (net): -1.4 · 95% CI -2.1 to -0.6
SecondaryChange From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 3

The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)

Time frame:
Baseline and Month 3
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 3
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 3-1 ± 0.3-0.3 ± 0.3
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · ANCOVA · p = 0.0422 · Mean difference (net): -0.7 · 95% CI -1.4 to 0
SecondaryChange From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 15

The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem)

Time frame:
Baseline and Month 15
Reported as:
Median · Units on a scale
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 15
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 15-0.4 ± -0.40.3 ± 0.3
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · Wilcoxon (Mann-Whitney) · p = 0.2149 · Median difference (net): -0.573 · 95% CI -1.823 to 0.677
SecondaryChange From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 9

The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem)

Time frame:
Baseline and Month 9
Reported as:
Median · Units on a scale
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 9
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 9-0.5 ± -0.51.4 ± 1.4
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · Wilcoxon (Mann-Whitney) · p = 0.0001 · Median difference (net): -2.031 · 95% CI -3.125 to -0.938
SecondaryChange From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 15

The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)

Time frame:
Baseline and Month 15
Reported as:
Median · Units on a scale
Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 15
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 150 ± 00 ± 0
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · Wilcoxon (Mann-Whitney) · p = 0.2605 · Median difference (net): 0 · 95% CI 0 to 0.026
SecondaryChange From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 9

The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)

Time frame:
Baseline and Month 9
Reported as:
Median · Units on a scale
Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 9
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 90 ± 00 ± 0
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · Wilcoxon (Mann-Whitney) · p = <0.0001 · Median difference (net): 0.051 · 95% CI 0 to 0.089
SecondaryChange From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 15

The EQ-VAS is a self rating of current health-related quality of life measured on a continuous scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)

Time frame:
Baseline and Month 15
Reported as:
Median · Units on a scale
Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 15
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 150 ± 00 ± 0
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · Wilcoxon (Mann-Whitney) · p = 0.0489 · Median difference (net): 2 · 95% CI 0 to 5
SecondaryChange From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 9

The EQ-VAS is a self rating of current health-related quality of life measured on a continuous scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)

Time frame:
Baseline and Month 9
Reported as:
Median · Units on a scale
Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 9
Units on a scaleEarly PramipexoleDelayed Pramipexole
Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 90 ± 0-0.5 ± -0.5
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · Wilcoxon (Mann-Whitney) · p = 0.0282 · Median difference (net): 3 · 95% CI 0 to 5
SecondaryModified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1

The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.

Time frame:
Month 1
Reported as:
Number · Participants
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1
ParticipantsEarly PramipexoleDelayed Pramipexole
No risk of gambling146133
Risk of gambling00
SecondaryModified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6

The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.

Time frame:
Month 6
Reported as:
Number · Participants
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6
ParticipantsEarly PramipexoleDelayed Pramipexole
No risk of gambling146134
Risk of gambling00
SecondaryModified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9

The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.

Time frame:
Month 9
Reported as:
Number · Participants
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9
ParticipantsEarly PramipexoleDelayed Pramipexole
No risk of gambling146134
Risk of gambling00
SecondaryModified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12

The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.

Time frame:
Month 12
Reported as:
Number · Participants
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12
ParticipantsEarly PramipexoleDelayed Pramipexole
No risk of gambling143128
Risk of gambling00
SecondaryModified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15

The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.

Time frame:
Month 15
Reported as:
Number · Participants
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15
ParticipantsEarly PramipexoleDelayed Pramipexole
No risk of gambling145132
Risk of gambling00
SecondaryModified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1

The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.

Time frame:
Month 1
Reported as:
Number · Participants
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1
ParticipantsEarly PramipexoleDelayed Pramipexole
No compulsive sexual behaviour146133
Compulsive sexual behaviour00
SecondaryModified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6

The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.

Time frame:
Month 6
Reported as:
Number · Participants
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6
ParticipantsEarly PramipexoleDelayed Pramipexole
No compulsive sexual behaviour146134
Compulsive sexual behaviour00
SecondaryModified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9

The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.

