Long-term Safety and Tolerability of BHV-7000

Focal Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06443463
• Other study ID #: BHV7000-201
• Secondary ID: 2023-508813-18-0
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2024
• Est. completion date: January 2027

Study information

• Verified date: June 2024
• Source: Biohaven Pharmaceuticals, Inc.
• Contact: Chief Medical Officer
• Phone: 203-404-0410
• Email: clinicaltrials[@]biohavenpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 660
• Est. completion date: January 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• Focal Epilepsy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biohaven Therapeutics Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs	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.	Up to 52 weeks
Primary	Number of Subjects with Clinically Significant Laboratory Abnormalities	To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 and 4 laboratory abnormalities.	Up to 52 weeks