A Study to Determine if BHV-7000 is Effective and Safe in Adults With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures

Generalized Epilepsy Clinical Trial

— SHINE  

Official title:

A Phase 2/3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BHV-7000 as Adjunctive Therapy in Subjects With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures, With Open-label Extension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06425159
• Other study ID #: BHV7000-304
• Secondary ID: 2023-508812-45-0
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: June 2024
• Est. completion date: July 2027

Study information

• Verified date: June 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 idiopathic generalized epilepsy with generalized tonic-clonic seizures and includes an additional open-label extension (OLE) phase.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 242
• Est. completion date: July 2027
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male and Female participants 18 to 75 years of age at time of consent.
• Diagnosis of Idiopathic Generalized Epilepsy at least 6 months prior to the screening visit, defined by 2017 International League Against Epilepsy (ILAE) Classification and based on requirements of Epilepsy Adjudication criteria.

1. Subject has probable GTC seizures in the setting of IGE, meaning GTC seizures and either classic 3-4 Hz generalized spike-wave (GSW) or 4-6 Hz polyspike-wave on EEG and no focal abnormality (asymmetric spike-wave fragment is allowed) AND/OR a clear history of absence seizures or myoclonic jerks

2. Subjects with possible GTC seizures in the setting of IGE, meaning GTC and either Normal EEG OR Generalized epileptiform EEG abnormality with atypical spike-wave and no focal abnormality (asymmetric spike-wave fragment is allowed).

• Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used ASM schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom.
• Ability of subject or caregiver to keep accurate seizure diaries
• Current treatment with at least 1 to 3 ASMs as part of no more than 4 epilepsy treatments in total (e.g., 3 ASMs + 1 diet regimen; 2 ASMs + 1 diet regimen + 1 device, etc.).
• Accurate history of having at least 3 days with a GTC seizure evenly spread throughout the 16 weeks prior to the screening visit, such that a subject had at least 1 day with a GTC seizure during the first 8 weeks and at least 1 day with a GTC seizure during the second 8 weeks.

Exclusion Criteria:

• 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.
• History of repetitive/cluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit, or having an unknown GTC seizure count during the screening phase.
• Any condition that would interfere with and/or confound the interpretation of safety or efficacy data from the study, as judged by the Investigator

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Generalized
• Generalized Epilepsy
• Seizures

Intervention

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

Locations

Country	Name	City	State
United States	Dent Neurosciences Research Center	Amherst	New York
United States	OLOLRMC	Baton Rouge	Louisiana
United States	Nova Clinical Research, LLC	Bradenton	Florida
United States	OnSite Clinical Solutions	Charlotte	North Carolina
United States	WR-ClinSearch	Chattanooga	Tennessee
United States	Neurology Consultants of Dallas, PA	Dallas	Texas
United States	Revive Research Institute, Inc.	Elgin	Illinois
United States	Hawaii Pacific Neuroscience	Honolulu	Hawaii
United States	UTHealth Houston	Houston	Texas
United States	University of Florida (Jacksonville)	Jacksonville	Florida
United States	Bluegrass Epilepsy Research	Lexington	Kentucky
United States	Inst of Neurology	Livingston	New Jersey
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Research Institute of Orlando	Orlando	Florida
United States	Profound Research LLC	Pasadena	California
United States	ARENSIA Exploratory Medicine	Phoenix	Arizona
United States	Revive Research Institute, Inc.	Rochester Hills	Michigan
United States	Knight Neurology	Rockledge	Florida
United States	Center for Neurosciences	Tucson	Arizona
United States	Encore Medical Research of Weston LLC.	Weston	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	Time to the Second Day with a Generalized Tonic Clonic (GTC) Seizure During the 24- week Double-blind Treatment Period	To compare the efficacy of BHV-7000 to placebo as adjunctive therapy for subjects with idiopathic generalized epilepsy with generalized tonic-clonic (GTC) seizures as measured by the time to the second day with a GTC seizure during the double-blind phase	Baseline to Week 24 of Double-Blind Treatment Period
Secondary	Percentage of Participants with freedom of GTC seizures during DBT Phase	To compare the efficacy of BHV-7000 to placebo in terms of the proportion of subjects that are free of GTC seizures as measured by the proportion of subjects with GTC seizure freedom during the 24-week DBP, estimated using Kaplan- Meier methods.	Baseline to Week 24 of Double-Blind Treatment Period
Secondary	Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs	To assess the safety and tolerability of BHV-7000 as measured by the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs	Baseline to Week 24 of Double-Blind Treatment Period
Secondary	Number of Participants With Clinically Significant Laboratory Abnormalities	To assess the safety and tolerability of BHV-7000 as measured by the number of unique subjects with grade 3 and grade 4 laboratory abnormalities.	Baseline to Week 24 of Double-Blind Treatment Period