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CompletedNCT00577460Updated May 16, 2014Results posted

Long-term Safety Study of Open-label Pramipexole ER in Patients With Advanced PD

A Phase 3 interventional study of Pramipexole and Placebo in Parkinson Disease, sponsored by Boehringer Ingelheim. Completed at 70 sites in 14 countries. Open to participants aged 32 Years and older. Per ClinicalTrials.gov, last updated 2014-05-16.

Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
391
Allocation
Non-randomized
Ages
32 Years and older
Sex
All
01

Study summary

The general aim of this study is to obtain long-term safety and tolerability data on pramipexole extended release (ER), in daily doses from 0.375mg to 4.5mg once daily (qd), in patients who have previously completed a pramipexole double-blind study in advanced Parkinson's disease (PD) (248.525 trial).

02

Conditions studied

  • Parkinson Disease

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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 391 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
32 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Completion of the double-blind trial 248.525
  2. Male or female patient with advanced idiopathic Parkinson's disease (PD), with a Modified Hoehn and Yahr stage of 2 to 4 at on-time, and a concomitant treatment with standard or controlled release L-Dopa+, or a combination of L-Dopa+ and entacapone.
  3. Patient willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. In particular the patient should be able to recognise the off-time and on-time periods during waking hours and the patient (or a family member or a guardian) should be able to record them accurately in the patient diary.
  4. Signed informed consent obtained before any study procedures are carried out (in accordance with International Conference of Harmonization - Good Clinical Practice (ICH-GCP) guidelines and local legislation).

Exclusion criteria

Exclusion criteria:

  1. Patients prematurely withdrawn from the double-blind trial 248.525
  2. Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases
  3. Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria that could prevent compliance or completion of the study and/or put the patient at risk if he/she takes part in the study
  4. History of psychosis, except history of drug induced hallucinations
  5. History of deep brain stimulation
  6. Clinically significant ECG abnormalities at baseline
  7. Clinically significant hypotension and/or symptomatic orthostatic hypotension at baseline
  8. Malignant melanoma or history of previously treated malignant melanoma
  9. Any other clinically significant disease, whether treated or not, that could put the patient at risk or could prevent compliance or completion of the study
  10. Pregnancy or breast-feeding
  11. Sexually active female of childbearing potential not using a medically approved method of birth control
  12. Serum levels of aspartate transaminase (AST) (serum glutamic oxaloacetic transaminase (SGOT)), alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase) (SGPT)), alkaline phosphatase (AP) or bilirubin > 2 upper limit normal (ULN) at baseline
  13. Patients with a creatinine clearance \< 50 mL/min at baseline
  14. Any medication with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit
  15. Any of the following drugs within 4 weeks prior to baseline visit: methylphenidate, cinnarizine, amphetamines
  16. Flunarizine within 3 months prior to baseline
  17. Known hypersensitivity to pramipexole or its excipients
  18. Drug abuse, according to investigators judgement, within 2 years prior to baseline
  19. Participation in investigational drug studies other than the trial 248.525, or use of other investigational drugs within one month or five times the half-life of the investigational drug (whichever is longer) prior to baseline
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
391 participants (actual)

Study arms

  • Active comparator
    Pramipexole

    Patients to receive Pramipexole ER 0.375 - 4.5 mg in tablet form daily

    Drug: Pramipexole

  • Placebo comparator
    Placebo

    Patients to receive placebo tablets identical to Pramipexole ER tablets only during transfer phase

    Drug: Placebo

Interventions

  • DrugPramipexole

    Pramipexole ER 0.375 -4.5 mg

  • DrugPlacebo

    Placebo tablets identical to Pramipexole ER tablets

06

What researchers measure

Primary outcomes

  1. Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events

    The aim of this study was to obtain long-term safety and tolerability data on pramipexole ER, in patients who have previously completed a pramipexole double blind study in advanced Parkinson's Disease (PD) (248.525 (NCT00466167)). Therefore these items were considered as a safety evaluation.

    Time frame: 80 weeks

Secondary outcomes

  1. Patients Successfully Switched From Pramipexole (PPX) IR or ER to ER Assessed on UPDRS II+III

    Unified Parkinson's Disease Rating Scale (UPDRS) Successfully switched means: UPDRS II+III baseline score \>20 without a relative worsening of UPDRS II+III score \> 15% from baseline or UPDRS II+III baseline score \<=20 without an absolute worsening of UPDRS II+III score \> 3 from baseline UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms

    Time frame: One week

  2. UPDRS II+III Change From Open Label (OL) Baseline

    UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms

    Time frame: OL Baseline and week 80

  3. Number of Participants With UPDRS II+III Response

    A response means an improvement of \>=20% in UPDRS II+III from OL baseline UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms

    Time frame: Week 80

  4. Number of Patients Successfully Switched From PPX IR or ER to ER Assessed on Off-time

    A patient was considered as successfully switched if he/she has converted to ER without a worsening of off time by more than 12.5% from baseline. Off-time is based on patient diary data and describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).

