Purpose

A Phase 3, Twelve-week, Multi-Center, Multinational, Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to its Individual Components in Subjects With Early Parkinson's Disease and to a Calibration Arm of Pramipexole ER.

Condition

Eligibility

Eligible Ages
Between 35 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Subject has Parkinson's disease consistent with the UK Brain Bank Criteria and must have bradykinesia with sequence effect. If rest tremor does not exist must have prominent asymmetry of motor function. 2. Subject with disease duration less than 3 years since diagnosis. 3. Subject has a H&Y stage score of < 3. 4. Subject has a MMSE score ≥ 26.

Exclusion Criteria

  1. Subject has an atypical parkinsonian syndrome or secondary parkinsonism 2. 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. 3. 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. 4. Subject who has taken anticholinergic drugs for PD or amantadine for longer than 4 weeks; if previous exposure was less than 4 weeks then it must not be within 1 month prior to the baseline visit. 5. Subject has moderate (Child-Pugh categorization B, score 7-9) or severe (Child-Pugh categorization C, score 10-15) hepatic impairment.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
4 arms
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)
Masking Description
double blind study

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
P2B001
Fixed dose combination once daily capsule of pramipexole and rasagiline
  • Drug: P2B001
    Fixed dose once daily combination capsule of pramipexole and rasagiline
    Other names:
    • Fixed dose combination of Pramipexole and rasagiline
Experimental
rasagiline capsule
rasagiline Once daily capsule
  • Drug: Rasagiline
    Rasagiline oral capsule
    Other names:
    • rasagiline capsule
Experimental
Pramipexole capsule
Pramipexole once daily capsule
  • Drug: Pramipexole
    Pramipexole low dose oral capsule
    Other names:
    • Pramipexole capsule
Active Comparator
Pramipexole Extended Release
pramipexole ER tablet titrated to optimal dose of 1.5, 3.0 or 4.5mg
  • Drug: Pramipexole ER
    Pramipexole ER titrated to optimal dose
    Other names:
    • Pramipexole Extended Release Oral Tablet

Recruiting Locations

P2B001/003 study site Boston
Boston, Massachusetts 02118
Contact:
Raymond James
rcjames@bu.edu

More Details

Status
Recruiting
Sponsor
Pharma Two B Ltd.

Study Contact

Avigail Glass
89472672
Avigail@pharma2b.com

Detailed Description

A total of 525 eligible subjects with early untreated Parkinson's disease (PD), will be randomized to 4 treatment groups. Each subject will participate in the study for approximately 18 weeks including a 30 day screening period, 12 week treatment period, and 2 weeks follow-up period.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.