At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 529 enrolled
Drug / intervention
Tavapadon +2 moredrug
Likely dose
Tavapadon 5mgfrom 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, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses of Tavapadon in Early Parkinson's Disease (TEMPO-1 TRIAL)
In Brief
A Phase 3 clinical trial evaluating Tavapadon and Placebo for Parkinson Disease. Completed, enrolled 529 participants across 77 sites in 12 countries.
Detailed Summary
The purpose of this study is to evaluate the clinical efficacy, safety and pharmacokinetics (PK) of 2 fixed doses of tavapadon and placebo in participants with early PD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson Disease
CountriesAustralia, Bulgaria, Canada, Czechia, France, Germany, Israel, Italy, Poland, Spain, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
Enrollment StartDec 2019
First PostedDec 2019
Primary CompletionJun 2024
TodayJul 2026
First PostedDec 17, 2019
Enrollment StartDec 13, 2019
Primary CompletionJun 28, 2024
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 6.5 years ago
Interventions
Tavapadondrug
Participants will be randomized to receive tavapadon 5mg tablet once daily orally for 27 weeks.
Placebodrug
Participants will receive placebo matching to tavapadon QD orally for 27 weeks.
Tavapadondrug
Participants will be randomized to receive tavapadon 15mg tablet once daily orally for 27 weeks.