CVN424 Monotherapy for Early Parkinson's Disease

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called CVN424 for individuals with early Parkinson's disease who have not yet started any other Parkinson's treatments. The goal is to determine how well CVN424 improves both motor (movement-related) and non-motor symptoms compared to a placebo (a pill with no active drug). Participants will be randomly assigned to receive either CVN424 or a placebo for 12 weeks to compare the effects. This trial suits those diagnosed with early Parkinson's who are not currently taking Parkinson's medications. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

Yes, you will need to stop taking certain medications to join this trial. Participants cannot be on any anti-parkinsonian therapy, and there are specific restrictions on medications like dopamine agonists, MAOB inhibitors, antipsychotics, and others. Make sure to discuss your current medications with the trial team to see if they are allowed.

Is there any evidence suggesting that CVN424 is likely to be safe for humans?

Research has shown that CVN424 is generally safe and well tolerated. In previous studies with healthy adults, no serious or severe side effects occurred. Participants experienced no major changes in vital signs, such as heart rate or blood pressure. This suggests that CVN424 is likely well-tolerated in individuals with early Parkinson's Disease, although ongoing studies will provide more specific information for this group. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Parkinson's Disease?

Unlike the standard treatments for early Parkinson's disease, which often include medications like Levodopa that increase dopamine levels, CVN424 works differently by targeting a protein called the GPR6 receptor. This unique mechanism could potentially offer a more direct way to manage symptoms without the fluctuations and side effects associated with dopamine-based therapies. Researchers are excited about CVN424 because it represents a novel approach, possibly leading to more stable symptom control and improved quality of life for patients with fewer side effects.

What evidence suggests that CVN424 might be an effective treatment for early Parkinson's Disease?

Research shows that CVN424, a new type of medication, may help treat Parkinson's disease (PD). Animal studies have demonstrated that CVN424 can improve movement problems similar to those seen in PD. In earlier studies with people, participants taking CVN424 reported feeling more alert during the day, a common challenge for those with PD. Overall, these findings suggest that CVN424 might help with both movement and alertness in the early stages of PD. Participants in this trial will receive either CVN424 or a placebo to further evaluate its effectiveness. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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.

My Parkinson's disease is in the early to mid-stage.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00461-9/fulltext

CVN424, a GPR6 inverse agonist, for Parkinson's disease ... Preclinical studies demonstrate that CVN424 is effective in reversing locomotor deficits in animal models of PD, and a phase 1 study showed that ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06006247

Early Parkinson's Disease Monotherapy With CVN424 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 ...

3. cerevance.com cerevance.com/studies/cvn424

CVN424 The ASCEND clinical study is evaluating whether CVN424, an investigational drug, is safe and effective in improving the motor and non-motor symptoms of ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06553027

To Evaluate the Efficacy of CVN424 in Parkinson's Disease ... This is a randomized, double-blind, placebo-controlled, multicenter study in participants with Parkinson's disease (PD) with motor fluctuations.

5. davisphinneyfoundation.org davisphinneyfoundation.org/blog/clinical-trial-cvn424/

The ASCEND Clinical Trial Explores Novel Target in ... The results showed that participants taking 150 mg/day of CVN424, experienced improvement of daytime alertness. Design of the CVN424-203 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35110393/

A Phase I, First-in-Human, Healthy Volunteer Study to ... CVN424 was generally well tolerated: no serious or severe adverse effects were observed, and there were no clinically significant changes in ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022356524002544

A Phase I, First-in-Human, Healthy Volunteer Study to ... CVN424 was generally well tolerated: no serious or severe adverse effects were observed, and there were no clinically significant changes in vital signs or ...

8. neurology.org neurology.org/doi/10.1212/WNL.0000000000210649

Solengepras (CVN424): A Novel GPR6 Inhibitor in Clinical ... ASCEND is a randomized, double-blind, placebo-controlled study of 62 participants with early PD who are naïve to dopaminergic therapy.