Time frame:
Month 9
Reported as:
Number · Participants
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9
ParticipantsEarly PramipexoleDelayed Pramipexole
No compulsive sexual behaviour146134
Compulsive sexual behaviour00
SecondaryModified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12

The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.

Time frame:
Month 12
Reported as:
Number · Participants
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12
ParticipantsEarly PramipexoleDelayed Pramipexole
No compulsive sexual behaviour143126
Compulsive sexual behaviour02
SecondaryModified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15

The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.

Time frame:
Month 15
Reported as:
Number · Participants
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15
ParticipantsEarly PramipexoleDelayed Pramipexole
No compulsive sexual behaviour145131
Compulsive sexual behaviour01
SecondaryModified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1

The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.

Time frame:
Month 1
Reported as:
Number · Participants
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1
ParticipantsEarly PramipexoleDelayed Pramipexole
No compulsive buying145133
Compulsive buying10
SecondaryModified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6

The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.

Time frame:
Month 6
Reported as:
Number · Participants
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6
ParticipantsEarly PramipexoleDelayed Pramipexole
No compulsive buying144134
Compulsive buying20
SecondaryModified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9

The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.

Time frame:
Month 9
Reported as:
Number · Participants
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9
ParticipantsEarly PramipexoleDelayed Pramipexole
No compulsive buying143134
Compulsive buying30
SecondaryModified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12

The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.

Time frame:
Month 12
Reported as:
Number · Participants
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12
ParticipantsEarly PramipexoleDelayed Pramipexole
No compulsive buying141128
Compulsive buying20
SecondaryModified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15

The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.

Time frame:
Month 15
Reported as:
Number · Participants
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15
ParticipantsEarly PramipexoleDelayed Pramipexole
No compulsive buying143132
Compulsive buying20
SecondaryPercentage Change From Baseline in the Striatum Uptake at Month 15

The striatum beta-carbomethoxy-iodophenyl-tropane (beta-CIT) uptake was calculated as mean of the left and right caudate and putamen regions; measured by the Single-Photon Emission Computed Tomography (SPECT).

Time frame:
Baseline and Month 15
Reported as:
Least squares mean · Percentage change
Percentage Change From Baseline in the Striatum Uptake at Month 15
Percentage changeEarly PramipexoleDelayed Pramipexole
Percentage Change From Baseline in the Striatum Uptake at Month 15-15.1 ± 2.1-14.6 ± 2
Statistical analysis
  • Early Pramipexole vs Delayed Pramipexole · ANCOVA · p = 0.8397 · Mean difference (net): -0.5 · 95% CI -5.4 to 4.4
SecondaryClinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes
Time frame:
Baseline and Month 15
Reported as:
Number · percentage of participants
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes
percentage of participantsEarly PramipexoleDelayed Pramipexole
Haematocrit - decrease1.41.0
Haemoglobin - decrease2.30.9
MCV - increase0.50
Sodium - decrease1.40.5
Calcium - increase00.5
Chloride - decrease0.90
Phosphate - decrease1.00
Phosphate - increase0.50
SecondaryClinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes
Time frame:
Baseline and Month 15
Reported as:
Number · percentage of participants
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes
percentage of participantsEarly PramipexoleDelayed Pramipexole
GGT - increase0.50
Amylase - increase1.40
SecondaryClinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates
Time frame:
Baseline and Month 15
Reported as:
Number · percentage of participants
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates
percentage of participantsEarly PramipexoleDelayed Pramipexole
Glucose - decrease02.2
Glucose - increase3.60
Cholesterol - increase1.42.9
Blood Urea Nitrogen - increase0.90.5
Creatinine - increase0.51.0
Triglyceride - increase1.40
Uric acid - increase0.50.5
SecondaryClinically Significant Abnormalities in Vital Signs
Time frame:
Baseline and Month 15
Reported as:
Number · percentage of participants
Clinically Significant Abnormalities in Vital Signs
percentage of participantsEarly PramipexoleDelayed Pramipexole
Sinus bradycardia00.4
Hypotension00.5

