At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 304 enrolled
Drug / intervention
Tavapadon +1 moredrug
Likely dose
Tavapadon 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.
A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon in Early Parkinson's Disease (TEMPO-2 Trial)
In Brief
A Phase 3 clinical trial evaluating Tavapadon and Placebo for Parkinson Disease. Completed, enrolled 304 participants across 53 sites in 13 countries.
Detailed Summary
The purpose of this study is to assess the efficacy, safety, tolerability and pharmacokinetics (PK) of flexible doses of tavapadon in participants with Parkinson's Disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson Disease
CountriesAustralia, France, Germany, Hungary, Italy, Poland, Serbia, South Korea, Spain, Taiwan, Thailand, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
Enrollment StartJan 2020
First PostedJan 2020
Primary CompletionOct 2024
TodayJul 2026
First PostedJan 10, 2020
Enrollment StartJan 6, 2020
Primary CompletionOct 1, 2024
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 6.5 years ago
Interventions
Tavapadondrug
Participants will be randomized to receive tavapadon 5 mg QD to 15 mg QD tablet once daily orally for 27 weeks.
Placebodrug
Participants will receive placebo matching to tavapadon QD orally for 27 weeks.