Flexible-Dose, Adjunctive Therapy Trial in Adults With Parkinson's Disease With Motor Fluctuations (TEMPO-3)

Phase 3 Completed 507 enrolled AbbVie

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2020-09-23
Primary completion: 2024-01-29
Completion: 2024-02-15

Outcome

Met primary endpoint

paper Tavapadon significantly increased daily good-on-time by 1.10 hours compared with placebo (1.70 vs 0.60 hours; 95% CI, 0.60-1.70; P <.001). PMID 41860544 ↗

registry analysis (superiority test); Placebo vs Tavapadon; p <0.0001; LS Mean of Difference 1.103 (95% CI 0.553 to 1.653) NCT04542499 ↗

release “Tavapadon met the primary endpoint in the pivotal Phase 3 TEMPO-3 adjunctive trial” abbvie.com ↗

Publications

Fernandez HH, Isaacson SH, Hauser RA, Agarwal P, Ondo W, Park A, Kremens D, Leoni M, Duvvuri S, Combs C, Koenig E, Chang I, Pastino G, Tringali S, Golonski N, Sanchez R, Harmer L, Boiser J, Zadikoff C, Mari Z. Tavapadon as Adjunctive Treatment for Parkinson Disease: The TEMPO-3 Randomized Clinical Trial. JAMA Neurol. 2026 May 1;83(5):442-451. doi: 10.1001/jamaneurol.2026.0577.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tavapadon	Small molecule	—	—