RISESHINE · BHV7000-201

A long-term international study designed to monitor the safety and tolerability of the drug BHV-7000 in individuals diagnosed with refractory focal onset epilepsy.

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. EudraCT: 2023-508813-18-00

Sponsor: BIOHAVEN

Phase: II

Status: Follow-up

View clinical trials catalogue

Public study eligibility criteria

Inclusion

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

Exclusion

  • Any condition, such as an ongoing AE with/without sequalae, or is poorly tolerating IP in the DBP 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.