Recruiting NCT06132893

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

Phase II / Phase III Interventional Focal Epilepsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: BHV-7000, BHV-7000, Placebo, BHV-7000.
Who it may be relevant to: Registry conditions: Focal Epilepsy. Basic parameters: 18 years — 75 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Austria, Belgium, Chile +9
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Phase 2/3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of BHV-7000 in Subjects With Refractory Focal Onset Epilepsy

Overview

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

Detailed description

This study has two parts, Part A and Part B. Part A is randomized 1:1:1 25 mg of BHV-7000, 50 mg of BHV-7000 or matching placebo. Part B is randomized 1:1 75mg BHV-7000 or matching placebo. Part B will start after Part A.

Interventions

Drug BHV-7000
BHV-7000 25 mg. Participants will take blinded investigational product (IP) once daily
Drug BHV-7000
BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily
Drug Placebo
Matching placebo taken once daily
Drug BHV-7000
BHV-7000 75 mg. Participants willtake blinded investigational product(IP) once daily
Drug Placebo
Matching placebo taken once daily

Primary outcome measures

Part B: Change from Baseline in 28-day average seizure frequency [Time frame: Baseline, Week 8 to Week 20 of Part B]
Part A: Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs [Time frame: Week 8 to Week 20 of Part A]
Part A: Number of Participants With Clinically Significant Laboratory Abnormalities [Time frame: Week 8 to Week 20 of Part A]

Secondary outcome measures (8)

Part B: Percentage of Participants with at at least 50% reduction in seizure frequency per month [Time frame: Baseline, Week 8 to Week 20 of Part B]
Part B: Change from Baseline in 28-day average seizure frequency during first month of treatment [Time frame: Baseline, Week 8 to Week 12 of Part B]
Part B: Percentage of Participants with at at least 75% reduction in seizure frequency per month [Time frame: Baseline, Week 8 to Week 20 of Part B]
Part B: Percentage of Participants with seizure freedom during DB Phase [Time frame: Week 8 to Week 20 of Part B]
Part B: Change from baseline in 7-day adjusted seizure frequency during first week of treatment [Time frame: Baseline, Week 8 to Week 9 of Part B]
Part B: Change from baseline in Patient Global Impression of Change (PGI-C) [Time frame: Baseline, Week 20 of Part B]
Part B: Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs [Time frame: Week 8 to Week 20 of Part B]
Part B: Number of Participants With Clinically Significant Laboratory Abnormalities [Time frame: Week 8 to Week 20 of Part B]

Eligibility criteria

Inclusion criteria

Male and Female participants 18 to 75 years of age at time of consent.
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 iii. Focal to bilateral tonic-clonic seizures

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 to keep accurate seizure diaries
Current treatment with at least 1 and up to 3 ASMs and 4 epilepsy treatments in total

Exclusion criteria

History of status epilepticus (convulsive status epilepticus for > 5 minutes or focal status epilepticus with impaired consciousness 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 and during observation phase.
Resection neurosurgery for seizures <4 months prior to the screening visit.
Radiosurgery performed <2 years prior to the screening visit.
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.
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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Sequential
Masking: Quadruple blind
Primary purpose: Treatment