Fixed-Dose Trial in Early Parkinson's Disease (PD)

NCT04201093 ↗

Phase 3 Completed 529 enrolled AbbVie

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2019-12-13
Primary completion: 2024-06-28
Completion: 2024-06-28

Outcome

Met primary endpoint

registry Placebo vs Tavapadon 5 mg; p <0.0001; LS Mean of Difference -11.5 (95% CI -13.8 to -9.2) NCT04201093 ↗

registry Placebo vs Tavapadon 15 mg; p <0.0001; LS Mean of Difference -12.1 (95% CI -14.4 to -9.8) NCT04201093 ↗

paper The change from baseline to week 26 in the MDS-UPDRS parts II and III combined score was significantly improved in participants treated with both the 5-mg dose of tavapadon PMID 41860533 ↗

release “Tavapadon met the primary endpoint in the pivotal Phase 3, TEMPO-1 fixed-dose monotherapy trial” abbvie.com ↗

Publications

Pahwa R, Moro E, Espay AJ, Evans A, Saint-Hilaire M, Torres-Russotto D, Sanchez R, Leoni M, Duvvuri S, Combs C, Chang I, Tringali S, Boiser J, Zadikoff C, Antonini A. Fixed-Dose Tavapadon for Early Parkinson Disease: A Randomized Clinical Trial. JAMA Neurol. 2026 May 1;83(5):452-460. doi: 10.1001/jamaneurol.2026.0590.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tavapadon	Small molecule	5 mg	Oral
Subject	Tavapadon	Small molecule	15 mg	Oral