A Study to Determine if BHV-7000 is Effective and Safe in Adults With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures (SHINE)

June 17, 2024 updated by: Biohaven Therapeutics Ltd.

A Phase 2/3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BHV-7000 as Adjunctive Therapy in Subjects With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures, With Open-label Extension

The purpose of this study is to determine whether BHV-7000 is effective in the treatment of idiopathic generalized epilepsy with generalized tonic-clonic seizures and includes an additional open-label extension (OLE) phase.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

242

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85015
      • Tucson, Arizona, United States, 85718
        • Recruiting
        • Center for Neurosciences
        • Contact:
    • California
    • Florida
      • Bradenton, Florida, United States, 34209
      • Jacksonville, Florida, United States, 32209
        • Not yet recruiting
        • University of Florida (Jacksonville)
        • Contact:
      • Orlando, Florida, United States, 32806
      • Rockledge, Florida, United States, 32955
      • Weston, Florida, United States, 33331
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
    • Illinois
      • Elgin, Illinois, United States, 60123
        • Not yet recruiting
        • Revive Research Institute, Inc.
        • Contact:
    • Kentucky
      • Lexington, Kentucky, United States, 40504
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
    • Michigan
      • Rochester Hills, Michigan, United States, 48307
        • Recruiting
        • Revive Research Institute, Inc.
        • Contact:
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • Recruiting
        • Inst of Neurology
        • Contact:
    • New York
      • Amherst, New York, United States, 14226
        • Not yet recruiting
        • Dent Neurosciences Research Center
        • Contact:
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
      • Nashville, Tennessee, United States, 37232
        • Not yet recruiting
        • Vanderbilt University Medical Center
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75243
        • Not yet recruiting
        • Neurology Consultants of Dallas, PA
        • Contact:
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • UTHealth Houston
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male and Female participants 18 to 75 years of age at time of consent.

  • Diagnosis of Idiopathic Generalized Epilepsy at least 6 months prior to the screening visit, defined by 2017 International League Against Epilepsy (ILAE) Classification and based on requirements of Epilepsy Adjudication criteria.

    1. Subject has probable GTC seizures in the setting of IGE, meaning GTC seizures and either classic 3-4 Hz generalized spike-wave (GSW) or 4-6 Hz polyspike-wave on EEG and no focal abnormality (asymmetric spike-wave fragment is allowed) AND/OR a clear history of absence seizures or myoclonic jerks
    2. Subjects with possible GTC seizures in the setting of IGE, meaning GTC and either Normal EEG OR Generalized epileptiform EEG abnormality with atypical spike-wave and no focal abnormality (asymmetric spike-wave fragment is allowed).
  • Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used ASM schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom.
  • Ability of subject or caregiver to keep accurate seizure diaries
  • Current treatment with at least 1 to 3 ASMs as part of no more than 4 epilepsy treatments in total (e.g., 3 ASMs + 1 diet regimen; 2 ASMs + 1 diet regimen + 1 device, etc.).
  • Accurate history of having at least 3 days with a GTC seizure evenly spread throughout the 16 weeks prior to the screening visit, such that a subject had at least 1 day with a GTC seizure during the first 8 weeks and at least 1 day with a GTC seizure during the second 8 weeks.

Exclusion Criteria:

  • History of status epilepticus (convulsive status epilepticus for > 5 minutes or focal status epilepticus with impaired conscious for > 10 minutes) within the last 6 months prior to screening visit that is not consistent with the subject's habitual seizure.
  • History of repetitive/cluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit, or having an unknown GTC seizure count during the screening phase.
  • Any condition that would interfere with and/or confound the interpretation of safety or efficacy data from the study, as judged by the Investigator

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Matching placebo taken once daily
Active Comparator: BHV-7000 75 mg
Drug: BHV-7000
BHV-7000 75mg. Participants will take blinded investigational product (IP) once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to the Second Day with a Generalized Tonic Clonic (GTC) Seizure During the 24- week Double-blind Treatment Period
Time Frame: Baseline to Week 24 of Double-Blind Treatment Period
To compare the efficacy of BHV-7000 to placebo as adjunctive therapy for subjects with idiopathic generalized epilepsy with generalized tonic-clonic (GTC) seizures as measured by the time to the second day with a GTC seizure during the double-blind phase
Baseline to Week 24 of Double-Blind Treatment Period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with freedom of GTC seizures during DBT Phase
Time Frame: Baseline to Week 24 of Double-Blind Treatment Period
To compare the efficacy of BHV-7000 to placebo in terms of the proportion of subjects that are free of GTC seizures as measured by the proportion of subjects with GTC seizure freedom during the 24-week DBP, estimated using Kaplan- Meier methods.
Baseline to Week 24 of Double-Blind Treatment Period
Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs
Time Frame: Baseline to Week 24 of Double-Blind Treatment Period
To assess the safety and tolerability of BHV-7000 as measured by the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs
Baseline to Week 24 of Double-Blind Treatment Period
Number of Participants With Clinically Significant Laboratory Abnormalities
Time Frame: Baseline to Week 24 of Double-Blind Treatment Period
To assess the safety and tolerability of BHV-7000 as measured by the number of unique subjects with grade 3 and grade 4 laboratory abnormalities.
Baseline to Week 24 of Double-Blind Treatment Period

Collaborators and Investigators

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

Sponsor

Biohaven Therapeutics Ltd.

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 (Estimated)

June 1, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

May 17, 2024

First Submitted That Met QC Criteria

May 17, 2024

First Posted (Actual)

May 22, 2024

Study Record Updates

Last Update Posted (Estimated)

June 18, 2024

Last Update Submitted That Met QC Criteria

June 17, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHV7000-304
  • 2023-508812-45-00 (Other Identifier: EU CTR)

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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