Fixed-Dose Trial in Early Parkinson's Disease (TemPo-1)

  • STATUS
    Recruiting
  • participants needed
    522
  • sponsor
    Cerevel Therapeutics, LLC
Updated on 6 December 2022
dopamine
cognitive impairment
dopamine agonists
levodopa
dementia
hallucinations
parkinsonism
tremor
essential tremor
dopa
bradykinesia
impulse control disorder
antiparkinsonian agents
early parkinson's
mao-b inhibitor

Summary

The purpose of this study is to evaluate the clinical efficacy, safety and pharmacokinetics (PK) of 2 fixed doses of tavapadon and placebo in participants with early Parkinson's Disease.

Description

An estimated total of 522 eligible subjects with early Parkinson's Disease, will be randomized to 3 treatment groups.  Subjects will be randomized in a 1:1:1 ratio to receive tavapadon 5 mg, tavapadon 15 mg or placebo.  Each subject will participate in the study for approximately 35 weeks including a 30 day screening period, 27 week treatment period, and 4 week follow-up period.

Subjects may continue to an optional open-label extension period for one year.

Details
Condition Parkinson's disease
Treatment Placebo, Tavapadon
Clinical Study IdentifierNCT04201093
SponsorCerevel Therapeutics, LLC
Last Modified on6 December 2022

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