A Phase 3 Study With P2B001 in Subjects With Early Parkinson's
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.
- Parkinson Disease
- Eligible Ages
- Between 35 Years and 80 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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.
- 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.
- Phase 3
- Study Type
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- 4 arms
- Primary Purpose
- Triple (Participant, Care Provider, Investigator)
- Masking Description
- double blind study
|Fixed dose combination once daily capsule of pramipexole and rasagiline||
|rasagiline Once daily capsule||
|Pramipexole once daily capsule||
Pramipexole Extended Release
|pramipexole ER tablet titrated to optimal dose of 1.5, 3.0 or 4.5mg||
- Pharma Two B Ltd.
Study ContactAvigail Glass
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.