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Long-term Safety and Tolerability of BHV-7000

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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)

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

Trial contacts and locations

219

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Central trial contact

Chief Medical Officer

Data sourced from clinicaltrials.gov

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