CVL-865 for Seizures

Recruiting at 53 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AbbVie

Disqualifiers: Status epilepticus, Noncompliance, Suicide risk, others

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

Duration: 57 weeks

105 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess the long-term safety and tolerability of CVL-865 as adjunctive therapy in participants with focal onset seizures.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for individuals who have focal onset seizures and completed treatment in a prior related trial (CVL-865-SZ-001). They must be able to follow the study plan, use effective contraception if of childbearing potential, and not have had severe reactions or poor tolerance to CVL-865 previously. Those with certain blood abnormalities, at risk of suicide, or needing prohibited medications can't join.

Inclusion Criteria

I understand the trial's requirements and believe I can follow them.

I agree to use effective birth control during and for 30 days after the trial.

I am able to understand and sign the consent form.

Exclusion Criteria

I won't need medications that aren't allowed in the trial.

Participants who have demonstrated substantial noncompliance to trial procedures in Trial CVL-865-SZ-001, based on the investigator's judgment, would not be eligible for this trial

You had a seizure during Trial CVL-865-SZ-001.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CVL-865 tablets orally twice daily up to a maximum dose of 25 mg until Week 57

57 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants continue to receive CVL-865 as adjunctive therapy to assess long-term safety and tolerability

Long-term

Treatment Details

Interventions

• CVL-865

Trial Overview The trial is testing the long-term safety and effectiveness of a drug called CVL-865 when used alongside other treatments for seizures. Participants will receive this medication over an extended period to monitor how well it works and any side effects that occur over time.

Participant Groups

Group I: 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 Week 57 during the treatment period.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Cerevel Therapeutics, LLC

Lead Sponsor

Trials

37

Recruited

5,500+