A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
NCT06132893 · RISE 2 Phase 2/3Active, not recruiting
- Lead sponsor
- Biohaven Therapeutics Ltd. (Industry)
- Enrollment
- 390 (estimated)
- Start date
- 14 Mar 2024
- Primary completion
- Dec 2026 (estimated)
- Study completion
- 1 Dec 2026
- Last update posted
- 30 Sep 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Sequential
- Masking
- Quadruple
- Arms
- 5
Interventions
- BHV-7000 Drug
- Placebo Drug
Conditions and primary outcome
- Focal Epilepsy
Primary outcome
Part B: Change from Baseline in 28-day average seizure frequency (Baseline, Week 8 to Week 20 of Part B); Part A: Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs (Week 8 to Week 20 of Part A); Part A: Number of Participants With Clinically Significant Laboratory Abnormalities (Week 8 to Week 20 of Part A)
Posted results on ClinicalTrials.gov
Results posted on ClinicalTrials.gov: No
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
No PubMed citation lists NCT06132893.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT06132893 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
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