Generalized Epilepsy
Conditions
Keywords
Idiopathic Generalized Epilepsy, Generalized, Epilepsy, tonic-clonic, generalized tonic-clonic, tonic, clonic, seizure, refractory epilepsy, generalized tonic-clonic alone, juvenile myoclonic epilepsy, juvenile absence epilepsy
Brief 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.
Interventions
DRUGBHV-7000
BHV-7000 75mg. Participants will take blinded investigational product (IP) once daily
DRUGPlacebo
Matching placebo taken once daily
Sponsors
Biohaven Therapeutics Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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., each ASM is considered 1 treatment. Other epilepsy therapies including devices and diet therapy are allowed; together these other therapies count as 1 treatment). * 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 GTC seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit, or having repetitive/cluster GTC seizures 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to the Second Day with a Generalized Tonic Clonic (GTC) Seizure During the 24- week Double-blind Treatment Period | Baseline to Week 24 of 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with freedom of GTC seizures during DBT Phase | Baseline to Week 24 of Double-Blind Treatment Period | 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. |
| Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs | Baseline to Week 24 of Double-Blind Treatment Period | 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 |
| Number of Participants With Clinically Significant Laboratory Abnormalities | Baseline to Week 24 of Double-Blind Treatment Period | 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. |
Countries
Australia, Austria, Belgium, Croatia, Finland, France, Germany, Italy, Netherlands, Poland, Portugal, Spain, United Kingdom, United States
Outcome results
None listed