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

Part of paid clinical trials in Peoria, Arizona.

Sponsor
Biohaven Therapeutics Ltd.
Study ID
NCT06309966
Phase
PHASE2/PHASE3
Status
Active Not Recruiting

Conditions

  • Focal Epilepsy

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • BHV-7000 — DRUG
    BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily
  • BHV-7000 — DRUG
    BHV-7000 75 mg. Participants will take blinded investigational product (IP) once daily
  • Placebo — DRUG
    Matching placebo taken once daily

Study Details

The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.

Key Dates

First listed
Mar 13, 2024
Start date
May 13, 2024
Status verified
Jun 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
390 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BHV-7000 50 mg
  • Experimental: BHV-7000 75 mg
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change from Baseline in 28-day average seizure frequency [ Time Frame: Baseline, Week 8 to Week 16 ]

Locations (50)

FacilityCityStateZIPSite coordinators
Onyx Clinical TrialsPeoriaArizona85381-
ARENSIA Exploratory MedicinePhoenixArizona85015-
University of Arizona / Banner University Medical Center PhoenixPhoenixArizona85006-
Xenoscience, Inc.PhoenixArizona85004-
Clinical Trials, Inc.Little RockArkansas72205-
Tri Valley Neurology Medical Associates, Inc.Mission HillsCalifornia91345-
Profound Research LLCPowayCalifornia92065-
UConn HealthFarmingtonConnecticut06030-
Nova Clinical Research, LLCBradentonFlorida34209-
Las Mercedes Medical ResearchHialeahFlorida33012-
Coral Clinic ResearchHomesteadFlorida33032-
Serenity Research CenterMiamiFlorida33176-
Y&L Advance Health Care, Inc d/b/a Elite Clinical ResearchMiamiFlorida33144-
Comprehensive Neurology ClinicOrlandoFlorida32825-
Research Institute of OrlandoOrlandoFlorida32806-
Panhandle Research & Medical ClinicPensacolaFlorida32502-
Knight NeurologyRockledgeFlorida32955-
Encore Medical Research of Weston LLC.WestonFlorida33331-
Accelerated Clinical Trials, LLCPeachtree CornersGeorgia30071-
Bluegrass Epilepsy ResearchLexingtonKentucky40504-
DelRicht ResearchBaton RougeLouisiana70810-
Neurocare Of LouisianaCovingtonLouisiana70433-
DelRicht ResearchNew OrleansLouisiana70119-
University Medical Center New OrleansNew OrleansLouisiana70112-
LSU Health ShreveportShreveportLouisiana71103-
Johns Hopkins UniversityBaltimoreMaryland21287-
Boston Clinical TrialsBostonMassachusetts02131-
Boston Neuro ResearchSouth DartmouthMassachusetts02747-
SRI InternationalPlymouthMichigan48170-
University of Missouri Health CareColumbiaMissouri65212-
Somnos Clinical ResearchLincolnNebraska68510-
NEREGHackensackNew Jersey07601-
Tekton ResearchMarlboroNew Jersey07746-
Dent Neurosciences Research CenterAmherstNew York14226-
Northwell HealthGreat NeckNew York11021-
NYU Langone HealthNew YorkNew York10016-
Montefiore Medical CenterThe BronxNew York10467-
Premier HealthDaytonOhio45409-
Oregon Neurology AssociatesSpringfieldOregon97477-
AHNPittsburghPennsylvania15212-
MUSCCharlestonSouth Carolina29425-
Le Bonheur Children's HospitalMemphisTennessee38103-
Horizon Clinical Research GroupCypressTexas77429-
M3 Wake Research-DallasDallasTexas75246-
ANESC ResearchEl PasoTexas79912-
UTHealth HoustonHoustonTexas77030-
UTHSCHoustonTexas77030-
Stryde ResearchPlanoTexas75093-
Intermountain HealthMurrayUtah84107-
Medstar Health Research InstituteMcLeanVirginia22101-

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