    Time frame: One week

  5. Percentage Off Time During Waking Hours Total Score: Change From Baseline

    Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). A negative change implies improvement

    Time frame: Baseline and week 80

  6. Number of Participants With Response in Percentage Off Time During Waking Hours

    Response means \>=20% improvement relative to OL baseline in the % off-time during waking hours

    Time frame: 80 weeks

  7. Percentage on Time Without Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks

    Percentage on-time based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement.

    Time frame: Baseline and week 80

  8. Percentage on Time With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks

    Percentage on-time with non troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement

    Time frame: Baseline and week 80

  9. Percentage on Time Without Dyskinesia or With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks

    Percentage on-time without dyskinesia or with non troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement

    Time frame: Baseline and week 80

  10. Percentage on Time With Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks

    Percentage on-time with troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement

    Time frame: Baseline and week 80

  11. Number of Participants With Response in CGI-I

    Clinical Global Impression of Improvement (CGI-I), CGI-I scores ranging from '1' (very much improved) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least "much improved" were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much improved were considered as responders

    Time frame: 32 weeks

  12. Number of Participants With Response in PGI-I

    Patient Global Impression of Improvement (PGI-I), PGI-I scores ranging from '1' (very much better) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least "much better" were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much better were considered as responders

    Time frame: 32 weeks

  13. Number of Participants With Response in PGI-I for Early Morning Off Symptoms

    Patient Global Impression of Improvement (PGI-I) for early morning off symptoms, PGI-I scores ranging from '1' (very much better) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least "much better" were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much better were considered as responders

    Time frame: 32 weeks

  14. UPDRS I Total Score and Change From OL Baseline at Week 80

    UPDRS I ranging from 0 (normal) to 16 (severe). UPDRS I measures Mentation, Behavior and Mood

    Time frame: OL baseline and week 80

  15. UPDRS II Total Score and Change From OL Baseline at Week 80

    UPDRS II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS part II at on and UPDRS part II at off-period for each of the 13 activities

    Time frame: OL baseline and week 80

  16. UPDRS III Total Score and Change From OL Baseline at Week 80

    UPDRS III ranging from 0 (normal) to 108 (severe). UPDRS part III measures motor symptoms

    Time frame: OL baseline and week 80

  17. UPDRS IV Total Score and Change From OL Baseline at Week 80

    UPDRS IV ranging from 0 (normal) to 23 (severe). UPDRS IV measures complications of therapy

    Time frame: OL baseline and week 80

  18. Parkinson Fatigue Scale (PFS-16) Score and Change From OL Baseline at Week 80

    PFS-16 (Parkinson fatigue scale) ranging from 16 (better perceived health status) to 80 (severe symptoms of the disease) measuring aspects of fatigue that are relevant to patients with PD

    Time frame: OL baseline and week 80

  19. Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80

    Time frame: OL baseline and week 80

  20. Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline

    Time frame: OL baseline and week 80

  21. Number of Participants With Serious Adverse Events

    Time frame: 80 weeks

  22. Supine Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set

    Time frame: OL Baseline and Week 80

  23. Standing Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set

    Time frame: OL Baseline and Week 80

  24. Supine Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set

    Time frame: OL Baseline and Week 80

  25. Standing Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set

    Time frame: OL Baseline and Week 80

  26. Supine Pulse Rate, Baseline and Week 80, Vital Signs Treated Set

    Time frame: OL Baseline and Week 80

  27. Standing Pulse Rate, Baseline and Week 80, Vital Signs Treated Set

    Time frame: OL Baseline and Week 80

  28. Body Weight of Female Patients, Baseline and Week 80, Vital Signs Treated Set

    Time frame: OL Baseline and Week 80

  29. Body Weight of Male Patients, Baseline and Week 80, Vital Signs Treated Set

    Time frame: OL Baseline and Week 80

  30. Epworth Sleepiness Scale (ESS), Baseline and End of Open Label, Treated Set

    ESS Total score ranges from zero (best) to 24 (worst); scale has 8 items, each rated from zero (no chance of dozing) to 3 (high chance of dozing)

    Time frame: OL Baseline and Week 80

  31. Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set

    The mMIDI is a semi-structured interview designed to assess impulsive control disorders. The scale was modified to focus behaviors of: pathological gambling, compulsive buying and compulsive sexual behavioral.

    Time frame: Baseline, 80 weeks

07

Results

Posted Jul 14, 2011

Participant flow

Participant flow — Overall Study
MilestonePPX ER (Previous Placebo)PPX ER (Previous PPX ER)PPX ER (Previous PPX IR)
Started129123139
Completed113104112
Not completed161927
Withdrew: Adverse event11714
Withdrew: Protocol violation011
Withdrew: Lost to follow-up034
Withdrew: Withdrawal by subject556
Withdrew: Other032

Outcome measures

SecondaryPatients Successfully Switched From Pramipexole (PPX) IR or ER to ER Assessed on UPDRS II+III

Unified Parkinson's Disease Rating Scale (UPDRS) Successfully switched means: UPDRS II+III baseline score \>20 without a relative worsening of UPDRS II+III score \> 15% from baseline or UPDRS II+III baseline score \<=20 without an absolute worsening of UPDRS II+III score \> 3 from baseline UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms

