Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
completion around

Description

Summary

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

Keywords

Focal Epilepsy, Epilepsy, Seizure, Refractory Epilepsy, Partial Epilepsy, Partial Epilepsies, BHV-7000, BHV-7000 25 mg, BHV-7000 50 mg

Eligibility

You can join if…

Open to people ages 18-75

  1. Male and Female participants 18 to 75 years of age at time of consent.
  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.
    1. Focal seizures i. Focal aware seizures with clinically observable signs and/or symptoms ii. Focal impaired awareness seizures iii. Focal to bilateral tonic-clonic seizures
  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. Ability to keep accurate seizure diaries
  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.)

You CAN'T join if...

  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 seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit and during observation phase.
  3. Resection neurosurgery for seizures <4 months prior to the screening visit.
  4. Radiosurgery performed <2 years prior to the screening visit.
  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. 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

Locations

  • University of California San Diego not yet accepting patients
    La Jolla California 92041 United States
  • University of California, Los Angeles not yet accepting patients
    Los Angeles California 90095 United States
  • Profound Research LLC accepting new patients
    Pasadena California 91105 United States
  • Center for Neurosciences accepting new patients
    Tucson Arizona 85718 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Biohaven Therapeutics Ltd.
ID
NCT06132893
Phase
Phase 2/3 Epilepsy Research Study
Study Type
Interventional
Participants
Expecting 390 study participants
Last Updated