Trials / Completed
CompletedNCT04201093
Fixed-Dose Trial in Early Parkinson's Disease (PD)
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 529 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tavapadon | Participants will be randomized to receive tavapadon 5mg tablet once daily orally for 27 weeks. |
| DRUG | Placebo | Participants will receive placebo matching to tavapadon QD orally for 27 weeks. |
| DRUG | Tavapadon | Participants will be randomized to receive tavapadon 15mg tablet once daily orally for 27 weeks. |
Timeline
- Start date
- 2019-12-13
- Primary completion
- 2024-06-28
- Completion
- 2024-06-28
- First posted
- 2019-12-17
- Last updated
- 2025-07-28
- Results posted
- 2025-07-28
Locations
77 sites across 12 countries: United States, Australia, Bulgaria, Canada, Czechia, France, Germany, Israel, Italy, Poland, Spain, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04201093. Inclusion in this directory is not an endorsement.