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CompletedNCT01968460Updated Apr 7, 2023Results posted

Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease

A Phase 2/3 interventional study of P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg), and Placebo in Parkinson's Disease, sponsored by Pharma Two B Ltd.. Completed at 29 sites in 2 countries. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-04-07.

Sponsored by Pharma Two B Ltd. · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
149
Allocation
Randomized
Ages
35 Years to 75 Years
Sex
All
01

Study summary

This study will evaluate an oral fixed-dose, once daily product that combines pramipexole and rasagiline for the treatment of early Parkinson's disease.

Animal studies support the therapeutic advantage of combining low doses of rasagiline and pramipexole and suggest further improvement when both are administered in a sustained fashion. Both rasagiline and pramipexole are well known marketed drugs for Parkinson's disease with a good safety profile. combining the drugs in low doses and controlled release may provide better symptom management than the existing drugs alone or together.

02

Conditions studied

  • Parkinson's Disease

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Keywords

  • Parkinson's Disease, Rasagiline, Pramipexole
03

In context

Parkinson Disease

4,484 studies on the registry are indexed under Parkinson Disease; 1,081 are open to participants now.

This study's enrollment of 149 is above the median of 40 across 3,293 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Pharma Two B Ltd. is the lead sponsor of 2 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
35 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subject is male or female ≥35 years of age to ≤75 years of age at the time of enrollment.
  • Subject has idiopathic Parkinson's disease consistent with the UK Brain Bank Criteria; must have bradykinesia with sequence effect and rest tremor or prominent motor asymmetry.
  • Subject with disease duration no longer than 3 years and 0 months.
  • Subject has a Hoehn \& Yahr (H\&Y) stage score of \< 3.
  • Subject has a MMSE score ≥ 26

Exclusion criteria

Exclusion Criteria:

  • Subject has an atypical parkinsonian syndrome or secondary parkinsonism (e.g., due to drugs, metabolic neurogenetic disorders, encephalitis, cerebrovascular disease or degenerative disease).
  • Subject has a history of psychosis or hallucinations within the previous 12 months.
  • Subject who is taking anticholinergic drugs.
  • Subject has previous exposure to levodopa or a dopamine agonist for longer than 4 weeks; if previous exposure was less than 4 weeks then it must not be within 2 months prior to the baseline visit.
  • Subject has previous exposure to a MAO-B inhibitor for longer than 4 weeks; if previous exposure was less than 4 weeks then it must not be within 3 months prior to the baseline visit.
  • Subject who is taking MAO inhibitors, potent CYP1A2 inhibitors, e,g, Ciprofloxacin, Dextromethorphan or antitussive agent, analgesic agents such as tramadol, meperidine, methadone and propoxyphene, strong 3A4 inducers, e.g., St. John's Wort or cyclobenzaprine (tricyclic muscle relaxant), dopamine antagonists, such as the neuroleptics (phenothiazines, butyrophenones, thioxanthenes) or metoclopramide. Probenecid, cimetidine, ranitidine, diltiazem, verapamil and quinidine.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
149 participants (actual)

Study arms

  • Experimental
    P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),

    Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily.

    Drug: P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),

  • Experimental
    P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),

    Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily

    Drug: P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),

  • Placebo comparator
    Placebo

    Placebo once daily for 12 weeks.

    Drug: Placebo

Interventions

  • DrugP2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),

    Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily

  • DrugPlacebo

    placebo

  • DrugP2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),

    Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily

06

What researchers measure

Primary outcomes

  1. Total UPDRS I, II, III Scores

    Change from baseline to final visit (week 12) in total UPDRS score (defined as sum of parts I, II and III, scores (0-176). UPDRS- Unified Parkinson's Disease Rating Scale, minimum value is 0 points and maximum value is 176. High score mean worse outcome.

    Time frame: Week 12

Secondary outcomes

  1. UPDRS ADL (Part II)

    Change from baseline in individual UPDRS ADL (part II). Activity of daily Life UPDRS part II minimum is 0 point and max is 52 point (worse outcome)

    Time frame: Week 12

  2. CGI-S

    Change from baseline in individual Clinical Global Impression - Severity. Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness (Parkinson's Disease) at the time of assessment relative to the clinician's past experience with patients who have the same diagnosis as one of the following:. 1 is normal and 7 is the most extremely ill patients. A subject defined as a treatment responder when the improvement from baseline to the Week12 / Last Observed Value (LOV) was of at least 1 point or more.

    Time frame: 12 weeks

  3. UPDRS Motor (Part III)

    Change from baseline in individual UPDRS motor (part III). UPDRS- Unified Parkinson's Disease Rating Scale, part III motor . min is 0 and Max is 108 (Worse outcome)

    Time frame: 12 weeks

  4. PDQ39

    Change from baseline in individual Parkinson's Disease Questionnaire - 39. Score 0-100 where 0 is indicative of no problem at all and 100 is the maximum level of problem.

