- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06132893
A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy (RISE 2)
A Phase 2/3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of BHV-7000 in Subjects With Refractory Focal Onset Epilepsy
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Chief Medical Officer
- Phone Number: 203-404-0410
- Email: clinicaltrials@biohavenpharma.com
Study Locations
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Arizona
-
Phoenix, Arizona, United States, 85013
- Not yet recruiting
- Barrow Neurological Institute
-
Contact:
- Caitlin Goodman
- Phone Number: 602-406-6262
- Email: Caitlin.Goodman@CommonSpirit.org
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Tucson, Arizona, United States, 85718
- Recruiting
- Center for Neurosciences
-
Contact:
- Rudolph Phillips
- Phone Number: 520-795-0229
- Email: Rphillips@neurotucson.com
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Arkansas
-
Little Rock, Arkansas, United States, 72205
- Recruiting
- Clinical Trials, Inc.
-
Contact:
- Mark Franks
- Phone Number: 501-227-6179
- Email: mafranks@clinicaltrialsinc.com
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Rogers, Arkansas, United States, 72758
- Recruiting
- WRN
-
Contact:
- Tyler Karnes
- Phone Number: 479-927-3000
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California
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La Jolla, California, United States, 92041
- Not yet recruiting
- University of California San Diego
-
Contact:
- Natalia Menendez
- Email: nmenendez@health.ucsd.edu
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Los Angeles, California, United States, 90095
- Not yet recruiting
- University of California, Los Angeles
-
Contact:
- Sucheta Waghmare
- Phone Number: 310-794-1195
- Email: SWaghmare@mednet.ucla.edu
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Pasadena, California, United States, 91105
- Recruiting
- Profound Research LLC
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Contact:
- Isabel Canas
- Phone Number: 213-222-7740
- Email: isabel@profoundresearch.io
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Colorado
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Aurora, Colorado, United States, 80045
- Not yet recruiting
- University of Colorado Anschultz Medical Campus
-
Contact:
- Chris Mizenko
- Phone Number: 720-848-8621
- Email: christopher.mizenko@cuanschutz.edu
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Florida
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Boca Raton, Florida, United States, 33486
- Recruiting
- EZR Research LLC
-
Contact:
- Olivia Campbell
- Phone Number: 561-788-7545
- Email: ocampbell@fcneurology.net
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Bradenton, Florida, United States, 34209
- Recruiting
- Nova Clinical Research, LLC
-
Contact:
- Showkat Hossain
- Phone Number: 941-792-6564
- Email: showkat.hossain@novaclinicalresearch.com
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Jacksonville, Florida, United States, 32209
- Recruiting
- University of Florida (Jacksonville)
-
Contact:
- Yasmeen Shabbir
- Phone Number: 904-244-9856
- Email: yasmeen.shabbir@jax.ufl.edu
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Miami, Florida, United States, 33136
- Recruiting
- University of Miami
-
Contact:
- Anabela Cieslicki
- Phone Number: 305-243-6732
- Email: axc1623@med.miami.edu
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Miami, Florida, United States, 33179
- Recruiting
- Floridian Research Institute
-
Contact:
- Giovanna Fernandez
- Email: gfernandez@floridianresearch.com
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Orlando, Florida, United States, 32804
- Not yet recruiting
- AdventHealth Orlando
-
Contact:
- Tracey Purvis
- Phone Number: 407-906-0515
- Email: Tracey.Purvis@AdventHealth.com
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Port Charlotte, Florida, United States, 33952
- Not yet recruiting
- Medsol Clinical Research Center
-
Contact:
- Maria Vasconcelos
- Phone Number: 941-623-9744
- Email: mvasconcelos@medsolcrc.com
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Tampa, Florida, United States, 33615
- Recruiting
- Santos Research Center
-
Contact:
- Liz Santos
- Phone Number: 813-249-9100
- Email: santosresearchcenter@gmail.com
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Weston, Florida, United States, 33331
- Recruiting
- Encore Medical Research of Weston LLC.
-
Contact:
- Antonio Barreiro
- Phone Number: 954-777-8827
- Email: abarreiro@encoremedicalresearch.com
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Winter Park, Florida, United States, 32789
- Recruiting
- Pediatrix Medical Group of Florida
-
Contact:
- Denise Hubert
- Phone Number: 308126 407-293-1122
- Email: denise.hubert@pediatrix.com
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-
Georgia
-
Augusta, Georgia, United States, 30912
- Recruiting
- Augusta University
-
Contact:
- Josh West
- Phone Number: 706-721-9680
- Email: ctscto@augusta.edu
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Hawaii
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Honolulu, Hawaii, United States, 96817
- Recruiting
- Hawaii Pacific Neuroscience
-
Contact:
- Kore Liow
- Phone Number: 808-564-6141
- Email: kliow@hawaiineuroscience.com
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Idaho
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Boise, Idaho, United States, 83702
- Recruiting
- Consultants in Epilepsy & Neurology, PLLC
-
Contact:
- Lisa Gravett
- Phone Number: 6 208-275-8585
- Email: Lisa@Idahoepilepsy.com
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-
Illinois
-
Chicago, Illinois, United States, 60611
- Not yet recruiting
- Northwestern University
-
Contact:
- Elizabeth Cunningham
- Phone Number: 312-926-6562
- Email: elizabeth.bachman@nm.org
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Elgin, Illinois, United States, 60123
- Recruiting
- Revive Research Institute, Inc.
