Generalized Epilepsy Clinical Trial
— SHINEOfficial 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
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Biohaven Therapeutics Ltd. |
United States,
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 |
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