Time frame:
One week
Reported as:
Number · Patients
Patients Successfully Switched From Pramipexole (PPX) IR or ER to ER Assessed on UPDRS II+III
PatientsPPX ER (Previous PPX ER)PPX ER (Previous PPX IR)
Patients Successfully Switched From Pramipexole (PPX) IR or ER to ER Assessed on UPDRS II+III88106
SecondaryUPDRS II+III Change From Open Label (OL) Baseline

UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms

Time frame:
OL Baseline and week 80
Reported as:
Least squares mean · Scores on a scale
UPDRS II+III Change From Open Label (OL) Baseline
Scores on a scalePPX ER (Previous Placebo)PPX ER (Previous PPX ER)PPX ER (Previous PPX IR)
UPDRS II+III Change From Open Label (OL) Baseline-3.6 ± 1.51.1 ± 1.62.5 ± 1.5
Statistical analysis
  • PPX ER (Previous Placebo) vs PPX ER (Previous PPX ER) · ANCOVA · p = 0.0039Analysis of covariance (ANCOVA) with factors treatment and country and covariate OL baseline
  • PPX ER (Previous Placebo) vs PPX ER (Previous PPX IR) · ANCOVA · p = 0.0001Analysis of covariance (ANCOVA) with factors treatment and country and covariate OL baseline
SecondaryNumber of Participants With UPDRS II+III Response

A response means an improvement of \>=20% in UPDRS II+III from OL baseline UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms

Time frame:
Week 80
Reported as:
Number · Patients
Number of Participants With UPDRS II+III Response
PatientsPPX ER (Previous Placebo)PPX ER (Previous PPX ER)PPX ER (Previous PPX IR)
Number of Participants With UPDRS II+III Response353031
SecondaryNumber of Patients Successfully Switched From PPX IR or ER to ER Assessed on Off-time

A patient was considered as successfully switched if he/she has converted to ER without a worsening of off time by more than 12.5% from baseline. Off-time is based on patient diary data and describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).

Time frame:
One week
Reported as:
Number · Patients
Number of Patients Successfully Switched From PPX IR or ER to ER Assessed on Off-time
PatientsPPX ER (Previous PPX ER)PPX ER (Previous PPX IR)
Number of Patients Successfully Switched From PPX IR or ER to ER Assessed on Off-time5770
SecondaryPercentage Off Time During Waking Hours Total Score: Change From Baseline

Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). A negative change implies improvement

Time frame:
Baseline and week 80
Reported as:
Least squares mean · percentage during waking hours
Percentage Off Time During Waking Hours Total Score: Change From Baseline
percentage during waking hoursPPX ER (Previous Placebo)PPX ER (Previous PPX ER)PPX ER (Previous PPX IR)
Percentage Off Time During Waking Hours Total Score: Change From Baseline-1.5 ± 2.0-0.3 ± 2.11.7 ± 2.0
Statistical analysis
  • PPX ER (Previous Placebo) vs PPX ER (Previous PPX ER) · ANCOVA · p = 0.5590Analysis of covariance with factors for treatment, country and baseline as a covariate
  • PPX ER (Previous Placebo) vs PPX ER (Previous PPX IR) · ANCOVA · p = 0.1289Analysis of covariance with factors for treatment, country and baseline as a covariate
SecondaryNumber of Participants With Response in Percentage Off Time During Waking Hours

Response means \>=20% improvement relative to OL baseline in the % off-time during waking hours

Time frame:
80 weeks
Reported as:
Number · Patients
Number of Participants With Response in Percentage Off Time During Waking Hours
PatientsPPX ER (Previous Placebo)PPX ER (Previous PPX ER)PPX ER (Previous PPX IR)Total PPX ER
Number of Participants With Response in Percentage Off Time During Waking Hours354028103
SecondaryPercentage on Time Without Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks

Percentage on-time based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement.

Time frame:
Baseline and week 80
Reported as:
Least squares mean · percentage during waking hours
Percentage on Time Without Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks
percentage during waking hoursPPX ER (Previous Placebo)PPX ER (Previous PPX ER)PPX ER (Previous PPX IR)
Percentage on Time Without Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks-1.6 ± 2.52.9 ± 2.7-2.0 ± 2.6
Statistical analysis
  • PPX ER (Previous Placebo) vs PPX ER (Previous PPX ER) · ANCOVA · p = 0.1073Analysis of covariance with factors for treatment, country and baseline as a covariate
  • PPX ER (Previous Placebo) vs PPX ER (Previous PPX IR) · ANCOVA · p = 0.8694Analysis of covariance with factors for treatment, country and baseline as a covariate
SecondaryPercentage on Time With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks

Percentage on-time with non troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement

Time frame:
Baseline and week 80
Reported as:
Least squares mean · percentage during waking hours
Percentage on Time With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks
percentage during waking hoursPPX ER (Previous Placebo)PPX ER (Previous PPX ER)PPX ER (Previous PPX IR)
Percentage on Time With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks3.8 ± 1.8-2.7 ± 1.90.2 ± 1.8
Statistical analysis
  • PPX ER (Previous Placebo) vs PPX ER (Previous PPX ER) · ANCOVA · p = 0.0009Analysis of covariance with factors for treatment, country and baseline as a covariate
  • PPX ER (Previous Placebo) vs PPX ER (Previous PPX IR) · ANCOVA · p = 0.0573Analysis of covariance with factors for treatment, country and baseline as a covariate
SecondaryPercentage on Time Without Dyskinesia or With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks

