RECRUITING

Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy

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Conditions

Focal EpilepsyEpilepsySeizureRefractory EpilepsyPartial 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 refractory focal epilepsy.

Official Title

A Phase 2/3 Multicenter, Randomization, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of BHV-7000 in Subjects With Refractory Focal Onset Epilepsy

Quick Facts

Study Start:2024-05-13
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06309966

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. 1. Male and Female participants 18 to 75 years of age at time of consent.
  2. 2. Diagnosis of Focal Onset Epilepsy at least 1 year prior to screening visit defined by 2017 International League Against Epilepsy (ILAE) Classification and based on requirements of Epilepsy Adjudication criteria.
  3. 3. Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used anti-seizure medication (ASM) schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom.
  4. 4. Ability to keep accurate seizure diaries
  5. 5. Current treatment with at least 1 and up to 3 ASMs and 4 epilepsy treatments in total (e.g., 3 ASMs + 1 diet regimen; 2 ASMs + 1 diet regimen + 1 device, etc.)
  1. 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. 2. History of repetitive/cluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit and during observation phase.
  3. 3. Resection neurosurgery for seizures \<4 months prior to the screening visit.
  4. 4. Radiosurgery performed \<2 years prior to the screening visit.
  5. 5. Subjects with only focal aware nonmotor seizures which involve subjective sensory or psychic phenomena only, without impairment of consciousness or awareness (formally called simple partial seizures), with or without ictal EEG correlation with clinical symptoms.
  6. 6. Any condition that would interfere with the subject's ability to comply with study instructions, place the subject at unacceptable risk, and/or confound the interpretation of safety or efficacy data from the study, as judged by the Investigator

Contacts and Locations

Study Contact

Chief Medical Officer
CONTACT
203-404-0410
clinicaltrials@biohavenpharma.com

Study Locations (Sites)

Xenoscience, Inc.
Phoenix, Arizona, 85004
United States
ARENSIA Exploratory Medicine
Phoenix, Arizona, 85015
United States
Amicis Research Center
Lancaster, California, 93534
United States
Memorialcare Miller Children's & Women's Hospital Long Beach
Long Beach, California, 90806
United States
Profound Research LLC
Poway, California, 92065
United States
Kaiser Permanente
Aurora, Colorado, 80011
United States
UConn Health
Farmington, Connecticut, 06030
United States
Children's National Medical Center
Washington, District of Columbia, 20010
United States
Dm Healthworks
Kissimmee, Florida, 34741
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
PENS
Tampa, Florida, 33609
United States
DelRicht Research
Baton Rouge, Louisiana, 70810
United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112
United States
DelRicht Research
New Orleans, Louisiana, 70119
United States
LSU Health Shreveport
Shreveport, Louisiana, 71103
United States
Johns Hopkins University
Baltimore, Maryland, 21287
United States
Somnos Clinical Research
Lincoln, Nebraska, 68510
United States
Northwell Health
Great Neck, New York, 11021
United States
NYU Langone Health
New York, New York, 10016
United States
UNC-Chapel Hill
Chapel Hill, North Carolina, 27514
United States
Cincinatti Children's Hospital
Cincinnati, Ohio, 45229
United States
AHN
Pittsburgh, Pennsylvania, 15212
United States
MUSC
Charleston, South Carolina, 29425
United States
WR-ClinSearch
Chattanooga, Tennessee, 37421
United States
Le Bonheur Children's Hospital
Memphis, Tennessee, 38103
United States
ANESC Research
El Paso, Texas, 79912
United States
UTHealth Houston
Houston, Texas, 77030
United States
Intermountain Health
Murray, Utah, 84107
United States
Medstar Health Research Institute
McLean, Virginia, 22101
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 Date2024-05-13
Study Completion Date2025-09

Study Record Updates

Study Start Date2024-05-13
Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

  • Focal Epilepsy
  • Epilepsy
  • Seizure
  • Refractory Epilepsy
  • Partial Epilepsy

Additional Relevant MeSH Terms

  • Focal Epilepsy