Efficacy, Safety and Tolerability of BHV-7000 in Subjects with Idiopathic Generalized Epilepsy with Generalized Tonic-clonic Seizures – SHINE

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Biohaven Therapeutics Ltd.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

11 Nov 2024 → 13 Mar 2026

Decision date (initial)

2024-10-14

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Biohaven Therapeutics, Ltd. c/o Biohaven Pharmaceuticals, Inc. (BPI)

External identifiers

EU CT number

2023-508812-45-00

ClinicalTrials.gov

NCT06425159

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Others, Safety, Pharmacokinetic

To compare the efficacy of BHV-7000 to placebo as adjunctive therapy for subjects with IGE with GTC as measured by the time to the second day with a GTC seizure during the double-blind phase.

Secondary objectives 1

1. - To compare the efficacy of BHV-7000 to that of placebo in terms of the proportion of subjects that are free of GTC seizures - To assess the safety and tolerability of BHV-7000

Conditions and MedDRA coding

Idiopathic Generalized Epilepsy with Generalized Tonic-clonic Seizures

Study design 3 periods

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, Food And Drug Administration

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Inclusion Criteria: - Male and Female participants 18 to 75 years of age at time of consent. - Diagnosis of Idiopathic Generalized Epilepsy (IGE) 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. - Subject has probable generalized tonic-clonic (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 electroencephalogram (EEG) and no focal abnormality (asymmetric spikewave fragment is allowed) AND/OR a clear history of absence seizures or myoclonic jerks - 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 anti-seizure medication (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 1

1. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Time to the second day with a GTC seizure during the double-blind phase.

Secondary endpoints 1

1. - Proportion of subjects with GTC seizure freedom during the 24-week DBP, estimated using Kaplan-Meier methods. - Safety is assessed by the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, moderate and severe AEs, and grade 3 and grade 4 laboratory abnormalities.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Biohaven Therapeutics Ltd.

Sponsor organisation

Biohaven Therapeutics Ltd.

Address

215 Church Street

City

New Haven

Postcode

06510-1803

Country

United States

Scientific contact point

Organisation

Biohaven Therapeutics Ltd.

Contact name

Research and Development Medical Director

Public contact point

Organisation

Biohaven Therapeutics Ltd.

Contact name

Chief Compliance Officer

Third parties 9

Locations

11 EU/EEA countries · 60 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 113 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications