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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)

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Trial Profile

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 of Trial: Phase III

Latest Information Update: 17 Nov 2025

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At a glance

  • Drugs Tavapadon (Primary)
  • Indications Parkinson's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms TEMPO-1; TEMPO-1 TRIAL
  • Sponsors Cerevel Therapeutics

Most Recent Events

  • 26 Sep 2025 According to Abbvie media release, Submits New Drug Application to U.S. FDA for Tavapadon. The submission is based on results from the TEMPO clinical development program that evaluated the efficacy, safety and tolerability of tavapadon across a broad Parkinson's disease population. This includes two Phase 3 trials (TEMPO-1 and TEMPO-2) in early Parkinson's disease, and one Phase 3 trial (TEMPO-3) and TEMPO-4 study.
  • 26 Sep 2024 According to Abbvie media release, full results from the TEMPO-1 study will be submitted for presentation at future medical meetings and used to support regulatory submissions of tavapadon as a treatment for Parkinson's disease.
  • 26 Sep 2024 Positive topline results presented in an Abbvie media release.

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