Adverse events

Collected over Onset date after the date of first dose up to 48 hours after last dose of study drug.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Early Pramipexole—25/261 (9.6%)172/261 (65.9%)
Delayed Pramipexole—25/274 (9.1%)164/274 (59.9%)
Most frequent serious events
Showing 10 of 66
Most frequent serious events
EventEarly PramipexoleDelayed Pramipexole
HallucinationPsychiatric disorders2/2610/274
Transient ischaemic attackNervous system disorders2/2611/274
Urinary tract infectionInfections and infestations0/2612/274
Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/2612/274
Bacterial infectionInfections and infestations1/2610/274
GastroenteristisInfections and infestations1/2610/274
InfluenzaInfections and infestations1/2610/274
Localised infectionInfections and infestations1/2610/274
Large cell carcinoma of the respiratory tract stage unspecifiedNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/2610/274
Lung neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/2610/274
Most frequent other events
Showing 10 of 16
Most frequent other events
EventEarly PramipexoleDelayed Pramipexole
NauseaGastrointestinal disorders62/26149/274
FatigueGeneral disorders36/26138/274
SomnolenceNervous system disorders36/26121/274
DizzinessNervous system disorders35/26133/274
HeadacheNervous system disorders20/26128/274
ConstipationGastrointestinal disorders19/26128/274
InsomniaPsychiatric disorders26/26121/274
Oedema peripheralGeneral disorders25/26113/274
Back painMusculoskeletal and connective tissue disorders24/26118/274
NasopharyngitisInfections and infestations19/26124/274

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Early PramipexoleDelayed PramipexoleTotal
Mean62.1 ± 10.162.9 ± 9.962.5 ± 10
Sex: Female, Male
Sex: Female, Male(Participants)Early PramipexoleDelayed PramipexoleTotal
Female84108192
Male177166343
08

