CVL-865 for Seizures

Recruiting at 73 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Cerevel Therapeutics, LLC

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: Unknown

154 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called CVL-865 for people whose seizures are not controlled by current treatments. The medication works by balancing brain activity to help reduce seizures. CVL-865 is one of the newer antiepileptic drugs with a novel mode of action compared to more established treatments.

Research Team

Eliza Hueda, MD

Principal Investigator

Cerevel Therapeutics, LLC

Eligibility Criteria

This trial is for adults with drug-resistant focal onset seizures, who've tried at least two anti-epileptic drugs without success and are currently on 1 to 3 stable AEDs. They must have had a minimum of eight seizures in the last eight weeks and been diagnosed with epilepsy for at least two years. Participants need a BMI between 17.5 to 40 kg/m^2 and weigh over 50 kg.

Inclusion Criteria

I agree to use a condom for 94 days after my last dose of the trial medication.

I have been diagnosed with focal epilepsy for at least 2 years.

I have tried at least 2 epilepsy drugs without success and am currently on 1 to 3 stable epilepsy drugs.

Exclusion Criteria

I am not currently using, nor likely to use, any medications not allowed by the study.

Your heart's electrical activity measured by ECG shows specific patterns that are too long.

I have trouble swallowing.

Treatment Details

Interventions

• CVL-865
• Placebo

Trial Overview The study tests CVL-865 as an additional treatment against placebo in people with focal onset seizures that don't respond well to other medications. The goal is to see if CVL-865 can reduce seizure frequency safely and tolerably.

Participant Groups

Group I: Low Dose: CVL-865 7.5 mg Experimental Treatment 1 Intervention

Participants will receive CVL-865 tablets orally BID up to the maximum dose of 7.5 mg until Day 92 during the treatment period.

Group II: High Dose: CVL-865 25 mg Experimental Treatment 1 Intervention

Participants will receive CVL-865 tablets orally twice daily (BID) up to the maximum dose of 25 milligrams (mg) until Day 92 during the treatment period.

Group III: Placebo Placebo Group 1 Intervention

Participants will receive a placebo matched to CVL-865 tablets orally BID until Day 92 during the treatment period.

Who Is Running the Clinical Trial?

Cerevel Therapeutics, LLC

Lead Sponsor

Trials

37

Recruited

5,500+