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Enrolling by Invitation

NCT Number: NCT06443463

Long-term Safety and Tolerability of BHV-7000

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

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Key information

Conditions

Focal Epilepsy Brain Diseases Central Nervous System Diseases Drug Resistant Epilepsy Epilepsies, Partial Epilepsy Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

STAT Research S.A., Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BHV-7000

Drug

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

Primary outcomes

  1. 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

    To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs.

  2. Number of Subjects with Clinically Significant Laboratory Abnormalities

    Time frame: Up to 104 weeks

    To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 or 4 laboratory abnormalities.

Sponsors and collaborators

Lead sponsor

Biohaven Therapeutics Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jun 5, 2024
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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