At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 404 enrolled
Drug / intervention
TVP-1012 1mg +2 moredrug
Likely dose
TVP-1012 1mgfrom 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 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2/3 Study to Evaluate the Efficacy and Safety of TVP-1012 at 0.5 mg or 1 mg in Levodopa Treated Parkinson's Disease Patients With Wearing Off
In Brief
A Phase 3 clinical trial evaluating TVP-1012 1mg, TVP-1012 0.5mg, and 1 other intervention for Parkinson's Disease. Completed, enrolled 404 participants across 57 sites.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of TVP-1012 (0.5 mg or 1 mg/day) as an add-on to levodopa in Japanese participants with Parkinson's disease with wearing-off phenomenon.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 2015
Enrollment StartJan 2015
Primary CompletionSep 2016
TodayJul 2026
First PostedJan 14, 2015
Enrollment StartJan 27, 2015
Primary CompletionSep 17, 2016
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 11.5 years ago
Interventions
TVP-1012 1mgdrug
TVP-1012 1mg Tablets
TVP-1012 0.5mgdrug
TVP-1012 0.5mg Tablets
Placebodrug
Placebo Tablets