Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06309966

Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Focal Epilepsy Brain Diseases Central Nervous System Diseases Drug Resistant Epilepsy Epilepsies, Partial Epilepsy Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Male and Female participants 18 to 75 years of age at time of consent.
  • 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

  • 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.
  • Ability to keep accurate seizure diaries
  • Current treatment with at least 1 and up to 3 ASMs and 4 epilepsy treatments in total

Key Exclusion Criteria:

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

Treatment and study plan

BHV-7000

Drug

BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily

Placebo

Drug

Matching placebo taken once daily

Primary outcomes

  1. Change from Baseline in 28-day average seizure frequency

    Time frame: Baseline, Week 8 to Week 16

    To compare the efficacy of 75mg of BHV-7000 to placebo as an adjunctive therapy for refractory focal onset epilepsy as measured by the change from OP (observational phase) in 28-day average seizure frequency. The primary objective will be measured by comparing the observation phase (8 weeks) to the 8-week double-blind treatment phase.

Secondary outcomes

  1. Percentage of Participants with at at least 50% reduction in seizure frequency per month

    Time frame: Baseline, Week 8 to Week 16

    To compare the efficacy 75mg of BHV-7000 to placebo as adjunctive therapy for refractory focal onset epilepsy as measured by the proportion of subjects that have at least a 50% reduction in seizures per month (28 days). This objective will be measured by comparing the proportion of subjects with at least a 50% reduction in 28-day average seizure frequency over the course of the 8 week double-blind phase to the observation phase.

  2. Change from Baseline in 28-day average seizure frequency

    Time frame: Baseline, Week 8 to Week 16

    To compare the efficacy of each of 50mg of BHV-7000 to placebo as an adjunctive therapy for refractory focal onset epilepsy as measured by the change from OP (observational phase) in 28-day average seizure frequency.

  3. Percentage of Participants with at at least 50% reduction in seizure frequency per month

    Time frame: Baseline, Week 8 to Week 16

    To compare the efficacy of 50mg of BHV-7000 to placebo as adjunctive therapy for refractory focal onset epilepsy as measured by the proportion of subjects that have at least a 50% reduction in seizures per month (28 days). This objective will be measured by comparing the proportion of subjects with at least a 50% reduction in 28-day average seizure frequency over the course of the 8 week double-blind phase to the observation phase.

  4. Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs

    Time frame: Week 8 to Week 16

    To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs.

  5. Number of Participants With Clinically Significant Laboratory Abnormalities

    Time frame: Week 8 to Week 16

    To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 or 4 laboratory abnormalities.

Sponsors and collaborators

Lead sponsor

Biohaven Therapeutics Ltd.

Industry

Registry information

Official study title

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

Acronym: RISE 3

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2024
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.