Long-term Safety and Tolerability of BHV-7000

Biohaven

Status and phase: Invitation-only; Phase 2

Conditions: Focal Epilepsy

Treatments: Drug: BHV-7000

Study type: Interventional

Funder types: Industry

Identifiers

NCT06443463

2023-508813-18-00 (EU Trial (CTIS) Number)

BHV7000-201

Details and patient eligibility

About

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

Enrollment: 660 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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660 participants in 2 patient groups

BHV-7000 50 mg

Experimental group

Treatment:

Drug: BHV-7000

Drug: BHV-7000

BHV-7000 75 mg

Experimental group

Treatment:

Drug: BHV-7000

Drug: BHV-7000