CVL-865 for Seizures

Recruiting at 73 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Cerevel Therapeutics, LLC

Must be taking: Antiepileptic drugs

Must not be taking: P-gp, BCRP substrates

Disqualifiers: Generalized epilepsy, High-frequency seizures, others

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: 1

Duration: 13 weeks

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.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it mentions that participants should be on 1 to 3 permitted anti-epileptic drugs at a stable dose before starting. Some medications might be prohibited, so it's best to discuss your current medications with the trial team.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CVL-865 or placebo tablets orally twice daily until Day 92

13 weeks

Regular visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1-2 visits (in-person or virtual)

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+