Long-term Safety and Tolerability of BHV-7000

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Biohaven Therapeutics Ltd.
Study ID
NCT06443463
Phase
PHASE2
Status
Enrolling By Invitation

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 open-label investigational product (IP) once daily
  • BHV-7000 — DRUG
    BHV-7000 75 mg. Participants will take open-label investigational product (IP) once daily

Study Details

A study to determine if BHV- 7000 is safe and tolerable in adults with refractory focal onset epilepsy

Key Dates

Start date
Jul 30, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
660 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs [ Time Frame: Up to 104 weeks ]

Locations (115)

FacilityCityStateZIPSite coordinators
Accel ResearchBirminghamAlabama35244-
Onyx Clinical TrialsPeoriaArizona85381-
ARENSIA Exploratory MedicinePhoenixArizona85015-
Barrow Neurological InstitutePhoenixArizona85013-
University of Arizona / Banner University Medical Center PhoenixPhoenixArizona85006-
Xenoscience, Inc.PhoenixArizona85004-
Center for NeurosciencesTucsonArizona85718-
Clinical Trials, Inc.Little RockArkansas72205-
WRNRogersArkansas72758-
University of California San DiegoLa JollaCalifornia92041-
Amicis Research CenterLancasterCalifornia93534-
Memorialcare Miller Children's & Women's Hospital Long BeachLong BeachCalifornia90806-
University of California, Los AngelesLos AngelesCalifornia90095-
Tri Valley Neurology Medical Associates, Inc.Mission HillsCalifornia91345-
Stanford UniversityPalo AltoCalifornia94304-
Profound Research LLCPasadenaCalifornia91105-
Profound Research LLCPowayCalifornia92065-
Kaiser PermanenteAuroraColorado80011-
University of Colorado Anschultz Medical CampusAuroraColorado80045-
UConn HealthFarmingtonConnecticut06030-
Yale School of Medicine - Yale-New Haven HospitalNew HavenConnecticut06519-
EZR Research LLCBoca RatonFlorida33486-
Nova Clinical Research, LLCBradentonFlorida34209-
Las Mercedes Medical ResearchHialeahFlorida33012-
Coral Clinic ResearchHomesteadFlorida33032-
University of Florida (Jacksonville)JacksonvilleFlorida32209-
Dm HealthworksKissimmeeFlorida34741-
Floridian Research InstituteMiamiFlorida33179-
Serenity Research CenterMiamiFlorida33176-
University of MiamiMiamiFlorida33136-
Y&L Advance Health Care, Inc d/b/a Elite Clinical ResearchMiamiFlorida33144-
AdventHealth OrlandoOrlandoFlorida32804-
Comprehensive Neurology ClinicOrlandoFlorida32825-
Research Institute of OrlandoOrlandoFlorida32806-
Panhandle Research & Medical ClinicPensacolaFlorida32502-
Medsol Clinical Research CenterPort CharlotteFlorida33952-
Knight NeurologyRockledgeFlorida32955-
PENSTampaFlorida33609-
Santos Research CenterTampaFlorida33615-
Encore Medical Research of Weston LLC.WestonFlorida33331-
Pediatrix Medical Group of FloridaWinter ParkFlorida32789-
Augusta UniversityAugustaGeorgia30912-
Accelerated Clinical Trials, LLCPeachtree CornersGeorgia30071-
Hawaii Pacific NeuroscienceHonoluluHawaii96817-
Consultants in Epilepsy & Neurology, PLLCBoiseIdaho83702-
Northwestern UniversityChicagoIllinois60611-
Revive Research Institute, Inc.ElginIllinois60123-
McFarland ClinicAmesIowa50010-
Bluegrass Epilepsy ResearchLexingtonKentucky40504-
DelRicht ResearchBaton RougeLouisiana70810-
OLOLRMCBaton RougeLouisiana70808-
Neurocare Of LouisianaCovingtonLouisiana70433-
DelRicht ResearchNew OrleansLouisiana70119-
University Medical Center New OrleansNew OrleansLouisiana70112-
LSU Health ShreveportShreveportLouisiana71103-
John Hopkins UniversityBaltimoreMaryland21287-
Mid-Atlantic Epilepsy & Sleep Center, LLCBethesdaMaryland20817-
JavaraSilver SpringMaryland20901-
Boston Clinical TrialsBostonMassachusetts02131-
Boston Neuro ResearchSouth DartmouthMassachusetts02747-
SRI InternationalPlymouthMichigan48170-
Revive Research Institute, Inc.Rochester HillsMichigan48307-
Minnesota Epilepsy Group, P.A.RosevilleMinnesota55113-
University of Missouri Health CareColumbiaMissouri65212-
Washington University School of MedicineSt LouisMissouri63110-
Somnos Clinical ResearchLincolnNebraska68510-
NEREGHackensackNew Jersey07601-
Inst of NeurologyLivingstonNew Jersey07039-
Tekton ResearchMarlboroNew Jersey07746-
Jersey Shore Medical CenterNeptune CityNew Jersey07753-
Dent Neurosciences Research CenterAmherstNew York14226-
Northwell HealthGreat NeckNew York11021-
BCHPHawthorneNew York10532-
Northwell HealthNew Hyde ParkNew York11042-
NYUNew YorkNew York10016-
NYU Langone HealthNew YorkNew York10016-
Stony Brook MedicineStony BrookNew York11794-
Montefiore Medical CenterThe BronxNew York10467-
Five Towns Neuroscience ResearchWoodmereNew York11598-
UNC-Chapel HillChapel HillNorth Carolina27514-
OnSite Clinical SolutionsCharlotteNorth Carolina28211-
AccellacareMooresvilleNorth Carolina28117-
Wake Forest BaptistWinston-SalemNorth Carolina27157-
NeuroScience Research CenterCantonOhio44718-
University of CincinnatiCincinnatiOhio45267-
OSUColumbusOhio43214-
Premier HealthDaytonOhio45409-
Oregon Neurology AssociatesSpringfieldOregon97477-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
AHNPittsburghPennsylvania15212-
UPMCPittsburghPennsylvania15213-
MUSCCharlestonSouth Carolina29425-
WR-ClinSearchChattanoogaTennessee37421-
Le Bonheur Children's HospitalMemphisTennessee38103-
Vanderbilt University Medical CenterNashvilleTennessee37232-
Clinical Research Solutions LLCCypressTexas77433-
Horizon Clinical Research GroupCypressTexas77429-
M3 Wake Research-DallasDallasTexas75246-
Neurology Consultants of Dallas, PADallasTexas75243-
ANESC ResearchEl PasoTexas79912-
Tarrant Neurology ConsultantsFort WorthTexas76104-
Michael E. DeBakey VA Medical CenterHoustonTexas77030-
UTHealth HoustonHoustonTexas77030-
UTHSCHoustonTexas77030-
Stryde ResearchPlanoTexas75093-
Road Runner Research, LtdSan AntonioTexas78249-
UT Health San AntonioSan AntonioTexas78229-
Intermountain HealthMurrayUtah84107-
University of UtahSalt Lake CityUtah84132-
UVM MCBurlingtonVermont05401-
University of VirginiaCharlottesvilleVirginia22903-
Medstar Health Research InstituteMcLeanVirginia22101-
Henrico Doctors Neurology Associates, LLCRichmondVirginia23235-
Carilion ClinicRoanokeVirginia24011-

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