Enrolling by invitation NCT06443463

Long-term Safety and Tolerability of BHV-7000

Phase II 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.
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, Australia, Austria, Belgium +22
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, Global, Multicenter, Long-term Safety Study Designed to Assess the Safety and Tolerability of BHV-7000 in Subjects With Refractory Focal Onset Epilepsy

Overview

A study to determine if BHV- 7000 is safe and tolerable in adults with refractory focal onset epilepsy

Interventions

Drug BHV-7000
BHV-7000 50 mg. Participants will take open-label investigational product (IP) once daily
Drug BHV-7000
BHV-7000 75 mg. Participants will take open-label investigational product (IP) once daily

Primary outcome measures

Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs [Time frame: Up to 104 weeks]
Number of Subjects with Clinically Significant Laboratory Abnormalities [Time frame: Up to 104 weeks]

Eligibility criteria

Inclusion criteria

Subjects who completed the double-blind phase (DBP) of prior parent study, BHV7000-302 or BHV7000-303.
(FOCBP) Females of Child Bearing Potential must have a negative urine pregnancy test at the Baseline/Day 0 visit

Exclusion criteria

Any condition, such as an ongoing AE with/without sequelae, or is poorly tolerating IP in the double-blind phase of the parent study, 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.
Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures

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

Healthy volunteers: No

Study design

Allocation: Non-randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment