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

Source: ClinicalTrials.gov results for NCT04201093 (opens in a new tab)· Licence: public-domain

First posted 28 Jul 2025 · Last update posted 28 Jul 2025 · Imported 26 Oct 2026 from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

1. Change From Baseline in the MDS-UPDRS Parts II and III Combined Score

   Time frame

   Week 26

   Measure

   Least squares mean

   Unit

   score on a scale

   • Placebo vs Tavapadon 5 mgSuperiority

     Estimate

     -11.5LS Mean of Difference

     95% CI, two-sided

     -13.8 to -9.2

     p-value

     <0.0001

     Method

     Mixed-effect Model Repeated Measurement

   • Placebo vs Tavapadon 15 mgSuperiority

     Estimate

     -12.1LS Mean of Difference

     95% CI, two-sided

     -14.4 to -9.8

     p-value

     <0.0001

     Method

     Mixed-effect Model Repeated Measurement

Serious adverse events

Time frame: All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.

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.