TerminatedPhase 2

An Open-label Extension Trial of CVL-865 as Adjunctive Therapy in the Treatment of Focal Onset Seizures

Stopped: Closed early after CVL-865-SZ-001 (NCT04244175) did not meet its primary objective

United States, Australia, Poland105 participantsStarted 2020-12-08

Plain-language summary

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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants who completed treatment in Trial CVL-865-SZ-001 (NCT04244175) * A female participant of childbearing potential who is sexually active with a nonsterilized male partner must agree to use a highly effective method of contraception from signing of informed consent through 30 days post last dose * A male participant with a pregnant or a nonpregnant partner of childbearing potential must agree to use a condom during treatment and until the end of relevant systemic exposure in the male participant for 94 days following the last dose with the investigational medicinal product (IMP) * Participants who are capable of giving signed informed consent * Participants who are able, in the opinion of the investigator, to understand the nature of the trial and comply with protocol requirements, including the prescribed dosage regimens, scheduled visits, laboratory tests, and other trial procedures Exclusion Criteria: * Participants who, in the opinion of the investigator, medical monitor, or sponsor, should not participate in the trial * Participants who, in the judgment of the investigator, experienced poor tolerability to the IMP during the double-blind trial or whose safety assessments resulted in new concerns that would suggest that the participant may not be appropriate for 57 weeks of treatment with CVL-865 in an extension trial * Participants who experienced status epilepticus during Trial CVL-865-SZ-001 * Participants who have demonstrated substan…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Treatment Emergent Adverse Event (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

Timeframe: From first dose of study drug up to Week 61

Number of Participants With Clinically Significant Changes From Baseline in Electrocardiogram (ECGs)

Timeframe: Baseline up to Week 57

Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Measurements

Timeframe: Baseline up to Week 57

Number of Participants With Clinically Significant Changes From Baseline in Physical and Neurological Examination Results

Timeframe: Baseline up to Week 57

Suicidality Based on the Columbia Suicide-Severity Rating Scale (C-SSRS)

Timeframe: Baseline up to Week 61

Change From End of Treatment in Modified Clinical Institute Withdrawal Assessment - Benzodiazepines (mCIWA-B) Score at the End of Post-treatment Follow-up (Week 61)

Timeframe: Week 57, Week 61

Trial details

NCT IDNCT04686786

SponsorAbbVie

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-05

Results submitted2025-11-26

View on ClinicalTrials.gov More Seizures trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Treatment Emergent Adverse Event (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

Timeframe: From first dose of study drug up to Week 61

Number of Participants With Clinically Significant Changes From Baseline in Electrocardiogram (ECGs)

Timeframe: Baseline up to Week 57

Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Measurements

Timeframe: Baseline up to Week 57

Number of Participants With Clinically Significant Changes From Baseline in Physical and Neurological Examination Results

Timeframe: Baseline up to Week 57

Suicidality Based on the Columbia Suicide-Severity Rating Scale (C-SSRS)

Timeframe: Baseline up to Week 61

Change From End of Treatment in Modified Clinical Institute Withdrawal Assessment - Benzodiazepines (mCIWA-B) Score at the End of Post-treatment Follow-up (Week 61)

Timeframe: Week 57, Week 61