At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 98 enrolled
Drug / intervention
Pramipexole SR +1 moredrug
Likely dose
Not stated in 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.
A Two- Stage Multicenter, Open-label, Randomized, Active Controlled Parallel Group Study Comparing the Efficacy and Safety of Pramipexole SR Versus Pramipexole IR Administered Orally Over an 18-week Treatment on Nocturnal Symptoms in L-Dopa+ Treated Patients With Advanced Parkinson's Disease (PD)
In Brief
A Phase 4 clinical trial evaluating Pramipexole SR and Pramipexole IR for Parkinson Disease. Completed, enrolled 98 participants across 12 sites.
Detailed Summary
The main objective of the study is to explore firstly, then further evaluate and confirm the efficacy between Pramipexole Sustained Release (SR) versus Pramipexole Immediate Release (IR) on nocturnal symptoms (as measured by the change from baseline to the end of the maintenance period in Parkinson's Disease Sleep Scale 2nd version (PDSS-2) score) in L-dopa+ treated patients with advanced Parkinson's disease (PD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson Disease
CountriesChina
Collaborators--
Timeline
Phase 4CompletedFinished
20192020202120222023202420252026
First PostedMay 2018
Enrollment StartJul 2018
Primary CompletionJan 2020
TodayJul 2026
First PostedMay 11, 2018
Enrollment StartJul 3, 2018
Primary CompletionJan 7, 2020
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 8.1 years ago
Interventions
Pramipexole SRdrug
Tablets
Pramipexole IRdrug
Tablets