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Seizure drug study ends early – safety results awaited

NCT ID NCT04686786

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at the long-term safety of an experimental drug called CVL-865 in adults whose focal seizures were not controlled by other medications. About 105 people who completed a previous trial took CVL-865 alongside their usual seizure drugs for up to 57 weeks. The study was stopped early, and researchers tracked side effects, heart changes, and withdrawal symptoms.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

105 people

The number who actually took part.

Started

Dec 2020

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 substantial noncompliance to trial procedures in Trial CVL-865-SZ-001, based on the investigator's judgment, would not be eligible for this trial * Participants who answer "yes" on the C-SSRS Suicidal Ideation Item 4 or Item 5 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan, or Active Suicidal Ideation with Specific Plan and Intent), or participants who answer "yes" on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior), or participants who, in the opinion of the investigator, present a serious risk of suicide * Participants with any of the following abnormalities in clinical laboratory tests at Visit 1, as assessed by the central laboratory and confirmed by a single repeat measurement, if deemed necessary (Females: Hemoglobin \<11 gram per deciliter (g/dL); Males: hemoglobin \<12 g/dL; White blood cell (WBC) count \<3.0 x 10 power 9 per liter (10\^9/L); Neutrophil count \<2.0 x 10\^9/L; Platelet count \<150 × 10\^9/L) * Participants who would be likely to require the use of prohibited concomitant medications during the trial * Female participants who have a positive pregnancy test result

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Conditions

The condition(s) this trial relates to.

epilepsy focal epilepsy visual epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Seizures

Contacts and locations

Locations

  • Baltimore, Maryland

    Baltimore, Maryland, 21287, United States

  • Barcelona, Catalonia

    Barcelona, Catalonia, 08035, Spain

  • Barcelona, Catalunya

    Barcelona, Catalonia, 08003, Spain

  • Bethesda, Maryland

    Bethesda, Maryland, 20817, United States

  • Białystok

    Bialystok, 15-704, Poland

  • Boston, Massachusetts

    Boston, Massachusetts, 02114, United States

  • Bydgoszcz, Kujawsko-Pomorskie

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-163, Poland

  • Camperdown, New South Wales

    Camperdown, New South Wales, 2050, Australia

  • Charleston, South Carolina

    Charleston, South Carolina, 29425, United States

  • Chesterfield, Missouri

    Chesterfield, Missouri, 63005, United States

  • Fitzroy, Victoria

    Fitzroy, Victoria, 3065, Australia

  • Gdańsk, Pomorskie

    Gdansk, Pomeranian Voivodeship, 80-803, Poland

  • Gulf Breeze, Florida

    Gulf Breeze, Florida, 32561-4458, United States

  • Gwangjin-gu, Seoul

    Gwangju, Seoul, 05030, South Korea

  • Hackensack, New Jersey

    Hackensack, New Jersey, 07601, United States

  • Heidelberg, Victoria

    Heidelberg, Victoria, 3084, Australia

  • Herston, Queensland

    Herston, Queensland, 4029, Australia

  • Honolulu, Hawaii

    Honolulu, Hawaii, 96817, United States

  • Irwon-Ro Gangnam-gu., Seoul

    Irwon-dong, Seoul, 06351, South Korea

  • Jacksonville, Florida

    Jacksonville, Florida, 32224, United States

  • Kragujevac, Sumadija

    Kragujevac, Sumadija, 34000, Serbia

  • Kraków, Malopolskie

    Krakow, Lesser Poland Voivodeship, 31-209, Poland

  • Kyiv

    Kyiv, 02091, Ukraine

  • Lexington, Kentucky

    Lexington, Kentucky, 40504, United States

  • Little Rock, Arkansas

    Little Rock, Arkansas, 72205, United States

  • Lodz

    Lodz, Łódź Voivodeship, 90-752, Poland

  • Lviv

    Lviv, 79035, Ukraine

  • Madrid

    Madrid, 28034, Spain

  • Madrid

    Madrid, 28040, Spain

  • Malaga,

    Málaga, Andalusia, 29010, Spain

  • Melbourne, Victoria

    Melbourne, Victoria, 3004, Australia

  • Miami Lakes, Florida

    Miami Lakes, Florida, 33016, United States

  • Nashville, Tennessee

    Nashville, Tennessee, 37232, United States

  • Neurology Department, Kragujevac

    Kragujevac, Sumadija, 34000, Serbia

  • New Haven, Connecticut

    New Haven, Connecticut, 06519, United States

  • New York

    New York, New York, 10021, United States

  • Oklahoma City, Oklahoma

    Oklahoma City, Oklahoma, 73112, United States

  • Orlando, Florida

    Orlando, Florida, 32806, United States

  • Parkville, Victoria

    Parkville, Victoria, 3050, Australia

  • Philadelphia, Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Philadelphia, Pennsylvania

    Philadelphia, Pennsylvania, 19107, United States

  • Port Charlotte, Florida

    Port Charlotte, Florida, 33952, United States

  • Randwick, New South Wales

    Randwick, New South Wales, 2031, Australia

  • Rochester, New York

    Rochester, New York, 14642, United States

  • Saint Louis, Missouri

    St Louis, Missouri, 63110, United States

  • Salt Lake City, Utah

    Salt Lake City, Utah, 84132, United States

  • Scarborough, Maine

    Scarborough, Maine, 04074, United States

  • Sevilla

    Seville, 41013, Spain

  • Tampa, Florida

    Tampa, Florida, 33606, United States

  • Terrassa, Catalonia

    Terrassa, Catalonia, 08222, Spain

  • Toledo, Ohio

    Toledo, Ohio, 43614, United States

  • Uzhgorod

    Uzhhorod, Uzhgorod, 88018, Ukraine

  • Valencia

    Valencia, 46026, Spain

  • Warszawa

    Warsaw, 02-952, Poland

  • Westmead, New South Wales

    Westmead, New South Wales, 2145, Australia

  • Wojnicz, Lskie

    Wojnicz, Wojnicz Lskie, 40-650, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.