Only 137 spots left

~137 spots leftby Oct 2025

CVN424 for Parkinson's Disease

Recruiting in Palo Alto (17 mi)

+25 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Cerevance

Must be taking: Levodopa

Must not be taking: Antipsychotics, Strong CYP3A4/5 inhibitors

Disqualifiers: Atypical parkinsonism, Severe dyskinesias, Heart disease, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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, 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.

Will I have to stop taking my current medications?

The trial requires that your Parkinson's medications be stable for at least 4 weeks before screening, and certain medications like MAO-B inhibitors need to be stable for 12 weeks. You should not be using strong CYP3A4/5 inhibitors or inducers, or medications with dopamine antagonist activity. It's best to discuss your current medications with the study team to see if any changes are needed.

Is CVN424 safe for humans?

In a study with healthy volunteers, CVN424 was generally well tolerated with no serious or severe side effects observed, and no significant changes in vital signs or lab results.¹ ² ³ ⁴ ⁵

Research Team

Eligibility Criteria

This trial is for people with Parkinson's Disease who have motor complications. They must meet specific diagnostic criteria, respond well to levodopa, and experience at least 3 hours of 'OFF' time daily. Participants should be able to walk (with or without help), have a certain cognitive score, maintain stable PD medication use before the trial, and fall within a specified weight range.

Inclusion Criteria

I've been on stable medication for drooling for 30 days without expecting changes.

Average of ≥ 3 h total OFF time/day on Screening home diaries, with at least 2.5 hours OFF on each diary day.

Approved as an appropriate and suitable candidate by the Enrollment Authorization Committee (EAC)

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Exclusion Criteria

I often feel dizzy when standing up and need medication for it.

I experience specific types of movement issues without peak-dose involuntary movements.

Tests positive at Screening for drugs of abuse (opiates, tetrahydrocannabinol [THC], methadone, cocaine, and amphetamines [including ecstasy]).

See 22 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive once-daily oral doses of either 75 mg CVN424, 150 mg CVN424, or a matching placebo for 12 weeks

12 weeks

Regular in-person visits for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1-2 visits (in-person)

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Treatment Details

Interventions

CVN424 (Dopamine Agonist)

Trial OverviewThe study tests CVN424 at two different doses (75 mg and 150 mg) against a placebo in patients with Parkinson's Disease over 12 weeks. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real drug or placebo. Successful candidates may join a future open-label extension study.

Participant Groups

3Treatment groups

Experimental Treatment

Placebo Group

Group I: CVN424 75 mgExperimental Treatment1 Intervention

Participants will be administered with oral doses of 75 mg CVN424.

Group II: CVN424 150 mgExperimental Treatment1 Intervention

Participants will be administered with oral doses of 150 mg CVN424.

Group III: PlaceboPlacebo Group1 Intervention

Participants will be administered with placebo.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cerevance

Lead Sponsor

Trials

Recruited

390+

Findings from Research

CVN424 is a first-in-class small molecule that selectively targets the GPR6 receptor, which is important for controlling movement and is implicated in Parkinson's disease; it was found to be safe and well tolerated in a phase 1 study involving healthy volunteers.

The study demonstrated that CVN424 reached peak plasma concentrations within 2 hours and had a mean half-life of 30 to 41 hours, with no serious adverse effects reported, paving the way for further investigation in a phase 2 study for Parkinson's disease patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase I, First-in-Human, Healthy Volunteer Study to Investigate the Safety, Tolerability, and Pharmacokinetics of CVN424, a Novel G Protein-Coupled Receptor 6 Inverse Agonist for Parkinson's Disease.Margolin, DH., Brice, NL., Davidson, AM., et al.[2022]

CVN424 is a highly potent and selective inverse agonist for the GPR6 receptor, showing promise as a novel treatment for Parkinson's disease by improving motor function in preclinical models.

In animal studies, CVN424 demonstrated brain penetration and dose-dependent effects, including increased locomotor activity and reversal of catalepsy, indicating its potential therapeutic efficacy without relying on traditional dopaminergic pathways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of CVN424: A Selective and Novel GPR6 Inverse Agonist Effective in Models of Parkinson Disease.Brice, NL., Schiffer, HH., Monenschein, H., et al.[2021]

The study developed a selective antagonist, CVN417, targeting the α6 subunit of nicotinic acetylcholine receptors, which is important for modulating dopamine release and may help in treating movement disorders.

In rodent models, CVN417 effectively reduced tremors, suggesting its potential as a therapeutic option for conditions like Parkinson's disease that involve motor dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discovery of CVN417, a Novel Brain-Penetrant α6-Containing Nicotinic Receptor Antagonist for the Modulation of Motor Dysfunction.Christie, LA., Brice, NL., Rowland, A., et al.[2023]