A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy

Phase 2/3

Recruiting

Conditions: Refractory Focal Onset Epilepsy

Registration Number: 2023-508539-30-00

Lead Sponsor: Biohaven Therapeutics Ltd.

Brief Summary: 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).

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing, recruiting

Sex: Not specified

Target Recruitment: 219

Inclusion Criteria

Signed Written Informed Consent 2. Subject and/or caregiver must be able to read and understand eDiary in an available language. 3. Subjects must be able to swallow the BHV-7000 IP tablet whole. 4. Male and Female subjects 18 to 75 years of age at time of consent 5. Ability to keep accurate seizure diaries and miss no more than 4 entries (daily seizure diary) out of 28 days demonstrating 85% or greater compliance with eDiary during OP. 6. 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. 7. Focal seizures (1) Focal aware seizures with clinically observable signs and/or symptoms (2) Focal impaired awareness seizures with clinically observable signs and/or symptoms (3) Focal to bilateral tonic-clonic seizures 8. Drug Resistant Focal Onset Seizures (1) Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used ASM schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom. 9. Current treatment of no more than 4 epilepsy treatments of which no more than 3 can be ASMs (e.g., 3 ASMs + 1 diet regimen; 2 ASMs + 1 diet regimen + 1 device, etc.). Implanted neurostimulation devices and epilepsy dietary therapy are considered epilepsy treatments in this trial.

Exclusion Criteria

Non-focal seizures defined by ILAE criteria (1) EEG shows any pattern not consistent with focal etiology of seizures (e.g., generalized spike-wave). (2) Subjects with only focal aware nonmotor seizures which involve subjective sensory or psychic phenomena only, without impairment of consciousness or awareness (formally called simple partial seizures), with or without ictal EEG correlation with clinical symptoms. (3) Subjects with confirmed generalized onset seizures. 2. History of status epilepticus (convulsive status epilepticus for > 5 minutes or focal status epilepticus with impaired conscious for > 10 minutes) within the last 6 months prior to screening visit. 3. Resection neurosurgery for seizures < 4 months prior to the screening visit. 4. Radiosurgery performed < 2 years prior to the screening visit. 5. Any condition 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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with at least a 50% reduction in 28-day average seizure frequency over the course of the DBP compared to the OP.		Proportion of subjects with at least a 50% reduction in 28-day average seizure frequency over the course of the DBP compared to the OP.

Secondary Outcome Measures

Name	Time	Method
- Change in log-transformed 28-day adjusted seizure frequency from OP over the 12-week DBP. -Change in log-transformed 28-day adjusted seizure frequency from OP over the first month of the DBP.		- Change in log-transformed 28-day adjusted seizure frequency from OP over the 12-week DBP. -Change in log-transformed 28-day adjusted seizure frequency from OP over the first month of the DBP.
- Proportion of subjects with at least a 75% reduction in 28-day average seizure frequency over the course of the DBP compared to the OP. -Proportion of subjects that are seizure free during the DBP. -Change in log-transformed 7-day adjusted seizure frequency from OP over the first week of the DBP.		- Proportion of subjects with at least a 75% reduction in 28-day average seizure frequency over the course of the DBP compared to the OP. -Proportion of subjects that are seizure free during the DBP. -Change in log-transformed 7-day adjusted seizure frequency from OP over the first week of the DBP.
- Proportion of subjects at week 12 with PGI-C response of "minimally improved", "much improved", or "very much improved". -Safety is assessed by the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, moderate and severe AEs and grade 3 and 4 laboratory abnormalities.		- Proportion of subjects at week 12 with PGI-C response of "minimally improved", "much improved", or "very much improved". -Safety is assessed by the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, moderate and severe AEs and grade 3 and 4 laboratory abnormalities.

Trial Locations

Locations (46): Medical University Of Vienna
🇦🇹
Vienna, Austria
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
🇦🇹
Salzburg, Austria
Johannes Kepler University Linz
🇦🇹
Linz, Austria
Noe LGA Gesundheit Region Mitte GmbH
🇦🇹
St. Poelten, Austria
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
🇧🇪
Yvoir, Belgium
Antwerp University Hospital
🇧🇪
Edegem, Belgium
Hopital Erasme
🇧🇪
Anderlecht, Belgium
Universitair Ziekenhuis Gent
🇧🇪
Gent, Belgium
Klinička bolnica Dubrava (University Hospital Dubrava)
🇭🇷
Zagreb, Croatia
Klinička bolnica Sveti Duh (Clinical Hospital „Sveti Duh“)
🇭🇷
Zagreb, Croatia
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Medical University Of Vienna
🇦🇹Vienna, Austria
Ekaterina Pataraia
Site contact
+4314040034330
ekaterina.pataraia@meduniwien.ac.at