RECRUITING

A 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, Randomized, 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:2024-03-14
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06132893

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)

Barrow Neurological Institute
Phoenix, Arizona, 85013
United States
Center for Neurosciences
Tucson, Arizona, 85718
United States
Clinical Trials, Inc.
Little Rock, Arkansas, 72205
United States
WRN
Rogers, Arkansas, 72758
United States
University of California San Diego
La Jolla, California, 92041
United States
University of California, Los Angeles
Los Angeles, California, 90095
United States
Stanford Health Care
Palo Alto, California, 94304
United States
Profound Research LLC
Pasadena, California, 91105
United States
University of Colorado Anschultz Medical Campus
Aurora, Colorado, 80045
United States
EZR Research LLC
Boca Raton, Florida, 33486
United States
Nova Clinical Research, LLC
Bradenton, Florida, 34209
United States
University of Florida (Jacksonville)
Jacksonville, Florida, 32209
United States
University of Miami
Miami, Florida, 33136
United States
Floridian Research Institute
Miami, Florida, 33179
United States
AdventHealth Orlando
Orlando, Florida, 32804
United States
Medsol Clinical Research Center
Port Charlotte, Florida, 33952
United States
Santos Research Center
Tampa, Florida, 33615
United States
Encore Medical Research of Weston LLC.
Weston, Florida, 33331
United States
Pediatrix Medical Group of Florida
Winter Park, Florida, 32789
United States
Augusta University
Augusta, Georgia, 30912
United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817
United States
Consultants in Epilepsy & Neurology, PLLC
Boise, Idaho, 83702
United States
Northwestern University
Chicago, Illinois, 60611
United States
Revive Research Institute, Inc.
Elgin, Illinois, 60123
United States
Accellacare
Ames, Iowa, 50010
United States
Bluegrass Epilepsy Research
Lexington, Kentucky, 40504
United States
MAESC
Bethesda, Maryland, 20817
United States
Javara
Silver Spring, Maryland, 20901
United States
Revive Research Institute, Inc.
Rochester Hills, Michigan, 48307
United States
Minnesota Epilepsy Group, P.A.
Roseville, Minnesota, 55113
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
NEREG
Hackensack, New Jersey, 07601
United States
Inst of Neurology
Livingston, New Jersey, 07039
United States
Dent Neurosciences Research Center
Amherst, New York, 14226
United States
BCHP
Hawthorne, New York, 10532
United States
Northwell Health
New York, New York, 10021
United States
Icahn School of Medicine at Mt. Sinai
New York, New York, 10029
United States
Stony Brook Medicine
Stony Brook, New York, 11794
United States
Five Towns Neuroscience Research
Woodmere, New York, 11598
United States
OnSite Clinical Solutions
Charlotte, North Carolina, 28211
United States
Accellacare
Mooresville, North Carolina, 28117
United States
Wake Forest Baptist
Winston-Salem, North Carolina, 27157
United States
NeuroScience Research Center
Canton, Ohio, 44718
United States
University of Cincinnati
Cincinnati, Ohio, 45267
United States
OSU
Columbus, Ohio, 43214
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Clinical Research Solutions LLC
Cypress, Texas, 77433
United States
Neurology Consultants of Dallas, PA
Dallas, Texas, 75243
United States
Tarrant Neurology Consultants
Fort Worth, Texas, 76104
United States
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
United States
UT Health San Antonio
San Antonio, Texas, 78229
United States
Road Runner Research, Ltd
San Antonio, Texas, 78249
United States
University of Utah
Salt Lake City, Utah, 84132
United States
UVM MC
Burlington, Vermont, 05401
United States
University of Virginia
Charlottesville, Virginia, 22903
United States
Henrico Doctors Neurology Associates, LLC
Richmond, Virginia, 23235
United States
Carilion Clinic
Roanoke, Virginia, 24011
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 Date2024-03-14
Study Completion Date2025-09

Study Record Updates

Study Start Date2024-03-14
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