-
Contact:
- Sikar Grewal
- Phone Number: 847-497-0421
- Email: Grewal@rev-research.com
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-
Iowa
-
Ames, Iowa, United States, 50010
- Recruiting
- Accellacare
-
Contact:
- Erin Hackett
- Phone Number: 515-956-4159
- Email: erin.hackett@accellacare.com
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-
Kentucky
-
Lexington, Kentucky, United States, 40504
- Recruiting
- Bluegrass Epilepsy Research
-
Contact:
- Morgan Medley
- Phone Number: 859-313-4989
- Email: morgan.medley@commonspirit.org
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-
Maryland
-
Bethesda, Maryland, United States, 20817
- Recruiting
- MAESC
-
Contact:
- Salman Hashmi
- Phone Number: 301-530-9744
- Email: hashmis@epilepsydc.com
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Silver Spring, Maryland, United States, 20901
- Recruiting
- Javara
-
Contact:
- Nadine Ridore
- Email: nridore@javararesearch.com
-
-
Michigan
-
Rochester Hills, Michigan, United States, 48307
- Recruiting
- Revive Research Institute, Inc.
-
Contact:
- Sikar Grewal
- Phone Number: 947-217-3229
- Email: Sgrewal@rev-research.com
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Minnesota
-
Roseville, Minnesota, United States, 55113
- Recruiting
- Minnesota Epilepsy Group, P.A.
-
Contact:
- Sarah Ellis
- Phone Number: 651-377-8319
- Email: sellis@mnepilepsy.net
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-
New Jersey
-
Hackensack, New Jersey, United States, 07601
- Recruiting
- NEREG
-
Contact:
- Hardik Rana
- Phone Number: 551-497-5000
- Email: hrana@epilepsygroup.com
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Livingston, New Jersey, United States, 07039
- Recruiting
- Inst of Neurology
-
Contact:
- Malik Munazza
- Phone Number: 973-322-7425
- Email: mmalik@inst-neuro.com
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New York
-
Amherst, New York, United States, 14226
- Recruiting
- Dent Neurosciences Research Center
-
Contact:
- Hailley Pearson
- Phone Number: 716-250-7002
- Email: hpearson@dentinstitute.com
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Hawthorne, New York, United States, 10532
- Not yet recruiting
- BCHP
-
Contact:
- Donika Zogejani
- Phone Number: 914-768-8225
- Email: dzogejan@nymc.edu
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New York, New York, United States, 10029
- Not yet recruiting
- Icahn School of Medicine at Mt. Sinai
-
Contact:
- Onome Eka
- Phone Number: 212-241-8861
- Email: onome.eka@mssm.edu
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New York, New York, United States, 10021
- Recruiting
- Northwell Health
-
Contact:
- Ronnie Elsaadany
- Phone Number: 201-988-6177
- Email: relsaadany@northwell.edu
-
Stony Brook, New York, United States, 11794
- Recruiting
- Stony Brook Medicine
-
Contact:
- Christine Pol
- Phone Number: 631-444-9083
- Email: Christiana.pol@stonybrookmedicine.edu
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Woodmere, New York, United States, 11598
- Recruiting
- Five Towns Neuroscience Research
-
Contact:
- Eric Garcia
- Phone Number: 135 516-239-1800
- Email: egarcia@ftniresearch.com
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North Carolina
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Charlotte, North Carolina, United States, 28211
- Recruiting
- Onsite Clinical Solutions
-
Contact:
- Reyna Quesada
- Phone Number: 800-785-3150
- Email: rquesada@onsiteclinical.com
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Mooresville, North Carolina, United States, 28117
- Recruiting
- Accellacare
-
Contact:
- Justice McDonald
- Phone Number: 704-924-2105
- Email: justice.mcdonald@accellacare.com
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-
Ohio
-
Canton, Ohio, United States, 44718
- Recruiting
- NeuroScience Research Center
-
Contact:
- Shandell Mooney
- Phone Number: 330-244-2542
- Email: shandellm@neurocarecenter.com
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Cincinnati, Ohio, United States, 45267
- Not yet recruiting
- University of Cincinnati
-
Contact:
- Lucy Mendoza
- Phone Number: 513-558-3020
- Email: Lucy.Mendoza@uc.edu
-
Columbus, Ohio, United States, 43214
- Not yet recruiting
- OSU
-
Contact:
- Elizabeth Wiley
- Phone Number: 614-293-3660
- Email: elizabeth.wiley@osumc.edu
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Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Not yet recruiting
- Thomas Jefferson University
-
Contact:
- Emily Patunas
- Phone Number: 215-503-3213
- Email: emily.patunas@jefferson.edu
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Philadelphia, Pennsylvania, United States, 19104
