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

NCT04223193 · TEMPO-2 Phase 3Completed

Lead sponsor
AbbVie (Industry)
Enrollment
304 (actual)
Start date
6 Jan 2020
Primary completion
1 Oct 2024 (actual)
Study completion
1 Oct 2024
Last update posted
21 Nov 2025

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
Double
Arms
2

Interventions

  • Tavapadon Drug
  • Placebo Drug

Conditions and primary outcome

  • Parkinson Disease

Primary outcome

Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III Combined Score (Week 26)

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT04223193 (opens in a new tab)· Licence: public-domain

First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

  1. Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III Combined Score

    Time frame
    Week 26
    Measure
    Least squares mean
    Unit
    score on a scale

    • Placebo vs TavapadonSuperiority

      Estimate
      -9.1LS Mean of Difference
      95% CI, two-sided
      -11.7 to -6.5
      p-value
      <0.0001
      Method
      Mixed-effect Model Repeated Measurement

Serious adverse events

Time frame: All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.

Participants with serious adverse events per group for TEMPO-2, as posted
GroupAffectedAt risk
Placebo2153
Tavapadon7151

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

1 on PubMed

  1. Safety, tolerability, and efficacy of flexible-dose tavapadon for Parkinson's disease (TEMPO-2): a phase 3, randomised, placebo-controlled, double-blind trial.

    The Lancet. Neurology · 2026 Aug

    PubMed 42456682 (opens in a new tab)DOI 10.1016/S1474-4422(26)00215-2 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

CT-VCA trial quality

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Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Nothing on this page is medical or investment advice.