ACTIVE_NOT_RECRUITING

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

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Conditions

Generalized EpilepsyIdiopathic Generalized EpilepsyGeneralizedEpilepsytonic-clonicgeneralized tonic-clonictonicclonicseizurerefractory epilepsygeneralized tonic-clonic alonejuvenile myoclonic epilepsyjuvenile absence epilepsy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-06-20
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06425159

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male and Female participants 18 to 75 years of age at time of consent.
  2. * 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.
  3. 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
  4. 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).
  5. * 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.
  6. * Ability of subject or caregiver to keep accurate seizure diaries
  7. * Current treatment with at least 1 to 3 ASMs as part of no more than 4 epilepsy treatments in total (e.g., each ASM is considered 1 treatment. Other epilepsy therapies including devices and diet therapy are allowed; together these other therapies count as 1 treatment).
  8. * 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.
  1. * 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.
  2. * History of repetitive/cluster GTC seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit, or having repetitive/cluster GTC seizures count during the screening phase.
  3. * Any condition that would interfere with and/or confound the interpretation of safety or efficacy data from the study, as judged by the Investigator

Contacts and Locations

Study Locations (Sites)

Accel Research
Birmingham, Alabama, 35244
United States
Barrow Neurological Institute
Phoenix, Arizona, 85013
United States
ARENSIA Exploratory Medicine
Phoenix, Arizona, 85015
United States
Center for Neurosciences
Tucson, Arizona, 85718
United States
Profound Research LLC
Pasadena, California, 91105
United States
Medstar Health Research Institute
Washington D.C., District of Columbia, 20010
United States
Nova Clinical Research, LLC
Bradenton, Florida, 34209
United States
University of Florida (Jacksonville)
Jacksonville, Florida, 32209
United States
Y&L Advance Health Care,Inc d/b/a Elite Clinical Research
Miami, Florida, 33144
United States
Serenity Research Center
Miami, Florida, 33176
United States
Research Institute of Orlando
Orlando, Florida, 32806
United States
Comprehensive Neurology Clinic
Orlando, Florida, 32825
United States
Knight Neurology
Rockledge, Florida, 32955
United States
Santos Research Center
Tampa, Florida, 33615
United States
Encore Medical Research of Weston LLC.
Weston, Florida, 33331
United States
Augusta University
Augusta, Georgia, 30912
United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817
United States
Consultants in Epilepsy & Neurology, PLLC (CEN)
Boise, Idaho, 83702
United States
Northwestern Medical Group, Department of Neurology
Chicago, Illinois, 60611
United States
Revive Research Institute, Inc.
Elgin, Illinois, 60123
United States
Bluegrass Epilepsy Research
Lexington, Kentucky, 40504
United States
OLOLRMC
Baton Rouge, Louisiana, 70808
United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112
United States
Boston Clinical Trials
Boston, Massachusetts, 02131
United States
Somnos Clinical Research
Lincoln, Nebraska, 68510
United States
NEREG
Hackensack, New Jersey, 07601
United States
Institute of Neurology and Neurosurgery
Livingston, New Jersey, 07039
United States
Dent Neurosciences Research Center
Amherst, New York, 14226
United States
Boston Children's Health Physicians (BCHP)
Hawthorne, New York, 10532-1528
United States
Northwell Health Pediatric Neurology
New Hyde Park, New York, 11042
United States
NYU Langone Health
New York, New York, 10016
United States
Montefiore Medical Center
The Bronx, New York, 10467
United States
UPMC
Pittsburgh, Pennsylvania, 15213
United States
WR-ClinSearch
Chattanooga, Tennessee, 37421
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Neurology Consultants of Dallas, PA
Dallas, Texas, 75243
United States
ANESC Research
El Paso, Texas, 79912
United States
Road Runner Research, Ltd
San Antonio, Texas, 78249
United States
Intermountain Health
Murray, Utah, 84107
United States
Henrico Doctors' Neurology Associates, LLC
Richmond, Virginia, 23235
United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2024-06-20
Study Completion Date2027-07

Study Record Updates

Study Start Date2024-06-20
Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

  • Idiopathic Generalized Epilepsy
  • Generalized
  • Epilepsy
  • tonic-clonic
  • generalized tonic-clonic
  • tonic
  • clonic
  • seizure
  • refractory epilepsy
  • generalized tonic-clonic alone
  • juvenile myoclonic epilepsy
  • juvenile absence epilepsy

Additional Relevant MeSH Terms

  • Generalized Epilepsy