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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)

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Trial Profile

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 of Trial: Phase III

Latest Information Update: 09 Dec 2025

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At a glance

  • Drugs Tavapadon (Primary)
  • Indications Parkinson's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms TEMPO-2
  • 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.
  • 09 Dec 2024 According to Abbvie media release, Full results from the TEMPO-2 trial will be submitted for presentation at a future medical meeting.
  • 09 Dec 2024 According to Abbvie media release, Primary endpoint (Change From Baseline in the Movement Disorder Society - Unified Parkinsons Disease Rating Scale (MDS-UPDRS) Parts II and III Combined Score) has been met.

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