    Time frame: 12 weeks

07

Results

Posted Apr 7, 2023

Participant flow

Participant flow — Overall Study
MilestoneP2B001 Treatment AP2B001 Treatment BPlacebo
Started495050
Completed434548
Not completed652

Outcome measures

PrimaryTotal UPDRS I, II, III Scores

Change from baseline to final visit (week 12) in total UPDRS score (defined as sum of parts I, II and III, scores (0-176). UPDRS- Unified Parkinson's Disease Rating Scale, minimum value is 0 points and maximum value is 176. High score mean worse outcome.

Time frame:
Week 12
Reported as:
Least squares mean · units on a scale
Total UPDRS I, II, III Scores
units on a scaleP2B001 Treatment AP2B001 Treatment BPlacebo
Total UPDRS I, II, III Scores-5.97 ± 0.94-5.15 ± 0.9-1.31 ± 0.88
Statistical analysis
  • P2B001 Treatment A vs Placebo · MMRM · p = 0.0004 (The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.) · Mean difference (net): -4.67 · 95% CI -7.20 to -2.13
  • P2B001 Treatment B vs Placebo · MMRM · p = 0.0027 (The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.) · Mean difference (net): -3.84 · 95% CI -6.32 to -1.36
SecondaryUPDRS ADL (Part II)

Change from baseline in individual UPDRS ADL (part II). Activity of daily Life UPDRS part II minimum is 0 point and max is 52 point (worse outcome)

Time frame:
Week 12
Reported as:
Least squares mean · units on a scale
UPDRS ADL (Part II)
units on a scaleP2B001 Treatment AP2B001 Treatment BPlacebo
UPDRS ADL (Part II)-1.49 ± 0.37-1.06 ± 0.360.36 ± 0.39
Statistical analysis
  • P2B001 Treatment A vs Placebo · MMRM · p = 0.0004 (The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.) · Mean difference (net): -1.85 · 95% CI -2.86 to -0.84
  • P2B001 Treatment B vs Placebo · MMRM · p = 0.005 (The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.) · Mean difference (net): -1.42 · 95% CI -2.41 to 0.44
SecondaryCGI-S

Change from baseline in individual Clinical Global Impression - Severity. Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness (Parkinson's Disease) at the time of assessment relative to the clinician's past experience with patients who have the same diagnosis as one of the following:. 1 is normal and 7 is the most extremely ill patients. A subject defined as a treatment responder when the improvement from baseline to the Week12 / Last Observed Value (LOV) was of at least 1 point or more.

Time frame:
12 weeks
Reported as:
Count of participants · Participants
CGI-S
ParticipantsP2B001 Treatment AP2B001 Treatment BPlacebo
CGI-S1393
Statistical analysis
  • P2B001 Treatment A vs Placebo · Regression, Logistic · p = 0.0165 (The overall significance level for this study was 5% using two-tailed tests.) · Odds ratio (or): 8.10 · 95% CI 1.47 to 44.77
  • P2B001 Treatment B vs Placebo · Regression, Logistic · p = 0.111 (The overall significance level for this study will be 5% using two-tailed tests.) · Odds ratio (or): 4.23 · 95% CI 0.72 to 24.90
SecondaryUPDRS Motor (Part III)

Change from baseline in individual UPDRS motor (part III). UPDRS- Unified Parkinson's Disease Rating Scale, part III motor . min is 0 and Max is 108 (Worse outcome)

Time frame:
12 weeks
Reported as:
Mean · units on a scale
UPDRS Motor (Part III)
units on a scaleP2B001 Treatment AP2B001 Treatment BPlacebo
UPDRS Motor (Part III)-4.43 ± 0.74-3.95 ± 0.7-1.62 ± 0.69
Statistical analysis
  • P2B001 Treatment A vs Placebo · MMRM · p = 0.0058 (The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.) · Mean difference (net): -2.81 · 95% CI -4.80 to -0.83
  • P2B001 Treatment B vs Placebo · MMRM · p = 0.0191 (The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.) · Mean difference (net): -2.32 · 95% CI -4.26 to -0.39
SecondaryPDQ39

Change from baseline in individual Parkinson's Disease Questionnaire - 39. Score 0-100 where 0 is indicative of no problem at all and 100 is the maximum level of problem.