Percentage on-time without dyskinesia or with non troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement

Time frame:
Baseline and week 80
Reported as:
Least squares mean · percentage during waking hours
Percentage on Time Without Dyskinesia or With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks
percentage during waking hoursPPX ER (Previous Placebo)PPX ER (Previous PPX ER)PPX ER (Previous PPX IR)
Percentage on Time Without Dyskinesia or With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks1.8 ± 2.20.7 ± 2.3-0.9 ± 2.3
Statistical analysis
  • PPX ER (Previous Placebo) vs PPX ER (Previous PPX ER) · ANCOVA · p = 0.6434Analysis of covariance with factors for treatment, country and baseline as a covariate
  • PPX ER (Previous Placebo) vs PPX ER (Previous PPX IR) · ANCOVA · p = 0.2469Analysis of covariance with factors for treatment, country and baseline as a covariate
SecondaryPercentage on Time With Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks

Percentage on-time with troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement

Time frame:
Baseline and week 80
Reported as:
Least squares mean · percentage during waking hours
Percentage on Time With Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks
percentage during waking hoursPPX ER (Previous Placebo)PPX ER (Previous PPX ER)PPX ER (Previous PPX IR)
Percentage on Time With Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks-0.4 ± 1.0-0.3 ± 1.1-0.7 ± 1.1
Statistical analysis
  • PPX ER (Previous Placebo) vs PPX ER (Previous PPX ER) · ANCOVA · p = 0.9741Analysis of covariance with factors for treatment, country and baseline as a covariate
  • PPX ER (Previous Placebo) vs PPX ER (Previous PPX IR) · ANCOVA · p = 0.7620Analysis of covariance with factors for treatment, country and baseline as a covariate
SecondaryNumber of Participants With Response in CGI-I

Clinical Global Impression of Improvement (CGI-I), CGI-I scores ranging from '1' (very much improved) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least "much improved" were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much improved were considered as responders

Time frame:
32 weeks
Reported as:
Number · Patients
Number of Participants With Response in CGI-I
PatientsPPX ER (Previous Placebo)PPX ER (Previous PPX ER)PPX ER (Previous PPX IR)Total PPX ER
Number of Participants With Response in CGI-I50106114270
SecondaryNumber of Participants With Response in PGI-I

Patient Global Impression of Improvement (PGI-I), PGI-I scores ranging from '1' (very much better) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least "much better" were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much better were considered as responders

Time frame:
32 weeks
Reported as:
Number · Patients
Number of Participants With Response in PGI-I
PatientsPPX ER (Previous Placebo)PPX ER (Previous PPX ER)PPX ER (Previous PPX IR)Total PPX ER
Number of Participants With Response in PGI-I45102113260
SecondaryNumber of Participants With Response in PGI-I for Early Morning Off Symptoms

Patient Global Impression of Improvement (PGI-I) for early morning off symptoms, PGI-I scores ranging from '1' (very much better) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least "much better" were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much better were considered as responders

Time frame:
32 weeks
Reported as:
Number · Patients
Number of Participants With Response in PGI-I for Early Morning Off Symptoms
PatientsPPX ER (Previous Placebo)PPX ER (Previous PPX ER)PPX ER (Previous PPX IR)Total PPX ER
Number of Participants With Response in PGI-I for Early Morning Off Symptoms45103112260
SecondaryUPDRS I Total Score and Change From OL Baseline at Week 80

UPDRS I ranging from 0 (normal) to 16 (severe). UPDRS I measures Mentation, Behavior and Mood

Time frame:
OL baseline and week 80
Reported as:
Least squares mean · units on a scale
UPDRS I Total Score and Change From OL Baseline at Week 80
units on a scalePPX ER (Previous Placebo)PPX ER (Previous PPX ER)PPX ER (Previous PPX IR)
UPDRS I Total Score and Change From OL Baseline at Week 800.1 ± 0.20.5 ± 0.20.5 ± 0.2
Statistical analysis
  • PPX ER (Previous Placebo) vs PPX ER (Previous PPX ER) · ANCOVA · p = 0.0831Analysis of covariance with factors for treatment, country and baseline as a covariate
  • PPX ER (Previous Placebo) vs PPX ER (Previous PPX IR) · ANCOVA · p = 0.0759Analysis of covariance with factors for treatment, country and baseline as a covariate
SecondaryUPDRS II Total Score and Change From OL Baseline at Week 80

UPDRS II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS part II at on and UPDRS part II at off-period for each of the 13 activities

Time frame:
OL baseline and week 80
Reported as:
Least squares mean · units on a scale
UPDRS II Total Score and Change From OL Baseline at Week 80
units on a scalePPX ER (Previous Placebo)PPX ER (Previous PPX ER)PPX ER (Previous PPX IR)
UPDRS II Total Score and Change From OL Baseline at Week 80-0.4 ± 0.50.4 ± 0.61.0 ± 0.5
Statistical analysis
  • PPX ER (Previous Placebo) vs PPX ER (Previous PPX ER) · ANCOVA · p = 0.1713Analysis of covariance with factors for treatment, country and baseline as a covariate
  • PPX ER (Previous Placebo) vs PPX ER (Previous PPX IR) · ANCOVA · p = 0.0130Analysis of covariance with factors for treatment, country and baseline as a covariate
SecondaryUPDRS III Total Score and Change From OL Baseline at Week 80

UPDRS III ranging from 0 (normal) to 108 (severe). UPDRS part III measures motor symptoms

Time frame:
OL baseline and week 80
Reported as:
Least squares mean · units on a scale
UPDRS III Total Score and Change From OL Baseline at Week 80
units on a scalePPX ER (Previous Placebo)PPX ER (Previous PPX ER)PPX ER (Previous PPX IR)
UPDRS III Total Score and Change From OL Baseline at Week 80-3.1 ± 1.10.7 ± 1.11.3 ± 1.1
Statistical analysis
  • PPX ER (Previous Placebo) vs PPX ER (Previous PPX ER) · ANCOVA · p = 0.0015Analysis of covariance with factors for treatment, country and baseline as a covariate
  • PPX ER (Previous Placebo) vs PPX ER (Previous PPX IR) · ANCOVA · p = 0.0002Analysis of covariance with factors for treatment, country and baseline as a covariate
SecondaryUPDRS IV Total Score and Change From OL Baseline at Week 80

UPDRS IV ranging from 0 (normal) to 23 (severe). UPDRS IV measures complications of therapy

Time frame:
OL baseline and week 80
Reported as:
Least squares mean · Unit on a scale
UPDRS IV Total Score and Change From OL Baseline at Week 80
Unit on a scalePPX ER (Previous Placebo)PPX ER (Previous PPX ER)PPX ER (Previous PPX IR)
UPDRS IV Total Score and Change From OL Baseline at Week 800.0 ± 0.2-0.0 ± 0.30.2 ± 0.2
Statistical analysis
  • PPX ER (Previous Placebo) vs PPX ER (Previous PPX ER) · ANCOVA · p = 0.8760Analysis of covariance with factors for treatment, country and baseline as a covariate
  • PPX ER (Previous Placebo) vs PPX ER (Previous PPX IR) · ANCOVA · p = 0.5113Analysis of covariance with factors for treatment, country and baseline as a covariate
SecondaryParkinson Fatigue Scale (PFS-16) Score and Change From OL Baseline at Week 80

PFS-16 (Parkinson fatigue scale) ranging from 16 (better perceived health status) to 80 (severe symptoms of the disease) measuring aspects of fatigue that are relevant to patients with PD

Time frame:
OL baseline and week 80
Reported as:
Least squares mean · Unit on a scale
Parkinson Fatigue Scale (PFS-16) Score and Change From OL Baseline at Week 80
Unit on a scalePPX ER (Previous Placebo)PPX ER (Previous PPX ER)PPX ER (Previous PPX IR)
Parkinson Fatigue Scale (PFS-16) Score and Change From OL Baseline at Week 80-0.3 ± 1.53.8 ± 1.63.5 ± 1.6
Statistical analysis
  • PPX ER (Previous Placebo) vs PPX ER (Previous PPX ER) · ANCOVA · p = 0.0148Analysis of covariance with factors for treatment, country and baseline as a covariate
  • PPX ER (Previous Placebo) vs PPX ER (Previous PPX IR) · ANCOVA · p = 0.0201Analysis of covariance with factors for treatment, country and baseline as a covariate
SecondaryNumber of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80
Time frame:
OL baseline and week 80
Reported as:
Number · Patients
Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80
PatientsPPX ER (Previous Placebo)PPX ER (Previous PPX ER)PPX ER (Previous PPX IR)Total PPX ER
Decrease24121248
Increase8182753
No change938493270
SecondaryNumber of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline
Time frame:
OL baseline and week 80
Reported as:
Number · Patients
Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline
PatientsPPX ER (Previous Placebo)PPX ER (Previous PPX ER)PPX ER (Previous PPX IR)Total PPX ER
Reduced563326115
Unchanged404353136
Increased293947115
SecondaryNumber of Participants With Serious Adverse Events
Time frame:
80 weeks
Reported as:
Number · Patients
Number of Participants With Serious Adverse Events
PatientsPPX ER (Previous Placebo)PPX ER (Previous PPX ER)PPX ER (Previous PPX IR)Total PPX ER
Number of Participants With Serious Adverse Events14111439
PrimaryPercentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events

The aim of this study was to obtain long-term safety and tolerability data on pramipexole ER, in patients who have previously completed a pramipexole double blind study in advanced Parkinson's Disease (PD) (248.525 (NCT00466167)). Therefore these items were considered as a safety evaluation.

Time frame:
80 weeks
Reported as:
Number · Percentage of participants
Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events
Percentage of participantsPlaceboPPX ERPPX IR
Percentage of Patients with Adverse Events85.383.779.9
Percentage of Patients with Adverse Drug Reactions52.748.845.3
Percentage of Patients with Serious Adverse Events10.98.910.1
SecondarySupine Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
Time frame:
OL Baseline and Week 80
Reported as:
Mean · mm Hg
Supine Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
mm HgPPX ER (Previous Placebo)PPX ER (Previous PPX ER)PPX ER (Previous PPX IR)
OL Baseline77.4 ± 8.977.3 ± 8.677.6 ± 9.4
End of OL77.4 ± 8.978.3 ± 8.977.2 ± 8.3
SecondaryStanding Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
Time frame:
OL Baseline and Week 80
Reported as:
Mean · mm Hg
Standing Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
mm HgPPX ER (Previous Placebo)PPX ER (Previous PPX ER)PPX ER (Previous PPX IR)
OL Baseline77.8 ± 9.277.3 ± 9.177.6 ± 9.9
End of OL77.6 ± 9.178.1 ± 9.376.4 ± 9.7
SecondarySupine Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
Time frame:
OL Baseline and Week 80
Reported as:
Mean · mm Hg
Supine Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
mm HgPPX ER (Previous Placebo)PPX ER (Previous PPX ER)PPX ER (Previous PPX IR)
OL Baseline121.6 ± 12.2124.5 ± 15.4125.7 ± 14.8
End of OL124.2 ± 13.5123.8 ± 14.2124.4 ± 14.7
SecondaryStanding Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
Time frame:
OL Baseline and Week 80
Reported as:
Mean · mm Hg
Standing Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
mm HgPPX ER (Previous Placebo)PPX ER (Previous PPX ER)PPX ER (Previous PPX IR)
OL Baseline120.2 ± 13.9121.1 ± 16.4120.9 ± 15.9
End of OL121.9 ± 15.0121.6 ± 14.3120.5 ± 16.0
SecondarySupine Pulse Rate, Baseline and Week 80, Vital Signs Treated Set
Time frame:
OL Baseline and Week 80
Reported as:
Mean · beats per minute
Supine Pulse Rate, Baseline and Week 80, Vital Signs Treated Set
beats per minutePPX ER (Previous Placebo)PPX ER (Previous PPX ER)PPX ER (Previous PPX IR)
OL Baseline73.6 ± 9.672.6 ± 9.273.2 ± 9.0
End of OL75.8 ± 9.074.2 ± 7.974.4 ± 10.0
SecondaryStanding Pulse Rate, Baseline and Week 80, Vital Signs Treated Set
Time frame:
OL Baseline and Week 80
Reported as:
Mean · beats per minute
Standing Pulse Rate, Baseline and Week 80, Vital Signs Treated Set
beats per minutePPX ER (Previous Placebo)PPX ER (Previous PPX ER)PPX ER (Previous PPX IR)
OL Baseline78.3 ± 10.778.0 ± 9.577.7 ± 9.9
End of OL79.3 ± 8.777.7 ± 7.578.8 ± 10.4
SecondaryBody Weight of Female Patients, Baseline and Week 80, Vital Signs Treated Set
Time frame:
OL Baseline and Week 80
Reported as:
Mean · kg
Body Weight of Female Patients, Baseline and Week 80, Vital Signs Treated Set
kgPPX ER (Previous Placebo)PPX ER (Previous PPX ER)PPX ER (Previous PPX IR)
OL Baseline61.9 ± 13.061.7 ± 14.063.8 ± 14.6
End of OL63.6 ± 13.861.7 ± 15.063.6 ± 16.0
SecondaryBody Weight of Male Patients, Baseline and Week 80, Vital Signs Treated Set
Time frame:
OL Baseline and Week 80
Reported as:
Mean · kg
Body Weight of Male Patients, Baseline and Week 80, Vital Signs Treated Set
kgPPX ER (Previous Placebo)PPX ER (Previous PPX ER)PPX ER (Previous PPX IR)
OL Baseline73.0 ± 15.772.1 ± 12.270.8 ± 13.2
End of OL73.9 ± 16.472.7 ± 12.572.0 ± 14.0
SecondaryEpworth Sleepiness Scale (ESS), Baseline and End of Open Label, Treated Set

ESS Total score ranges from zero (best) to 24 (worst); scale has 8 items, each rated from zero (no chance of dozing) to 3 (high chance of dozing)

Time frame:
OL Baseline and Week 80
Reported as:
Mean · units on a scale
Epworth Sleepiness Scale (ESS), Baseline and End of Open Label, Treated Set
units on a scalePPX ER (Previous Placebo)PPX ER (Previous PPX ER)PPX ER (Previous PPX IR)
OL Baseline7.2 ± 4.68.1 ± 4.18.1 ± 4.9
Change from baseline at end of OL0.5 ± 5.11.2 ± 4.71.2 ± 4.8
SecondaryModified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set

The mMIDI is a semi-structured interview designed to assess impulsive control disorders. The scale was modified to focus behaviors of: pathological gambling, compulsive buying and compulsive sexual behavioral.

