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

Phase 3 Completed 304 enrolled AbbVie

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2020-01-06
Primary completion: 2024-10-01
Completion: 2024-10-01

Outcome

Met primary endpoint

paper The primary endpoint of change from baseline to week 26 in the MDS-UPDRS Parts II and III combined score was significantly improved with tavapadon versus placebo PMID 42456682 ↗

registry analysis (superiority test); Placebo vs Tavapadon; p <0.0001; LS Mean of Difference -9.1 (95% CI -11.7 to -6.5) NCT04223193 ↗

release “Tavapadon met the primary endpoint in the pivotal Phase 3 TEMPO-2 flexible-dose monotherapy trial” abbvie.com ↗

Publications

Fernandez HH, Bhatia P, Cloud L, Fietzek UM, Matarazzo M, Molho E, Peckham E, Tarakad A, Combs C, Leoni M, Chang I, Tringali S, Boiser J, Sanchez R, Zadikoff C. Safety, tolerability, and efficacy of flexible-dose tavapadon for Parkinson's disease (TEMPO-2): a phase 3, randomised, placebo-controlled, double-blind trial. Lancet Neurol. 2026 Aug;25(8):721-730. doi: 10.1016/S1474-4422(26)00215-2.

Drugs

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