Phase 3 Study of CVN424
Research type
Research Study
Full title
Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of CVN424 in Parkinson’s Disease Patients with Motor Complications
IRAS ID
1012718
Contact name
Celina Scholl
Contact email
Sponsor organisation
Cerevance Beta, Inc.
Clinicaltrials.gov Identifier
Research summary
Cerevance Beta, Inc. is running a research study to see if a test medicine not yet approved for market, named CVN424, will help in the treatment of Parkinson’s Disease (PD) and how safe it is.
The primary objective of the trial is to assess the effectiveness of CVN424 taken once a day compared to placebo (which looks like CVN424 but does not have any medicine in it), for change in the amount of daily OFF time (periods when the effects of Parkinson’s medication wear off and PD symptoms return or worsen) in people with PD.
This study will include up to about 330 men and women with PD. Participants will be at least 30 years old when they join this study. Patients will have stable dosages of PD medication (levodopa) with an average of ≥3 hours or more of total OFF time per day. Patients with diagnosis of secondary or atypical parkinsonism cannot participate in this study.
Participants are expected to be in this study for up to 5 months. During this time, they will attend the study site for visits up to 8 times, on Day 1 and weeks 2, 4, 8, 12, 14, and have phone calls at week 1, 3, 6 and 10.
This will be a randomised, “double-blind” study, which means the participants and study staff will not know which study drug the participants receive. Participants will be randomised (assigned by chance, like flipping a coin) to a treatment group and will have a 1 in 3 chance of receiving placebo and a 2 in 3 chance of receiving CVN424 (75 mg or 150 mg dose). They will take the study drug in the form of a tablet themselves, orally, once a day, over the course of 12 weeks. Participants will be monitored for an additional 2 weeks after they finish taking the study drug.
Study staff will check participants’ overall health throughout the study, take blood and urine samples and perform an electrocardiograph (ECG). They will use questionnaires to check how the participants’ PD is affecting daily activities. Participants will also complete diaries and questionnaires by themselves.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
25/NE/0198
Date of REC Opinion
18 Nov 2025
REC opinion
Further Information Favourable Opinion