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Hawaii Pacific Neuroscience | Clinical Research Center

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A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy (RISE 2)

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Biohaven

Status and phase

Enrolling
Phase 3
Phase 2

Conditions

Focal Epilepsy

Treatments

Drug: BHV-7000
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06132893
2023-508539-30 (Registry Identifier)
BHV7000-302

Details and patient eligibility

About

The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.

Enrollment

390 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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 (e.g., 3 ASMs + 1 diet regimen; 2 ASMs + 1 diet regimen + 1 device, etc.)

Exclusion criteria

  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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

390 participants in 3 patient groups, including a placebo group

BHV-7000 25 mg
Experimental group
Treatment:
Drug: BHV-7000
Drug: BHV-7000
BHV-7000 50 mg
Experimental group
Treatment:
Drug: BHV-7000
Drug: BHV-7000
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

59

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Central trial contact

Chief Medical Officer

Data sourced from clinicaltrials.gov

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