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Evaluating BHV-7000 for treating refractory focal epilepsy in adults

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

Phase2; Phase3 Interventional Biohaven Pharmaceuticals, Inc. · NCT06309966

This study is testing a new drug called BHV-7000 to see if it can help adults with hard-to-treat focal epilepsy who haven't found relief from other treatments.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment390 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorBiohaven Pharmaceuticals, Inc. Industry-sponsored
Locations174 sites (Birmingham, Alabama and 173 other locations)
Trial IDNCT06309966 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness and safety of BHV-7000 in adults suffering from refractory focal onset epilepsy. Participants will receive either the investigational drug or a placebo, and their responses will be monitored over time. The study includes individuals aged 18 to 75 who have a history of focal seizures and have not achieved seizure freedom despite previous treatments. The goal is to determine if BHV-7000 can provide a new therapeutic option for this challenging condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a diagnosis of refractory focal onset epilepsy and a history of inadequate response to multiple anti-seizure medications.

Not a fit: Patients with a history of status epilepticus or those who do not meet the criteria for refractory epilepsy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new hope for patients with refractory focal epilepsy who have limited options.

How similar studies have performed: Other studies have explored treatments for refractory epilepsy, but the specific approach with BHV-7000 is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

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.

   a. Focal seizures i. Focal aware seizures with clinically observable signs and/or symptoms ii. Focal impaired awareness seizures with clinically observable signs and/or symptoms 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

Key Exclusion Criteria:

1. History of status epilepticus (convulsive status epilepticus for \> 5 minutes or focal status epilepticus with impaired consciousness 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

Where this trial is running

Birmingham, Alabama and 173 other locations

+124 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Focal EpilepsyEpilepsySeizureRefractory EpilepsyPartial Epilepsy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.