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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Biohaven Therapeutics Ltd.
Study ID
NCT06309966
Phase
PHASE2/PHASE3
Status
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

Start date
May 13, 2024
Status verified
Apr 2026
Primary completion
May 31, 2026
Completion
May 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 ]

Central Contacts

Locations (65)

FacilityCityStateZIPSite coordinators
Accel ResearchBirminghamAlabama35244-
Onyx Clinical TrialsPeoriaArizona85381-
ARENSIA Exploratory MedicinePhoenixArizona85015
Corina Lugo
602-693-1183
University of Arizona / Banner University Medical Center PhoenixPhoenixArizona85006-
Xenoscience, Inc.PhoenixArizona85004
Derek Soto
602-274-9500
Clinical Trials, Inc.Little RockArkansas72205-
Amicis Research CenterLancasterCalifornia93534-
Memorialcare Miller Children's & Women's Hospital Long BeachLong BeachCalifornia90806-
Tri Valley Neurology Medical Associates, Inc.Mission HillsCalifornia91345-
Stanford UniversityPalo AltoCalifornia94304-
Profound Research LLCPowayCalifornia92065
April Tenorio
760-732-0557
Kaiser PermanenteAuroraColorado80011-
UConn HealthFarmingtonConnecticut06030-
Children's National Medical CenterWashington D.C.District of Columbia20010-
EZR Research, LLCBoca RatonFlorida33486-
Nova Clinical Research, LLCBradentonFlorida34209-
Las Mercedes Medical ResearchHialeahFlorida33012-
Coral Clinic ResearchHomesteadFlorida33032-
Dm HealthworksKissimmeeFlorida34741-
Serenity Research CenterMiamiFlorida33176
Fernando Roa
786-558-4823
Y&L Advance Health Care, Inc d/b/a Elite Clinical ResearchMiamiFlorida33144
Yalexis Lorenzo
305-262-3396
Comprehensive Neurology ClinicOrlandoFlorida32825
Elliuz Leal
407-208-0708
Research Institute of OrlandoOrlandoFlorida32806
Michelle Clevenger
407-652-6011
Panhandle Research & Medical ClinicPensacolaFlorida32502-
Knight NeurologyRockledgeFlorida32955
Joseph Hilde
855-564-4484
PENSTampaFlorida33609-
Encore Medical Research of Weston LLC.WestonFlorida33331-
Accelerated Clinical Trials, LLCPeachtree CornersGeorgia30071-
Bluegrass Epilepsy ResearchLexingtonKentucky40504-
DelRicht ResearchBaton RougeLouisiana70810
Danielle Bryant
225-412-0316
OLORMCBaton RougeLouisiana70808-
Neurocare Of LouisianaCovingtonLouisiana70433-
DelRicht ResearchNew OrleansLouisiana70119
Reggie Mister
504-336-2667
University Medical Center New OrleansNew OrleansLouisiana70112
Heather Scuderi
504-702-4624
LSU Health ShreveportShreveportLouisiana71103
Erin Yates
318-675-7596
Johns Hopkins UniversityBaltimoreMaryland21287
Pamela Coe
410-502-5570
Boston Clinical TrialsBostonMassachusetts02131
Joanne Monaghan
617-477-4868
Boston Neuro ResearchSouth DartmouthMassachusetts02747-
SRI InternationalPlymouthMichigan48170-
University of Missouri Health CareColumbiaMissouri65212-
Somnos Clinical ResearchLincolnNebraska68510
Wendy Bradford
281-973-2030
NEREGHackensackNew Jersey07601-
Tekton ResearchMarlboroNew Jersey07746-
Dent Neurosciences Research CenterAmherstNew York14226-
Northwell HealthGreat NeckNew York11021
Ayesha Rehman
516-428-6136
Northwell Health Ped. NeurologyNew Hyde ParkNew York11042-
NYU Langone HealthNew YorkNew York10016
Mariana Figuera Losada
646-558-0844
Montefiore Medical CenterThe BronxNew York10467-
UNC-Chapel HillChapel HillNorth Carolina27514-
Cincinatti Children's HospitalCincinnatiOhio45229-
Premier HealthDaytonOhio45409-
Oregon Neurology AssociatesSpringfieldOregon97477-
AHNPittsburghPennsylvania15212
Megan Hendricks
412-359-6010
MUSCCharlestonSouth Carolina29425
Robin Bulgarino
843-792-1115
WR-ClinSearchChattanoogaTennessee37421-
Le Bonheur Children's HospitalMemphisTennessee38103
Kerry Moore
901-287-5760
Horizon Clinical Research GroupCypressTexas77429-
M3 Wake Research-DallasDallasTexas75246-
ANESC ResearchEl PasoTexas79912
Shruti Konda
915-974-2200
Tarrant Neurology AssociatesFort WorthTexas76104-
UTHealth HoustonHoustonTexas77030
Maria Poblete
713-500-7201
UTHSCHoustonTexas77030-
Stryde ResearchPlanoTexas75093-
Intermountain HealthMurrayUtah84107
Lindsay Bosh
801-507-4759
Medstar Health Research InstituteMcLeanVirginia22101
Emma Merrill
202-877-3296

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