At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 391 enrolled
Drug / intervention
Pramipexole +1 moredrug
Likely dose
Pramipexole 4.5 mgfrom 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.
Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Advanced Parkinson's Disease (PD)
In Brief
A Phase 3 clinical trial evaluating Pramipexole and Placebo for Parkinson Disease. Completed, enrolled 391 participants across 70 sites in 14 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson Disease
CountriesAustria, Czechia, Hungary, India, Italy, Philippines, Poland, Russia, Slovakia, South Korea, Spain, Sweden, Ukraine, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2007
First PostedDec 2007
Primary CompletionJun 2010
TodayJul 2026
First PostedDec 20, 2007
Enrollment StartDec 1, 2007
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 18.5 years ago
Interventions
Pramipexoledrug
Pramipexole ER 0.375 -4.5 mg
Placebodrug
Placebo tablets identical to Pramipexole ER tablets