- Not yet recruiting
- University of Pennsylvania
-
Contact:
- Melissa Johnston Esparza
- Phone Number: 215-614-0520
- Email: melissa.johnstonesparza@pennmedicine.upenn.edu
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-
Tennessee
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Nashville, Tennessee, United States, 37232
- Not yet recruiting
- Vanderbilt University Medical Center
-
Contact:
- Melissa Osborn
- Phone Number: 615-322-8817
- Email: melissa.osborn@vumc.org
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-
Texas
-
Cypress, Texas, United States, 77433
- Recruiting
- Clinical Research Solutions LLC
-
Contact:
- Rakhshinda Javaid
- Phone Number: 281-357-5678
- Email: rjavaid@clinicalrs.com
-
Dallas, Texas, United States, 75243
- Recruiting
- Neurology Consultants of Dallas, PA
-
Contact:
- J. Christina Howell
- Phone Number: 293 214-750-9977
- Email: jchowell@neurologydallas.com
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Houston, Texas, United States, 77030
- Not yet recruiting
- Michael E. DeBakey VA Medical Center
-
Contact:
- Zulfi Haneef
- Phone Number: 713-794-7201
- Email: haneef.zulfi@va.gov
-
San Antonio, Texas, United States, 78229
- Not yet recruiting
- UT Health San Antonio
-
Contact:
- Samantha Lewis
- Phone Number: 210-450-7370
- Email: Lewiss11@uthscsa.edu
-
San Antonio, Texas, United States, 78249
- Recruiting
- Road Runner Research, Ltd
-
Contact:
- Lori Santana
- Phone Number: 210-949-0505
- Email: lsantana@rrresearchsa.com
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-
Vermont
-
Burlington, Vermont, United States, 05401
- Recruiting
- UVM MC
-
Contact:
- Lisa Smith
- Phone Number: 802-656-9921
- Email: lisa.smith@med.uvm.edu
-
-
Virginia
-
Charlottesville, Virginia, United States, 22903
- Not yet recruiting
- University of Virginia
-
Contact:
- Stacy Thompson
- Phone Number: 434-982-4315
- Email: src2h@uvahealth.org
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Richmond, Virginia, United States, 23235
- Recruiting
- Henrico Doctors Neurology Associates, LLC
-
Contact:
- Gwendolyn Darby
- Phone Number: 804-288-2742
- Email: Gwendolyn.Darby@HCAHealthcare.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male and Female participants 18 to 75 years of age at time of consent.
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.
a. Focal seizures i. Focal aware seizures with clinically observable signs and/or symptoms ii. Focal impaired awareness seizures with clinically observable signs and/or symptoms iii. Focal to bilateral tonic-clonic seizures
- Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used anti-seizure medication (ASM) schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom.
- Ability to keep accurate seizure diaries
- Current treatment with at least 1 and up to 3 ASMs and 4 epilepsy treatments in total (e.g., 3 ASMs + 1 diet regimen; 2 ASMs + 1 diet regimen + 1 device, etc.)
Exclusion Criteria:
- 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 that is not consistent with the subject's habitual seizure.
- History of repetitive/cluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit and during observation phase.
- Resection neurosurgery for seizures <4 months prior to the screening visit.
- Radiosurgery performed <2 years prior to the screening visit.
- 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.
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Matching placebo taken once daily
|
Experimental: BHV-7000 25 mg
|
BHV-7000 25 mg.
Participants will take blinded investigational product (IP) once daily
BHV-7000 50 mg.
Participants will take blinded investigational product (IP) once daily
|
Experimental: BHV-7000 50 mg
|
BHV-7000 25 mg.
Participants will take blinded investigational product (IP) once daily
BHV-7000 50 mg.
Participants will take blinded investigational product (IP) once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in 28-day average seizure frequency during Weeks 8 to 20 of Treatment
Time Frame: Baseline, Week 8 to Week 20
|
To compare the efficacy of each of 2 doses of BHV-7000 to placebo as an adjunctive therapy for refractory focal onset epilepsy as measured by the change from baseline in 28-day average seizure frequency.
The primary objective will be measured by comparing the observation phase (8 weeks) to the 12-week double-blind treatment phase.
|
Baseline, Week 8 to Week 20
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BHV7000-302
- 2023-508539-30-00 (Registry Identifier: EU CTR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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