At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 511 enrolled
Drug / intervention
Placebo +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 Early Parkinson´s Disease (PD).
In Brief
A Phase 3 clinical trial evaluating Placebo and Pramipexole for Parkinson Disease. Completed, enrolled 511 participants across 119 sites in 15 countries.
Detailed Summary
The general aim of this study is to obtain long-term safety and tolerability data on pramipexole ER, in daily doses from 0.375mg to 4.5mg once daily (q.d), in patients who have previously completed a pramipexole double-blind study in early PD (248.524(NCT00479401) or 248.636(NCT00558025) trial).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson Disease
CountriesAustria, Czechia, Finland, France, Germany, Hungary, India, Japan, Malaysia, Netherlands, Russia, Slovakia, Taiwan, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2008
First PostedJan 2008
Primary CompletionJun 2010
TodayJul 2026
First PostedJan 28, 2008
Enrollment StartJan 1, 2008
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 18.4 years ago
Interventions
Placebodrug
Patient to receive placebo tablets identical to Pramipexole ER tablets. Only during transfer phase.
Pramipexoledrug
ER 0.375-4,5 mg