A Phase 2/3 interventional study of BHV-7000 and BHV-7000 in Focal Epilepsy, sponsored by Biohaven Therapeutics Ltd.. Active, not recruiting at 104 sites in 12 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Biohaven Therapeutics Ltd. · Phase 2/3, Interventional, and Treatment
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
This study has two parts, Part A and Part B. Part A is randomized 1:1:1 25 mg of BHV-7000, 50 mg of BHV-7000 or matching placebo. Part B is randomized 1:1 75mg BHV-7000 or matching placebo. Part B will start after Part A.
243 studies on the registry are indexed under Epilepsies, Partial; 49 are open to participants now.
This study's planned enrollment of 390 is above the median of 90 across 187 interventional studies indexed under Epilepsies, Partial.
Browse Epilepsies, Partial studies →Biohaven Therapeutics Ltd. is the lead sponsor of 20 studies on the registry; 9 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Diagnosis of Focal Onset Epilepsy at least 1 year prior to screening visit defined by 2017 International League Against Epilepsy (ILAE) Classification and based on requirements of Epilepsy Adjudication criteria.
a. Focal seizures i. Focal aware seizures with clinically observable signs and/or symptoms ii. Focal impaired awareness seizures iii. Focal to bilateral tonic-clonic seizures
Key Exclusion Criteria:
Drug: BHV-7000
Drug: BHV-7000
Drug: Placebo
Drug: BHV-7000
Drug: Placebo
BHV-7000 25 mg. Participants will take blinded investigational product (IP) once daily
BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily
Matching placebo taken once daily
BHV-7000 75 mg. Participants willtake blinded investigational product(IP) once daily
Matching placebo taken once daily
Part B: Change from Baseline in 28-day average seizure frequency
To compare the efficacy of each of 2 doses of BHV-7000 to placebo as an adjunctive therapy for refractory focal onset epilepsy as measured by the change from OP (observational phase) in 28-day average seizure frequency. The primary objective will be measured by comparing the observation phase (8 weeks) to the 12-week double-blind treatment phase.
Time frame: 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
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.
Time frame: Week 8 to Week 20 of Part A
Part A: Number of Participants 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.
Time frame: Week 8 to Week 20 of Part A
Part B: Percentage of Participants with at at least 50% reduction in seizure frequency per month
To compare the efficacy of 2 dose strengths of BHV-7000 to placebo as adjunctive therapy for refractory focal onset epilepsy as measured by the proportion of subjects that have at least a 50% reduction in seizures per month (28 days). This objective will be measured by comparing the proportion of subjects with at least a 50% reduction in 28-day average seizure frequency over the course of the 12 week double-blind phase to the observation phase.
Time frame: Baseline, Week 8 to Week 20 of Part B
Part B: Change from Baseline in 28-day average seizure frequency during first month of treatment
To compare the efficacy of BHV-7000 to placebo during the first month of treatment. This objective will be measured by the change in log-transformed 28-day adjusted seizure frequency from observation phase over the first month of the double blind phase.
Time frame: Baseline, Week 8 to Week 12 of Part B
Part B: Percentage of Participants with at at least 75% reduction in seizure frequency per month
To compare the efficacy of BHV-7000 to placebo as measured by the proportion of subjects that have at least a 75% reduction in seizures per month (28 days). This objective will be measured by comparing the proportion of subjects with at least a 75% reduction in 28-day average seizure frequency over the course of the double-blind phase compared to the observation phase.
Time frame: Baseline, Week 8 to Week 20 of Part B
Part B: Percentage of Participants with seizure freedom during DB Phase
To compare the efficacy of BHV-7000 to placebo on seizure freedom (100% seizure reduction during the DB phase). This objective will be measured by proportion of subjects that are seizure free during the double-blind phase.
Time frame: Week 8 to Week 20 of Part B
Part B: Change from baseline in 7-day adjusted seizure frequency during first week of treatment
To compare the efficacy of BHV-7000 to placebo during the first week of treatment. This objective will be measured by the change in log-transformed 7-day adjusted seizure frequency from observation phase over the first week of the double-blind phase.
Time frame: Baseline, Week 8 to Week 9 of Part B
Part B: Change from baseline in Patient Global Impression of Change (PGI-C)
To compare the efficacy of BHV-7000 to placebo on the patient global impression of change (PGI-C). This objective will be measured by proportion of subjects at week 12 of double-blind treatment phase with a PGI-C response of "minimally improved", "much improved" or "very much improved". This scale is a 7-point Likert scale with response options of: (1) "very much improved" , (2) "much improved", (3) "minimally improved", (4) "no change", (5) "minimally worse", (6) "much worse", (7) and "very much worse"
Time frame: Baseline, Week 20 of Part B
Part B: 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.
Time frame: Week 8 to Week 20 of Part B
Part B: Number of Participants 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.
Time frame: Week 8 to Week 20 of Part B
Showing the first 100 of 104 sites across 12 countries. Choose a country and city above to see the rest.
Started Mar 2024 (actual). Primary completion is estimated for Dec 2026, 33 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Biohaven Therapeutics Ltd.