CVN424 Monotherapy for Early Parkinson's Disease

Recruiting at 49 trial locations

Overseen By Shabbir Hussain Idris Merchant, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Cerevance Beta, Inc.

Must not be taking: Antipsychotics, Metoclopramide, Reserpine, others

Disqualifiers: Atypical parkinsonism, Heart disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

62 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a multicenter, 12-week, placebo-controlled clinical trial of CVN424 150 milligrams (mg) tablets in early, untreated Parkinson's Disease (PD). Participants will be randomized in a 1:1 ratio to CVN424 150 mg or placebo at the Baseline Visit. The purpose of this study is to measure effect on motor features with CVN424 tablets compared to placebo in early, untreated PD and to evaluate the potential of CVN424 to improve motor and non-motor functions in participants with early PD who are not taking dopaminergic or anti-PD therapies.

Eligibility Criteria

This trial is for adults over 30 with early, untreated Parkinson's Disease who can walk (with or without help) and have mild to moderate disease severity. They shouldn't need Parkinson's medication during the study and must use reliable contraception if applicable. People with previous PD surgery, certain medical conditions, or recent use of specific drugs cannot join.

Inclusion Criteria

I have been diagnosed with Parkinson's disease, showing slow movement and motor asymmetry.

I am not on Parkinson's disease medication and don't expect to need it soon.

I am 30 years old or older.

Exclusion Criteria

I have not used marijuana in the last 2 months and will not use CBD during the study.

I experience significant dizziness when standing up.

Positive test for coronavirus disease 2019 (COVID-19). Confirmatory test will be allowed at the discretion of the Investigator to rule out false positives. A participant who tests positive for COVID-19 will be eligible to be rescreened once result is negative

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CVN424 150 mg or placebo for 12 weeks to evaluate effects on motor and non-motor functions in early Parkinson's Disease

12 weeks

Baseline visit and regular assessments up to Week 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CVN424

Trial Overview The trial tests CVN424 (150 mg), a potential new treatment for Parkinson’s Disease symptoms against a placebo in patients not on other PD therapies. It aims to see if CVN424 improves motor and non-motor functions over 12 weeks compared to no active treatment.

Participant Groups

Group I: CVN424 150 mg Experimental Treatment 1 Intervention

Participants will be administered with CVN424 150 mg.

Group II: Placebo Placebo Group 1 Intervention

Participants will be administered with placebo.

Who Is Running the Clinical Trial?

Cerevance Beta, Inc.

Lead Sponsor

Trials

4

Recruited

290+