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Trials / Active Not Recruiting

Active Not RecruitingNCT06553027

To Evaluate the Efficacy of CVN424 in Parkinson's Disease Participants With Motor Complications

Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of CVN424 in Parkinson's Disease Patients With Motor Complications

Status
Active Not Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
330 (estimated)
Sponsor
Cerevance · Industry
Sex
All
Age
30 Years
Healthy volunteers
Not accepted

Summary

This is a randomized, double-blind, placebo-controlled, multicenter study in participants with Parkinson's disease (PD) with motor fluctuations. Participants will be randomized to receive once-daily oral doses of either 75 milligrams (mg) CVN424 or 150 mg CVN424, or a matching placebo for 12 weeks. Participants who successfully complete this study and retain eligibility/suitability will be invited to participate in a future open-label extension (OLE) study.

Conditions

Interventions

TypeNameDescription
DRUGCVN424 75 mgParticipants will receive 75 mg CVN424 tablet once daily.
DRUGCVN424 150 mgParticipants will receive 150 mg CVN424 tablet once daily.
DRUGPlaceboParticipants will receive matching placebo tablet once daily.

Timeline

Start date
2024-09-20
Primary completion
2026-08-01
Completion
2026-08-01
First posted
2024-08-14
Last updated
2026-04-17

Locations

94 sites across 9 countries: United States, Australia, Czechia, France, Italy, Poland, Puerto Rico, Spain, United Kingdom

Regulatory

Source: ClinicalTrials.gov record NCT06553027. Inclusion in this directory is not an endorsement.