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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Biohaven Therapeutics Ltd.
Study ID
NCT06132893
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Focal Epilepsy

Eligibility Criteria

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

Interventions

  • BHV-7000 — DRUG
    BHV-7000 25 mg. Participants will take blinded investigational product (IP) once daily
  • BHV-7000 — DRUG
    BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily
  • Placebo — DRUG
    Matching placebo taken once daily
  • BHV-7000 — DRUG
    BHV-7000 75 mg. Participants willtake 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
Mar 14, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: BHV-7000 25 mg Part A
  • Experimental: BHV-7000 50 mg Part A
  • Placebo Comparator: Placebo Part A
  • Experimental: BHV-7000 75 mg Part B
  • Placebo Comparator: Placebo Part B

Primary Outcome Measure

Part B: Change from Baseline in 28-day average seizure frequency [ Time Frame: Baseline, Week 8 to Week 20 of Part B ]

Central Contacts

Locations (61)

FacilityCityStateZIPSite coordinators
Barrow Neurological InstitutePhoenixArizona85013
Caitlin Goodman
[email protected]
602-406-6262
Center for NeurosciencesTucsonArizona85718
Rudolph Phillips
[email protected]
520-795-0229
Clinical Trials, Inc.Little RockArkansas72205
Mark Franks
[email protected]
501-227-6179
WRNRogersArkansas72758-
University of California San DiegoLa JollaCalifornia92041
Jonathan Rodriguez
[email protected]
University of California, Los AngelesLos AngelesCalifornia90095
Sucheta Waghmare
[email protected]
310-794-1195
Stanford Health CarePalo AltoCalifornia94304
Jordan Selinger
[email protected]
650-460-9260
Profound Research LLCPasadenaCalifornia91105
Isabel Canas
[email protected]
213-222-7740
University of Colorado Anschultz Medical CampusAuroraColorado80045
Chris Mizenko
[email protected]
720-848-8621
Yale School of Medicine - Yale-New Haven HospitalNew HavenConnecticut06519-
EZR Research LLCBoca RatonFlorida33486
Olivia Campbell
[email protected]
561-788-7545
Nova Clinical Research, LLCBradentonFlorida34209
Showkat Hossain
[email protected]
941-792-6564
University of Florida (Jacksonville)JacksonvilleFlorida32209
Yasmeen Shabbir
[email protected]
904-244-9856
Floridian Research InstituteMiamiFlorida33179-
University of MiamiMiamiFlorida33136
Anabela Cieslicki
[email protected]
305-243-6732
AdventHealth OrlandoOrlandoFlorida32804-
Medsol Clinical Research CenterPort CharlotteFlorida33952
Maria Vasconcelos
[email protected]
941-623-9744
Santos Research CenterTampaFlorida33615
Liz Santos
[email protected]
813-249-9100
Encore Medical Research of Weston LLC.WestonFlorida33331
Antonio Barreiro
[email protected]
954-777-8827
Pediatrix Medical Group of FloridaWinter ParkFlorida32789-
Augusta UniversityAugustaGeorgia30912
Josh West
[email protected]
706-721-9680
Hawaii Pacific NeuroscienceHonoluluHawaii96817
Kore Liow
[email protected]
808-564-6141
Consultants in Epilepsy & Neurology, PLLCBoiseIdaho83702
Lisa Gravett
[email protected]
208-275-8585
Northwestern UniversityChicagoIllinois60611
Elizabeth Cunningham
[email protected]
312-926-6562
Revive Research Institute, Inc.ElginIllinois60123
Sikar Grewal
[email protected]
847-497-0421
AccellacareAmesIowa50010-
Bluegrass Epilepsy ResearchLexingtonKentucky40504
Morgan Medley
[email protected]
859-313-4989
MAESCBethesdaMaryland20817
Salman Hashmi
[email protected]
301-530-9744
JavaraSilver SpringMaryland20901-
Revive Research Institute, Inc.Rochester HillsMichigan48307-
Minnesota Epilepsy Group, P.A.RosevilleMinnesota55113
Sarah Ellis
[email protected]
651-377-8319
Washington University School of MedicineSt LouisMissouri63110
Patty Schaefer
[email protected]
314-362-7871
NEREGHackensackNew Jersey07601
Hardik Rana
[email protected]
551-497-5000
Inst of NeurologyLivingstonNew Jersey07039
Malik Munazza
[email protected]
973-322-7425
Dent Neurosciences Research CenterAmherstNew York14226
Hailley Pearson
[email protected]
716-250-7002
BCHPHawthorneNew York10532
Donika Zogejani
[email protected]
914-768-8225
Icahn School of Medicine at Mt. SinaiNew YorkNew York10029-
Northwell HealthNew YorkNew York10021
Ronnie Elsaadany
[email protected]
201-988-6177
Stony Brook MedicineStony BrookNew York11794
Christine Pol
[email protected]
631-444-9083
Five Towns Neuroscience ResearchWoodmereNew York11598
Eric Garcia
[email protected]
516-239-1800
OnSite Clinical SolutionsCharlotteNorth Carolina28211-
AccellacareMooresvilleNorth Carolina28117-
Wake Forest BaptistWinston-SalemNorth Carolina27157
Carolyn Hedrick
[email protected]
336-716-8694
NeuroScience Research CenterCantonOhio44718
Shandell Mooney
[email protected]
330-244-2542
University of CincinnatiCincinnatiOhio45267
Lucy Mendoza
[email protected]
513-558-3020
OSUColumbusOhio43214
Elizabeth Wiley
[email protected]
614-293-3660
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107
Emily Patunas
[email protected]
215-503-3213
University of PennsylvaniaPhiladelphiaPennsylvania19104
Melissa Johnston Esparza
[email protected]
215-614-0520
UPMCPittsburghPennsylvania15213-
Vanderbilt University Medical CenterNashvilleTennessee37232
Melissa Osborn
[email protected]
615-322-8817
Clinical Research Solutions LLCCypressTexas77433-
Neurology Consultants of Dallas, PADallasTexas75243
J. Christina Howell
[email protected]
214-750-9977
Tarrant Neurology ConsultantsFort WorthTexas76104
Jamie Hill
[email protected]
817-336-3968
Michael E. DeBakey VA Medical CenterHoustonTexas77030-
Road Runner Research, LtdSan AntonioTexas78249
Lori Santana
[email protected]
210-949-0505
UT Health San AntonioSan AntonioTexas78229
Samantha Lewis
[email protected]
210-450-7370
University of UtahSalt Lake CityUtah84132
Austin Strebel
[email protected]
801-585-9266
UVM MCBurlingtonVermont05401-
University of VirginiaCharlottesvilleVirginia22903
Stacy Thompson
[email protected]
434-982-4315
Henrico Doctors Neurology Associates, LLCRichmondVirginia23235
Gwendolyn Darby
[email protected]
804-288-2742
Carilion ClinicRoanokeVirginia24011
Kristina Cooper
[email protected]
540-224-5856

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