CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 149 enrolled
Drug / intervention
P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg), +2 moredrug
Likely dose
P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01968460
NCT01968460Phase 3Completed
CompareCT.gov

A Phase 2B, Twelve-week Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study, To Determine the Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease

Pharma Two B Ltd.·interventional·Posted Oct 24, 2013·Updated Apr 7, 2023

In Brief

A Phase 3 clinical trial evaluating P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),, Placebo, and 1 other intervention for Parkinson's Disease. Completed, enrolled 149 participants across 29 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease
CountriesIsrael, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 24, 2013
Enrollment StartDec 1, 2013
Primary CompletionMay 1, 2015
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 12.7 years ago

Interventions

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

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

Placebodrug

placebo

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

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