Time frame:
Baseline, 80 weeks
Reported as:
Number · participants
Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set
participantsPPX ER (Previous Placebo)PPX ER (Previous PPX ER)PPX ER (Previous PPX IR)
Abnormal behavior - pathological gambling000
Abnormal behavior - compulsive buying202
Abnormal behavior - compulsive sexual behavior220

Adverse events

Collected over 80 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
PPX ER (Previous Placebo)—14/129 (10.9%)87/129 (67.4%)
PPX ER (Previous PPX ER)—11/123 (8.9%)74/123 (60.2%)
PPX ER (Previous PPX IR)—14/139 (10.1%)81/139 (58.3%)
Total PPX ER—39/391 (10%)242/391 (61.9%)
Most frequent serious events
Showing 10 of 62
Most frequent serious events
EventPPX ER (Previous Placebo)PPX ER (Previous PPX ER)PPX ER (Previous PPX IR)Total PPX ER
FallInjury, poisoning and procedural complications3/1290/1232/1395/391
Acute myocardial infarctionCardiac disorders0/1291/1230/1391/391
Coronary artery diseaseCardiac disorders0/1291/1230/1391/391
Multi-organ failureGeneral disorders0/1291/1230/1391/391
AppendicitisInfections and infestations0/1291/1230/1391/391
PneumoniaInfections and infestations1/1291/1231/1393/391
Septic shockInfections and infestations0/1291/1230/1391/391
UrosepsisInfections and infestations0/1291/1230/1391/391
Femoral neck fractureInjury, poisoning and procedural complications1/1291/1230/1392/391
Pain in extremityMusculoskeletal and connective tissue disorders0/1291/1230/1391/391
Most frequent other events
Showing 10 of 17
Most frequent other events
EventPPX ER (Previous Placebo)PPX ER (Previous PPX ER)PPX ER (Previous PPX IR)Total PPX ER
DyskinesiaNervous system disorders41/12933/12332/139106/391
SomnolenceNervous system disorders15/12918/12319/13952/391
DizzinessNervous system disorders13/12911/1234/13928/391
InsomniaPsychiatric disorders10/12910/1237/13927/391
NauseaGastrointestinal disorders10/1297/1237/13924/391
HallucinationPsychiatric disorders10/1296/1236/13922/391
FallInjury, poisoning and procedural complications8/1299/1236/13923/391
CataractEye disorders9/1298/1236/13923/391
DystoniaNervous system disorders4/1298/1237/13919/391
Muscle rigidityMusculoskeletal and connective tissue disorders1/1292/1239/13912/391

Baseline characteristics

Treated Set, all patients dispensed study drug and documented to have taken at least one dose

Age, Continuous
Age, Continuous(Years)PPX ER (Previous Placebo)PPX ER (Previous PPX ER)PPX ER (Previous PPX IR)Total
Mean61.3 ± 9.761.7 ± 9.861.8 ± 9.761.6 ± 9.7
Sex: Female, Male
Sex: Female, Male(Participants)PPX ER (Previous Placebo)PPX ER (Previous PPX ER)PPX ER (Previous PPX IR)Total
Female585565178
Male716874213
08

