Trials / Completed
CompletedNCT04542499
Flexible-Dose, Adjunctive Therapy Trial in Adults With Parkinson's Disease With Motor Fluctuations (TEMPO-3)
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 507 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tavapadon | Participants will be randomized to receive tavapadon 5 to 15 mg tablet QD orally for 27 weeks. |
| DRUG | Placebo | Participants will receive placebo matching to tavapadon QD orally for 27 weeks. |
Timeline
- Start date
- 2020-09-23
- Primary completion
- 2024-01-29
- Completion
- 2024-02-15
- First posted
- 2020-09-09
- Last updated
- 2025-04-04
- Results posted
- 2025-03-25
Locations
146 sites across 14 countries: United States, Australia, Bulgaria, Canada, Czechia, France, Germany, Hungary, Israel, Italy, Poland, Serbia, Spain, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04542499. Inclusion in this directory is not an endorsement.