Trials / Completed
CompletedNCT04223193
Flexible-Dose Trial in Early Parkinson's Disease (PD)
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 304 (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 efficacy, safety, tolerability and pharmacokinetics (PK) of flexible doses of tavapadon in participants with Parkinson's Disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tavapadon | Participants will be randomized to receive tavapadon 5 mg QD to 15 mg QD tablet once daily orally for 27 weeks. |
| DRUG | Placebo | Participants will receive placebo matching to tavapadon QD orally for 27 weeks. |
Timeline
- Start date
- 2020-01-06
- Primary completion
- 2024-10-01
- Completion
- 2024-10-01
- First posted
- 2020-01-10
- Last updated
- 2025-11-21
- Results posted
- 2025-11-21
Locations
53 sites across 13 countries: United States, Australia, France, Germany, Hungary, Italy, Poland, Serbia, South Korea, Spain, Taiwan, Thailand, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04223193. Inclusion in this directory is not an endorsement.