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

February 23, 2024 updated by: Cerevel Therapeutics, LLC

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Camperdown, New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Randwick, New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Westmead, New South Wales
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Herston, Queensland
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • Fitzroy, Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Heidelberg, Victoria
      • Melbourne, Victoria, Australia, 3004
        • Melbourne, Victoria
      • Parkville, Victoria, Australia, 3050
        • Parkville, Victoria
  • Poland
    • Kujawsko-Pomorskie
      • Bydgoszcz, Kujawsko-Pomorskie, Poland, 85-163
        • Bydgoszcz, Kujawsko-Pomorskie
    • Pomorskie
      • Gdańsk, Pomorskie, Poland, 80-803
        • Gdańsk, Pomorskie
    • Wojnicz Lskie
      • Wojnicz, Wojnicz Lskie, Poland, 40-650
        • Wojnicz, Lskie
  • Spain
      • Madrid, Spain, 28034
        • Madrid
      • Madrid, Spain, 28040
        • Madrid
      • Sevilla, Spain, 41013
        • Sevilla
      • Valencia, Spain, 46026
        • Valencia
    • Andalusia
      • Málaga, Andalusia, Spain, 29010
        • Malaga,
    • Catalonia
      • Barcelona, Catalonia, Spain, 08003
        • Barcelona, Catalunya
      • Barcelona, Catalonia, Spain, 08035
        • Barcelona, Catalonia
      • Terrassa, Catalonia, Spain, 08222
        • Terrassa, Catalonia
  • Ukraine
      • Lviv, Ukraine, 79035
        • Lviv
    • Uzhgorod
      • Úzhgorod, Uzhgorod, Ukraine, 88018
        • Uzhgorod
  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • New Haven, Connecticut
    • Florida
      • Gulf Breeze, Florida, United States, 32561-4458
        • Gulf Breeze, Florida
      • Jacksonville, Florida, United States, 32224
        • Jacksonville, Florida
      • Orlando, Florida, United States, 32806
        • Orlando, Florida
      • Port Charlotte, Florida, United States, 33952
        • Port Charlotte, Florida
      • Tampa, Florida, United States, 33606
        • Tampa, Florida
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Honolulu, Hawaii
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Lexington, Kentucky
    • Maine
      • Scarborough, Maine, United States, 04074
        • Scarborough, Maine
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Baltimore, Maryland
      • Bethesda, Maryland, United States, 20817
        • Bethesda, Maryland
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Boston, Massachusetts
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Saint Louis, Missouri
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack, New Jersey
    • New York
      • New York, New York, United States, 10021
        • New York
      • Rochester, New York, United States, 14642
        • Rochester, New York
    • Ohio
      • Toledo, Ohio, United States, 43614
        • Toledo, Ohio
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Oklahoma City, Oklahoma
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Philadelphia, Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Philadelphia, Pennsylvania
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Charleston, South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Nashville, Tennessee
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Salt Lake City, Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CVL-865 25 mg
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.
Drug: CVL-865
Participants will receive 25 mg CVL-865 tablets orally BID during the treatment period. The dose may be decreased to 17.5 mg BID for tolerability.
Other Names:
  • PF-06372865

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment Emergent Adverse Event (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Time Frame: From first dose of study drug up to Week 61 (follow up period)
TEAEs will include abuse-related adverse events (AEs) and AEs related to medication handling irregularities (MHIs). The number of Participants With TEAEs and TESAEs will be assessed.
From first dose of study drug up to Week 61 (follow up period)
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECGs)
Time Frame: Baseline up to Week 57 or early termination (ET)
12-lead ECGs recordings will be obtained after the participant has been supine and at rest for at least 5 minutes.
Baseline up to Week 57 or early termination (ET)
Number of Participants with Clinically Significant Changes in Vital Sign Measurements
Time Frame: Baseline up to Week 57 or early termination (ET)
Vital signs will be measured with the participant in a sitting/semi-recumbent position after 5 minutes rest and will include temperature, systolic and diastolic blood pressure, and heart rate.
Baseline up to Week 57 or early termination (ET)
Number of Participants with Clinically Significant Changes in Physical and Neurological Examination Results
Time Frame: Baseline up to Week 57 or early termination (ET)
Number of participants with clinically significant changes in physical and neurological examination results will be assessed.
Baseline up to Week 57 or early termination (ET)
Number of Participants With Positive Response to Columbia Suicide-Severity Rating Scale (C-SSRS)
Time Frame: Baseline up to Week 61 (follow up period)
The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).
Baseline up to Week 61 (follow up period)
Number of Participants with Positive Response to Modified Clinical Institute Withdrawal Assessment - Benzodiazepines (mCIWA-B)
Time Frame: Week 54 up to Week 61
The modified Clinical Institute Withdrawal Assessment - Benzodiazepines (mCIWA-B) is a sensitive instrument to measure withdrawal under conditions where there is a taper of medication (rather than abrupt discontinuation). It consists of 17-items that monitor the type and severity of BZD withdrawal symptoms such as irritability, fatigue, appetite, and sleeplessness. The total score ranges from 1 to 68 with higher scores indicating more severe withdrawal.
Week 54 up to Week 61

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cerevel Therapeutics, LLC

Investigators

  • Study Director: Eliza Hueda, Cerevel Therapeutics, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2020

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

December 23, 2020

First Submitted That Met QC Criteria

December 23, 2020

First Posted (Actual)

December 29, 2020

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVL-865-SZ-002
  • 2019-004057-83 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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