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An Open-label Extension Trial of CVL-865 as Adjunctive Therapy in the Treatment of Focal Onset Seizures | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

A 57-Week, Multicenter, Active-treatment, Open-label Extension Trial of CVL-865 as Adjunctive Therapy in Adults With Drug-Resistant Focal Onset Seizures

NCT04686786•AbbVie

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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

Locations (56)

Little Rock, Arkansas

Little Rock, Arkansas, United States

New Haven, Connecticut

New Haven, Connecticut, United States

Gulf Breeze, Florida

Gulf Breeze, Florida, United States

Jacksonville, Florida

Jacksonville, Florida, United States

Miami Lakes, Florida

Miami Lakes, Florida, United States

Orlando, Florida

Orlando, Florida, United States

Port Charlotte, Florida

Port Charlotte, Florida, United States

Tampa, Florida

Tampa, Florida, United States

Honolulu, Hawaii

Honolulu, Hawaii, United States

Lexington, Kentucky

Lexington, Kentucky, United States

Key Dates

Start Date

December 8, 2020

Primary Completion Date

December 5, 2024

Completion Date

December 5, 2024

Last Updated

December 11, 2025

Enrollment

105

ACTUAL participants

Conditions

Seizures

Interventions

CVL-865

DRUG

A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

NCT05077904

Stereotypical Prolonged Seizures

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RECRUITINGPHASE3

A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures

NCT05667142

Primary Generalized Tonic-Clonic Seizures

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RECRUITINGPHASE3

LEvetiracetam to Prevent Seizures in Symptomatic Alzheimer's Disease in Adults With Down Syndrome

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures

LEvetiracetam to Prevent Seizures in Symptomatic Alzheimer's Disease in Adults With Down Syndrome

Longitudinal Study of Neurogenetic Disorders

SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures

Pharmacological Modulation of Brain Oscillations in Memory Processing