CVL-865 for Seizures

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
SeizuresCVL-865 - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
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Study Summary

This trial will test if CVL-865 is an effective, safe, and tolerable treatment for people with drug-resistant focal onset seizures.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 16 Secondary · Reporting Duration: Day 15, Day 43, Day 71, Day 92 and/or early termination (ET)

Day 92
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECGs)
Day 92
Number of Participants with Clinically Significant Changes in Physical and Neurological Examination Results
Number of Participants with Clinically Significant Changes in Vital Sign Measurements
Day 71
Change From Baseline in Focal Onset Seizure Frequency per Week over the Maintenance Phase
Percentage of Seizure-free Participants
Seizure Rate over Time
Day 15
Change From Baseline in Clinical Global Impression-Improvement Scale (CGI-I) Score at Day 15, 43 and 71
Change from Baseline in Clinical Global Impression-Severity of Symptoms Scale (CGI-S) Score at Day 15, 43 and 71
Patient's Global Impression of Change (PGIC) Score at Days 15, 43 and 71
Baseline, Day 71
Change from Baseline in Health Utilities Index (HUI) Utility Score at Day 71
Change from Baseline in Quality of Life in Epilepsy -31 (QOLIE-31) Overall Score at Day 71
Day 92
Plasma Concentrations of CVL-865
Day 71
Percentage of Participants with 50 Percent (%) Responder Rate
Response Ratio (RRatio)
Day 120
Number of Participants with Positive Response to Modified Clinical Institute Withdrawal Assessment - Benzodiazepines (mCIWA-B)
Day 120
Number of Participants With Positive Response to Columbia Suicide-Severity Rating Scale (C-SSRS)
Number of Participants With Treatment Emergent Adverse Event (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

High Dose: CVL-865 25 mg
1 of 3
Low Dose: CVL-865 7.5 mg
1 of 3
Placebo
1 of 3

Experimental Treatment

Non-Treatment Group

150 Total Participants · 3 Treatment Groups

Primary Treatment: CVL-865 · Has Placebo Group · Phase 2

High Dose: CVL-865 25 mg
Drug
Experimental Group · 1 Intervention: CVL-865 · Intervention Types: Drug
Low Dose: CVL-865 7.5 mg
Drug
Experimental Group · 1 Intervention: CVL-865 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 15, day 43, day 71, day 92 and/or early termination (et)

Who is running the clinical trial?

Cerevel Therapeutics, LLCLead Sponsor
26 Previous Clinical Trials
4,290 Total Patients Enrolled
1 Trials studying Seizures
120 Patients Enrolled for Seizures
Ann Dandurand, MDStudy DirectorCerevel Therapeutics, LLC
4 Previous Clinical Trials
319 Total Patients Enrolled
1 Trials studying Seizures
120 Patients Enrolled for Seizures

Eligibility Criteria

Age 18 - 75 · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have focal aware, focal impaired awareness, or focal to bilateral tonic-clonic seizures during the 8 week baseline period with no 21-day period free of any of these seizure types.
Participants must have had magnetic resonance imaging or contrast enhanced computed tomography scan of the brain that demonstrated no progressive structural central nervous system abnormality at the time of the diagnosis of epilepsy.
Male must agree to use condom during treatment and until the end of relevant systemic exposure in the male participant for 94 days following the last dose with IMP.
You are taking 1 to 3 permitted AEDs at a stable dose for 4 weeks prior to the Screening Visit.
You must have a body mass index (BMI) of 17.5 to 40.
You are a woman of childbearing potential who agrees to use an effective method of contraception from signing of informed consent throughout the duration of the study and for 30 days post last dose.