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CVN424 Monotherapy for Early Parkinson's Disease

Phase 2

Recruiting

Research Sponsored by Cerevance Beta, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-dose (0 h) and at 4 h post-dose on day 1, week 4, 8, and 12

Awards & highlights

Study Summary

This trial evaluates the effects of a drug (CVN424) on motor and non-motor functions in people with early Parkinson's Disease who are not taking medications.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Specific side effects of CVN424 are not listed here but generally could include typical drug reactions such as nausea, dizziness, sleep disturbances or other unexpected health issues that will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose (0 h) and at 4 h post-dose on day 1, week 4, 8, and 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-dose (0 h) and at 4 h post-dose on day 1, week 4, 8, and 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose (0 h) and at 4 h post-dose on day 1, week 4, 8, and 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline to Week 12 on the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III

Secondary outcome measures

Change from Baseline on the Epworth Sleepiness Scale (ESS)

Change from Baseline on the Non-motor Symptoms Scale (NMSS)

Change from Baseline on the Parkinson's Disease Sleep Scale (PDSS-2)

+12 more

Other outcome measures

Change from Baseline to Week 12 on the CogState digital cognitive battery

Change from Baseline to Week 12 on the Electroencephalogram (EEG) derived sleep metrics

Change from Baseline to Week 12 on the Modality Virtual Assessment

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CVN424 150 mgExperimental Treatment1 Intervention

Participants will be administered with CVN424 150 mg.

Group II: PlaceboPlacebo Group1 Intervention

Participants will be administered with placebo.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Cerevance Beta, Inc.Lead Sponsor

3 Previous Clinical Trials

237 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you explain the potential hazards associated with CVN424 150 mg consumption?

"Based on our assessments, CVN424 150 mg has been rated a 2 due to the presence of safety data but lack of efficacy evidence in its Phase 2 clinical trials."

Answered by AI

Are there any opportunities to sign up for this research study at present?

"Affirmative. Clinicaltrials.gov documents that this medical research, which was originally published on September 11th 2023, is actively recruiting participants. 60 individuals between two sites are needed for the trial to be complete."

Answered by AI

How many participants have registered for the trial?

"Correct. According to the records on clinicaltrials.gov, this medical study is currently enrolling participants, having been initially posted on September 11th of 2023 and last edited on October 18th of 2023. The trial seeks 60 candidates from 2 sites in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Early Parkinson's Disease Monotherapy With CVN424

2023. "Early Parkinson's Disease Monotherapy With CVN424". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06006247.

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