Time frame:
12 weeks
Reported as:
Least squares mean · units on a scale
PDQ39
units on a scaleP2B001 Treatment AP2B001 Treatment BPlacebo
PDQ39-3.01 ± 0.89-2.19 ± 0.880.26 ± 0.88
Statistical analysis
  • P2B001 Treatment A vs Placebo · Mixed Models Analysis · p = 0.0097 (The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.) · Mean difference (net): -3.27 · 95% CI -5.72 to -0.80
  • P2B001 Treatment B vs Placebo · Mixed Models Analysis · p = 0.0509 (The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.) · Mean difference (net): -2.45 · 95% CI -4.91 to -0.012

Adverse events

Collected over 14 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
P2B001 Treatment A0/49 (0%)1/49 (2%)37/49 (75.5%)
P2B001 Treatment B0/50 (0%)0/50 (0%)20/50 (40%)
Placebo0/50 (0%)0/50 (0%)24/50 (48%)
Most frequent serious events
Most frequent serious events
EventP2B001 Treatment AP2B001 Treatment BPlacebo
ACUTE MYOCARDIAL INFARCTIONCardiac disorders1/490/500/50
Most frequent other events
Most frequent other events
EventP2B001 Treatment AP2B001 Treatment BPlacebo
NAUSEAGastrointestinal disorders10/496/501/50
SOMNOLENCENervous system disorders8/494/500/50
DIZZINESSNervous system disorders5/492/504/50
nasopharyngitisInfections and infestations2/492/505/50
fatigueGeneral disorders4/491/501/50
tremorNervous system disorders4/493/503/50
headacheNervous system disorders1/491/504/50
orthostatic hypotensionVascular disorders2/491/504/50
insomniaPsychiatric disorders3/490/502/50

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)P2B001 Treatment AP2B001 Treatment BPlaceboTotal
<=18 years0000
Between 18 and 65 years25231866
>=65 years24273283
Age, Continuous
Age, Continuous(years)P2B001 Treatment AP2B001 Treatment BPlaceboTotal
Mean62 ± 863 ± 864 ± 763 ± 8
Sex: Female, Male
Sex: Female, Male(Participants)P2B001 Treatment AP2B001 Treatment BPlaceboTotal
Female14161949
Male353431100
Race (NIH/OMB)
Race (NIH/OMB)(Participants)P2B001 Treatment AP2B001 Treatment BPlaceboTotal
American Indian or Alaska Native0011
Asian0213
Native Hawaiian or Other Pacific Islander0000
Black or African American3418
White464347136
More than one race0101
Unknown or Not Reported0000
Region of Enrollment
Region of Enrollment(participants)P2B001 Treatment AP2B001 Treatment BPlaceboTotal
United States424242126
Israel78823
08

Study locations

29 sites
  • P2B001 Site Birmingham
    Birmingham, Alabama, United States
  • P2B001 Site Los Angeles
    Los Angeles, California, United States
  • P2B001 Site Aurora
    Aurora, Colorado, United States
  • P2B001 Manchester
    Manchester, Connecticut, United States
  • P2B001 Site New Haven
    New Haven, Connecticut, United States
  • P2B001 Site Boca Raton
    Boca Raton, Florida, United States
  • P2B001 Site Port Charlotte
    Port Charlotte, Florida, United States
  • P2B001 Site Tampa
    Tampa, Florida, United States
  • P2B001 Site Augusta
    Augusta, Georgia, United States
  • P2B001 site Chicago
    Chicago, Illinois 60612, United States
  • P2B001 Site Kansas City
    Kansas City, Kansas, United States
  • P2B001 Site Boston
    Boston, Massachusetts, United States
  • P2B001 Site west Bloomfield
    West Bloomfield, Michigan, United States
  • P2B001 Site Golden Valley
    Golden Valley, Minnesota, United States
  • P2B001 Site Camden
    Camden, New Jersey, United States
  • P2B001 Site New Brunswick
    New Brunswick, New Jersey, United States
  • P2B001 site Commack
    Commack, New York, United States
  • P2B001 Site New York
    New York, New York, United States
  • P2B001 Site Durham
    Durham, North Carolina, United States
  • P2B001 Site Cincinnati
    Cincinnati, Ohio, United States
  • P2B001 Site Toledo
    Toledo, Ohio, United States
  • P2B001 Site Tulsa
    Tulsa, Oklahoma, United States
  • P2B001 Site Houston
    Houston, Texas, United States
  • P2B001 Site Roanoke
    Roanoke, Virginia, United States
  • P2B001 Site Rambam Israel
    Haifa, Israel
  • P2B001 Site Belinson
    Pethch Tikva, Israel
  • P2B001 Site Sheba Medical Center
    Ramat Gan, Israel
  • P2B001 Site Asaf Harofe
    Rishon LeZion, Israel
  • P2B001 Site Sourasky Medical Center
    Tel Aviv, Israel
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01968460
Lead sponsor
Pharma Two B Ltd.
Responsible party
Sponsor
First posted
Oct 24, 2013
Start date
Dec 2013
Primary completion
May 2015
Completion
Jun 2015
Results posted
Apr 7, 2023
Last update
Apr 7, 2023

Study contacts

pninit litman, Ph.D
study director · Pharma Two B Ltd.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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