Study locations

99 sites
  • 248.595.0122 Boehringer Ingelheim Investigational Site
    Brimingham, Alabama, United States
  • 248.595.0104 Boehringer Ingelheim Investigational Site
    Scottsdale, Arizona, United States
  • 248.595.0133 Boehringer Ingelheim Investigational Site
    La Jolla, California, United States
  • 248.595.0140 Boehringer Ingelheim Investigational Site
    La Jolla, California, United States
  • 248.595.0112 Boehringer Ingelheim Investigational Site
    New Haven, Connecticut, United States
  • 248.595.0113 Boehringer Ingelheim Investigational Site
    Bradenton, Florida, United States
  • 248.595.0105 Boehringer Ingelheim Investigational Site
    Gainesville, Florida, United States
  • 248.595.0119 Boehringer Ingelheim Investigational Site
    Hollywood, Florida, United States
  • 248.595.0124 Boehringer Ingelheim Investigational Site
    Palm Beach Gardens, Florida, United States
  • 248.595.0123 Boehringer Ingelheim Investigational Site
    Panama City, Florida, United States
  • 248.595.0109 Boehringer Ingelheim Investigational Site
    South Miami, Florida, United States
  • 248.595.0115 Boehringer Ingelheim Investigational Site
    St. Petersburg, Florida, United States
  • 248.595.0106 Boehringer Ingelheim Investigational Site
    Tampa, Florida, United States
  • 248.595.0103 Boehringer Ingelheim Investigational Site
    Atlanta, Georgia, United States
  • 248.595.0127 Boehringer Ingelheim Investigational Site
    Augusta, Georgia, United States
  • 248.595.0137 Boehringer Ingelheim Investigational Site
    Columbus, Georgia, United States
  • 248.595.0101 Boehringer Ingelheim Investigational Site
    Chicago, Illinois, United States
  • 248.595.0111 Boehringer Ingelheim Investigational Site
    Elk Grove Village, Illinois, United States
  • 248.595.0131 Boehringer Ingelheim Investigational Site
    Scarbourough, Maine, United States
  • 248.595.0134 Boehringer Ingelheim Investigational Site
    Baltimore, Maryland, United States
  • 248.595.0141 Boehringer Ingelheim Investigational Site
    Worcester, Massachusetts, United States
  • 248.595.0102 Boehringer Ingelheim Investigational Site
    Traverse City, Michigan, United States
  • 248.595.0129 Boehringer Ingelheim Investigational Site
    New York, New York, United States
  • 248.595.0139 Boehringer Ingelheim Investigational Site
    Raleigh, North Carolina, United States
  • 248.595.0136 Boehringer Ingelheim Investigational Site
    Winston Salem, North Carolina, United States
  • 248.595.0120 Boehringer Ingelheim Investigational Site
    Cleveland, Ohio, United States
  • 248.595.0107 Boehringer Ingelheim Investigational Site
    Dayton, Ohio, United States
  • 248.595.0118 Boehringer Ingelheim Investigational Site
    Tulsa, Oklahoma, United States
  • 248.595.0114 Boehringer Ingelheim Investigational Site
    Warwick, Rhode Island, United States
  • 248.595.0116 Boehringer Ingelheim Investigational Site
    Memphis, Tennessee, United States
  • 248.595.0108 Boehringer Ingelheim Investigational Site
    Houston, Texas, United States
  • 248.595.0121 Boehringer Ingelheim Investigational Site
    Kirkland, Washington, United States
  • 248.595.43005 Boehringer Ingelheim Investigational Site
    Bruck a. d. Mur, Austria
  • 248.595.43003 Boehringer Ingelheim Investigational Site
    Graz, Austria
  • 248.595.43001 Boehringer Ingelheim Investigational Site
    Innsbruck, Austria
  • 248.595.43002 Boehringer Ingelheim Investigational Site
    Wien, Austria
  • 248.595.43004 Boehringer Ingelheim Investigational Site
    Wien, Austria
  • 248.595.35803 Boehringer Ingelheim Investigational Site
    Helsinki, Finland
  • 248.595.35804 Boehringer Ingelheim Investigational Site
    Lahti, Finland
  • 248.595.35801 Boehringer Ingelheim Investigational Site
    Oulu, Finland
  • 248.595.3306A Centre Hospitalier du Pays d'Aix
    Aix en Provence, France
  • 248.595.3306B Centre Hospitalier du Pays d'Aix
    Aix en Provence, France
  • 248.595.3306C Centre Hospitalier du Pays d'Aix
    Aix en Provence, France
  • 248.595.3301A Hôpital Gabriel Montpied
    Clermont Ferrand, France
  • 248.595.3301B Hôpital Gabriel Montpied
    Clermont Ferrand, France
  • 248.595.3303A Cabinet Médical
    Evreux, France
  • 248.595.3307A Hôpital Roger Salengro
    Lille cedex, France
  • 248.595.3307B Hôpital Roger Salengro
    Lille cedex, France
  • 248.595.3302A Hôpital La Timone
    Marseille cedex 05, France
  • 248.595.3302B Hôpital La Timone
    Marseille cedex 05, France
  • 248.595.3305A Hôpital Purpan
