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

Focal Epilepsy Clinical Trial

— RISE 3  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06309966
• Other study ID #: BHV7000-303
• Secondary ID: 2023-808811-21-0
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 2024
• Est. completion date: September 2025

Study information

• Verified date: April 2024
• Source: Biohaven Pharmaceuticals, Inc.
• Contact: Chief Medical Officer
• Phone: 203-404-0410
• Email: clinicaltrials[@]biohavenpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 390
• Est. completion date: September 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 (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

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• Focal Epilepsy

Intervention

Drug:
• BHV-7000
BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily
• BHV-7000
BHV-7000 75 mg. Participants will take blinded investigational product (IP) once daily
• Placebo
Matching placebo taken once daily

Locations

Country	Name	City	State
United States	UNC-Chapel Hill	Chapel Hill	North Carolina
United States	MUSC	Charleston	South Carolina
United States	WR-ClinSearch	Chattanooga	Tennessee
United States	Cincinatti Children's Hospital	Cincinnati	Ohio
United States	ANESC Research	El Paso	Texas
United States	UTHealth Houston	Houston	Texas
United States	Dm Healthworks	Kissimmee	Florida
United States	Y&L Advance Health Care, Inc d/b/a Elite Clinical Research	Miami	Florida
United States	DelRicht Research	New Orleans	Louisiana
United States	University Medical Center New Orleans	New Orleans	Louisiana
United States	Comprehensive Neurology Clinic	Orlando	Florida
United States	Research Institute of Orlando	Orlando	Florida
United States	Knight Neurology	Rockledge	Florida
United States	PENS	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Biohaven Therapeutics Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in 28-day average seizure frequency during Weeks 8 to 16 of Treatment	To compare the efficacy of each of 2 doses of BHV-7000 to placebo as an adjunctive therapy for refractory focal onset epilepsy as measured by the change from baseline 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.	Baseline, Week 8 to Week 16