Study locations

70 sites
  • 248.634.43005 Boehringer Ingelheim Investigational Site
    Linz, Austria
  • 248.634.42003 Boehringer Ingelheim Investigational Site
    Pardubice, Czech Republic
  • 248.634.42001 Boehringer Ingelheim Investigational Site
    Praha, Czech Republic
  • 248.634.42005 Boehringer Ingelheim Investigational Site
    Rakovnik, Czech Republic
  • 248.634.42002 Boehringer Ingelheim Investigational Site
    Rychnov nad Kneznou, Czech Republic
  • 248.634.42004 Boehringer Ingelheim Investigational Site
    Valasske Mezirici, Czech Republic
  • 248.634.36005 Boehringer Ingelheim Investigational Site
    Györ, Hungary
  • 248.634.36003 Boehringer Ingelheim Investigational Site
    Kecskemét, Hungary
  • 248.634.36006 Boehringer Ingelheim Investigational Site
    Szeged, Hungary
  • 248.634.36004 Boehringer Ingelheim Investigational Site
    Veszprem, Hungary
  • 248.634.91002 Boehringer Ingelheim Investigational Site
    Chennai, India
  • 248.634.91001 Boehringer Ingelheim Investigational Site
    Delhi, India
  • 248.634.91003 Boehringer Ingelheim Investigational Site
    Hyderabad, India
  • 248.634.91007 Boehringer Ingelheim Investigational Site
    Indore, India
  • 248.634.91005 Boehringer Ingelheim Investigational Site
    Karnataka, India
  • 248.634.91006 Boehringer Ingelheim Investigational Site
    Pune, India
  • 248.634.39001 Boehringer Ingelheim Investigational Site
    Catania, Italy
  • 248.634.39010 Boehringer Ingelheim Investigational Site
    Catanzaro, Italy
  • 248.634.39009 Boehringer Ingelheim Investigational Site
    Chieti, Italy
  • 248.634.39007 Boehringer Ingelheim Investigational Site
    Grosseto, Italy
  • 248.634.39002 Boehringer Ingelheim Investigational Site
    Napolii, Italy
  • 248.634.39008 Boehringer Ingelheim Investigational Site
    Pisa, Italy
  • 248.634.39005 Boehringer Ingelheim Investigational Site
    Roma, Italy
  • 248.634.39011 Boehringer Ingelheim Investigational Site
    Roma, Italy
  • 248.634.82001 Boehringer Ingelheim Investigational Site
    Gyeonggi-do, Korea, Republic of
  • 248.634.82008 Boehringer Ingelheim Investigational Site
    Kyeonggi-do, Korea, Republic of
  • 248.634.82007 Boehringer Ingelheim Investigational Site
    Pusan, Korea, Republic of
  • 248.634.82002 Boehringer Ingelheim Investigational Site
    Seoul, Korea, Republic of
  • 248.634.82003 Boehringer Ingelheim Investigational Site
    Seoul, Korea, Republic of
  • 248.634.82004 Boehringer Ingelheim Investigational Site
    Seoul, Korea, Republic of
  • 248.634.82005 Boehringer Ingelheim Investigational Site
    Seoul, Korea, Republic of
  • 248.634.82006 Boehringer Ingelheim Investigational Site
    Seoul, Korea, Republic of
  • 248.634.63202 Boehringer Ingelheim Investigational Site
    Cruz, Manila, Philippines
  • 248.634.63207 Boehringer Ingelheim Investigational Site
    Ermita, Manila, Philippines
  • 248.634.63210 Boehringer Ingelheim Investigational Site
    Makati City, Philippines
  • 248.634.63205 Boehringer Ingelheim Investigational Site
    Manila, Philippines
  • 248.634.63206 Boehringer Ingelheim Investigational Site
    Manila, Philippines
  • 248.634.63201 Boehringer Ingelheim Investigational Site
    Pasig City, Philippines
  • 248.634.63204 Boehringer Ingelheim Investigational Site
    Quezon City, Philippines
  • 248.634.63208 Boehringer Ingelheim Investigational Site
    Quezon, Philippines
  • 248.634.48001 Boehringer Ingelheim Investigational Site
    Gdansk, Poland
  • 248.634.48003 Boehringer Ingelheim Investigational Site
    Krakow, Poland
  • 248.634.48002 Boehringer Ingelheim Investigational Site
    Warsaw, Poland
  • 248.634.07001 Boehringer Ingelheim Investigational Site
    Moscow, Russian Federation
  • 248.634.07002 Boehringer Ingelheim Investigational Site
    Moscow, Russian Federation
  • 248.634.07003 Boehringer Ingelheim Investigational Site
    Moscow, Russian Federation
  • 248.634.07004 Boehringer Ingelheim Investigational Site
    Moscow, Russian Federation
  • 248.634.07007 Boehringer Ingelheim Investigational Site
    Moscow, Russian Federation
  • 248.634.07006 Boehringer Ingelheim Investigational Site
    St. Petersburg, Russian Federation
  • 248.634.42104 Boehringer Ingelheim Investigational Site
    Bratislava, Slovakia
  • 248.634.42105 Boehringer Ingelheim Investigational Site
    Bratislava, Slovakia
  • 248.634.42103 Boehringer Ingelheim Investigational Site
    Dubnica nad Vahom, Slovakia
  • 248.634.42101 Boehringer Ingelheim Investigational Site
    Trnava, Slovakia
  • 248.634.34001 Boehringer Ingelheim Investigational Site
    Alcorcon (Madrid), Spain
  • 248.634.34003 Boehringer Ingelheim Investigational Site
    Barcelona, Spain
  • 248.634.34004 Boehringer Ingelheim Investigational Site
    Barcelona, Spain
  • 248.634.34005 Boehringer Ingelheim Investigational Site
    Madrid, Spain
  • 248.634.34002 Boehringer Ingelheim Investigational Site
    San Cugat del Valles (Barcelona), Spain
  • 248.634.34008 Boehringer Ingelheim Investigational Site
    Tarrasa (Barcelona), Spain
  • 248.634.46005 Boehringer Ingelheim Investigational Site
    Malmö, Sweden
  • 248.634.46002 Boehringer Ingelheim Investigational Site
    Nyköping, Sweden
  • 248.634.46001 Boehringer Ingelheim Investigational Site
    Stockholm, Sweden
  • 248.634.38003 Boehringer Ingelheim Investigational Site
    Dnipropetrovsk, Ukraine
  • 248.634.38006 Boehringer Ingelheim Investigational Site
    Kharkiv, Ukraine
  • 248.634.38002 Boehringer Ingelheim Investigational Site
    Kiev, Ukraine
  • 248.634.38004 Boehringer Ingelheim Investigational Site
    Kiev, Ukraine
  • 248.634.38005 Boehringer Ingelheim Investigational Site
    Zaporizhzhya, Ukraine
  • 248.634.38001 Boehringer Ingelheim Investigational Site
    Zaporozhye, Ukraine
  • 248.634.44007 Boehringer Ingelheim Investigational Site
    Blackburn, United Kingdom
  • 248.634.44003 Boehringer Ingelheim Investigational Site
    Salford, United Kingdom
09

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 ↗
10

Registry details

Key details

Study ID
NCT00577460
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Dec 20, 2007
Start date
Dec 2007
Primary completion
Jun 2010
Results posted
Jul 14, 2011
Last update
May 16, 2014

Study contacts

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

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