    Toulouse cedex 9, France
  • 248.595.3305C Hôpital Purpan
    Toulouse cedex 9, France
  • 248.595.49006 Boehringer Ingelheim Investigational Site
    Augsburg, Germany
  • 248.595.49008 Boehringer Ingelheim Investigational Site
    Berlin, Germany
  • 248.595.49007 Boehringer Ingelheim Investigational Site
    Bochum, Germany
  • 248.595.49011 Boehringer Ingelheim Investigational Site
    Bonn, Germany
  • 248.595.49016 Boehringer Ingelheim Investigational Site
    Gera, Germany
  • 248.595.49009 Boehringer Ingelheim Investigational Site
    Göttingen, Germany
  • 248.595.49004 Boehringer Ingelheim Investigational Site
    Hamburg, Germany
  • 248.595.49010 Boehringer Ingelheim Investigational Site
    Hanau, Germany
  • 248.595.49005 Boehringer Ingelheim Investigational Site
    Hannover, Germany
  • 248.595.49012 Boehringer Ingelheim Investigational Site
    Leipzig, Germany
  • 248.595.49001 Boehringer Ingelheim Investigational Site
    Marburg, Germany
  • 248.595.49015 Boehringer Ingelheim Investigational Site
    München, Germany
  • 248.595.49014 Boehringer Ingelheim Investigational Site
    Tübingen, Germany
  • 248.595.39004 Università degli Studi di Bari
    Bari, Italy
  • 248.595.39009 Ospedale di Bellaria
    Bologna, Italy
  • 248.595.39005 Ospedale della Misericordia
    Grosseto, Italy
  • 248.595.39001 Azienda Ospedaliera Istituti Clinici di Perfezionamento
    Milano, Italy
  • 248.595.39010 Ospedale Maggiore Policlinico Mangigalli e Regina Elena
    Milano, Italy
  • 248.595.39011 Ospedale S. Raffaele - IRCCS
    Milano, Italy
  • 248.595.39002 Università Federico II
    Napoli, Italy
  • 248.595.39012 Azienda Ospedaliera Pisana- Università degli Studi di Pisa
    Pisa, Italy
  • 248.595.39014 Boehringer Ingelheim Investigational Site
    Roma, Italy
  • 248.595.39006 Policlinico Universitario Molinette
    Torino, Italy
  • 248.595.39007 Ospedale Evangelico Valdese
    Torino, Italy
  • 248.595.39013 Ospedale Umberto I
    Venezia Mestre, Italy
  • 248.595.39003 Ospedale di Viareggio
    Viareggio, Italy
  • 248.595.81001 Juntendo University Hospital
    Bunkyo-ku, Tokyo, Japan
  • 248.595.81002 Kagawa Prefectural Central Hospital
    Takamatsu, Kagawa, Japan
  • 248.595.34003 Hospital de Alcorcon
    Alcorcon (Madrid), Spain
  • 248.595.34001 Hospital Clinic i Provincial of Barcelona
    Barcelona, Spain
  • 248.595.34002 Nuevo Hospital de Sant Pau
    Barcelona, Spain
  • 248.595.34004 Hospital 12 de Octubre
    Madrid, Spain
  • 248.595.34005 Hospital Mutua de Terrassa
    Tarrasa (Barcelona), Spain
  • 248.595.46004 Boehringer Ingelheim Investigational Site
    Jönköping, Sweden
  • 248.595.46006 Boehringer Ingelheim Investigational Site
    Linköping, Sweden
  • 248.595.46005 Boehringer Ingelheim Investigational Site
    Norrköping, Sweden
  • 248.595.46001 Boehringer Ingelheim Investigational Site
    Stockholm, Sweden
  • 248.595.46007 Boehringer Ingelheim Investigational Site
    Stockholm, Sweden
  • 248.595.46002 Boehringer Ingelheim Investigational Site
    Örebro, Sweden
  • 248.595.44003 Boehringer Ingelheim Investigational Site
    Birmingham, United Kingdom
  • 248.595.44008 Boehringer Ingelheim Investigational Site
    Glasgow, United Kingdom
  • 248.595.44004 Boehringer Ingelheim Investigational Site
    London, United Kingdom
  • 248.595.44002 Boehringer Ingelheim Investigational Site
    Newark, United Kingdom
  • 248.595.44001 Boehringer Ingelheim Investigational Site
    Newcastle upon Tyne, United Kingdom
  • 248.595.44010 Boehringer Ingelheim Investigational Site
    North Shields, United Kingdom
  • 248.595.44011 Boehringer Ingelheim Investigational Site
    Romford, United Kingdom
  • 248.595.44005 Boehringer Ingelheim Investigational Site
    Stoke-on-Trent, United Kingdom
09

References and documents

Publications

  • Schapira AH, McDermott MP, Barone P, Comella CL, Albrecht S, Hsu HH, Massey DH, Mizuno Y, Poewe W, Rascol O, Marek K. Pramipexole in patients with early Parkinson's disease (PROUD): a randomised delayed-start trial. Lancet Neurol. 2013 Aug;12(8):747-55. doi: 10.1016/S1474-4422(13)70117-0. Epub 2013 May 31. PubMed 23726851 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00321854
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
May 4, 2006
Start date
May 2006
Primary completion
Apr 2009
Results posted
Jan 26, 2010
Last update
May 16, 2014

Study contacts

Boehringer Ingelheim
study chair · Boehringer Ingelheim
View the source record on ClinicalTrials.gov ↗

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