At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 507 enrolled
Drug / intervention
Tavapadon +1 moredrug
Likely dose
Tavapadon 15 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.
A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson's Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial)
In Brief
A Phase 3 clinical trial evaluating Tavapadon and Placebo for Parkinson Disease. Completed, enrolled 507 participants across 146 sites in 14 countries.
Detailed Summary
The purpose of this study is to assess the effect of tavapadon on the change from baseline in total daily hours of "on" time without troublesome dyskinesia in L-Dopa-treated participants with Parkinson's Disease (PD) who are experiencing motor fluctuations.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson Disease
CountriesAustralia, Bulgaria, Canada, Czechia, France, Germany, Hungary, Israel, Italy, Poland, Serbia, Spain, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedSep 2020
Enrollment StartSep 2020
Primary CompletionJan 2024
Study CompletionFeb 2024
TodayJul 2026
First PostedSep 9, 2020
Enrollment StartSep 23, 2020
Primary CompletionJan 29, 2024
Study CompletionFeb 15, 2024
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 5.8 years ago
Interventions
Tavapadondrug
Participants will be randomized to receive tavapadon 5 to 15 mg tablet QD orally for 27 weeks.
Placebodrug
Participants will receive placebo matching to tavapadon QD orally for 27 weeks.