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RISE 2: A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy

Sponsor
Biohaven Therapeutics Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06132893
Collaborator
(none)
390
Enrollment
34
Locations
3
Arms
21
Anticipated Duration (Months)
11.5
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
390 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2025
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: BHV-7000 25 mg

Drug: BHV-7000
BHV-7000 25 mg. Participants will take blinded investigational product (IP) once daily
Active Comparator: BHV-7000 50 mg

Drug: BHV-7000
BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily
Placebo Comparator: Placebo

Drug: Placebo
Matching placebo taken once daily

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline in 28-day average seizure frequency during Weeks 8 to 20 of Treatment [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Male and Female participants 18 to 75 years of age at time of consent.

  2. 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.

  1. 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

  1. 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.

  2. Ability to keep accurate seizure diaries

  3. 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:

  1. 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.

  2. History of repetitive/cluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit and during observation phase.

  3. Resection neurosurgery for seizures <4 months prior to the screening visit.

  4. Radiosurgery performed <2 years prior to the screening visit.

  5. 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.

  6. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Center for Neurosciences Tucson Arizona United States 85718
2 WRN Rogers Arkansas United States 72758
3 University of California San Diego La Jolla California United States 92041
4 Profound Research LLC Pasadena California United States 91105
5 EZR Research LLC Boca Raton Florida United States 33486
6 Nova Clinical Research, LLC Bradenton Florida United States 34209
7 University of Florida (Jacksonville) Jacksonville Florida United States 32209
8 University of Miami Miami Florida United States 33136
9 Floridian Research Institute Miami Florida United States 33179
10 Santos Research Center Tampa Florida United States 33615
11 Encore Medical Research of Weston LLC. Weston Florida United States 33331
12 Augusta University Augusta Georgia United States 30912
13 Consultants in Epilepsy & Neurology, PLLC Boise Idaho United States 83702
14 Northwestern University Chicago Illinois United States 60611
15 Revive Research Institute, Inc. Elgin Illinois United States 60123
16 Accellacare Ames Iowa United States 50010
17 Bluegrass Epilepsy Research Lexington Kentucky United States 40504
18 MAESC Bethesda Maryland United States 20817
19 Javara Silver Spring Maryland United States 20901
20 Revive Research Institute, Inc. Rochester Hills Michigan United States 48307
21 NEREG Hackensack New Jersey United States 07601
22 Inst of Neurology Livingston New Jersey United States 07039
23 Dent Neurosciences Research Center Amherst New York United States 14226
24 Northwell Health New York New York United States 10021
25 Icahn School of Medicine at Mt. Sinai New York New York United States 10029
26 Five Towns Neuroscience Research Woodmere New York United States 11598
27 OnSite Clinical Solutions Charlotte North Carolina United States 28211
28 NeuroScience Research Center Canton Ohio United States 44718
29 Vanderbilt University Medical Center Nashville Tennessee United States 37232
30 Clinical Research Solutions LLC Cypress Texas United States 77433
31 Neurology Consultants of Dallas, PA Dallas Texas United States 75243
32 Michael E. DeBakey VA Medical Center Houston Texas United States 77030
33 Road Runner Research, Ltd San Antonio Texas United States 78249
34 University of Virginia Charlottesville Virginia United States 22903

Sponsors and Collaborators

  • Biohaven Therapeutics Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Biohaven Therapeutics Ltd.
ClinicalTrials.gov Identifier:
NCT06132893
Other Study ID Numbers:
  • BHV7000-302
  • 2023-508539-30-00
First Posted:
Nov 15, 2023
Last Update Posted:
Nov 23, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Biohaven Therapeutics Ltd.
Focal Epilepsy
Epilepsy
Seizure
Refractory Epilepsy
Partial Epilepsy
Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial

Study Results

No Results Posted as of Nov 23, 2023