NCT06132893 A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
| NCT ID | NCT06132893 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Biohaven Therapeutics Ltd. |
| Condition | Focal Epilepsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 390 participants |
| Start Date | 2024-03-14 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 390 participants in total. It began in 2024-03-14 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
Eligibility 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06132893 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Focal Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06132893 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06132893 currently recruiting?
Yes, NCT06132893 is actively recruiting participants. Contact the research team at clinicaltrials@biohavenpharma.com for enrollment information.
Where is the NCT06132893 trial being conducted?
This trial is being conducted at Phoenix, United States, Tucson, United States, Little Rock, United States, Rogers, United States and 11 additional locations.
Who is sponsoring the NCT06132893 clinical trial?
NCT06132893 is sponsored by Biohaven Therapeutics Ltd.. The trial plans to enroll 390 participants.
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