Focal Epilepsy Clinical Trial
— RISE 2Official 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
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
| Status | Recruiting |
| Enrollment | 390 |
| Est. completion date | September 2025 |
| Est. primary completion date | August 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | 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. 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 3. 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. 4. Ability to keep accurate seizure diaries 5. 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Accellacare | Ames | Iowa |
| United States | Dent Neurosciences Research Center | Amherst | New York |
| United States | Augusta University | Augusta | Georgia |
| United States | University of Colorado Anschultz Medical Campus | Aurora | Colorado |
| United States | MAESC | Bethesda | Maryland |
| United States | EZR Research LLC | Boca Raton | Florida |
| United States | Consultants in Epilepsy & Neurology, PLLC | Boise | Idaho |
| United States | Nova Clinical Research, LLC | Bradenton | Florida |
| United States | UVM MC | Burlington | Vermont |
| United States | NeuroScience Research Center | Canton | Ohio |
| United States | OnSite Clinical Solutions | Charlotte | North Carolina |
| United States | University of Virginia | Charlottesville | Virginia |
| United States | Northwestern University | Chicago | Illinois |
| United States | University of Cincinnati | Cincinnati | Ohio |
| United States | OSU | Columbus | Ohio |
| United States | Clinical Research Solutions LLC | Cypress | Texas |
| United States | Neurology Consultants of Dallas, PA | Dallas | Texas |
| United States | Revive Research Institute, Inc. | Elgin | Illinois |
| United States | NEREG | Hackensack | New Jersey |
| United States | BCHP | Hawthorne | New York |
| United States | Hawaii Pacific Neuroscience | Honolulu | Hawaii |
| United States | Michael E. DeBakey VA Medical Center | Houston | Texas |
| United States | University of Florida (Jacksonville) | Jacksonville | Florida |
| United States | University of California San Diego | La Jolla | California |
| United States | Bluegrass Epilepsy Research | Lexington | Kentucky |
| United States | Clinical Trials, Inc. | Little Rock | Arkansas |
| United States | Inst of Neurology | Livingston | New Jersey |
| United States | University of California, Los Angeles | Los Angeles | California |
| United States | Floridian Research Institute | Miami | Florida |
| United States | University of Miami | Miami | Florida |
| United States | Accellacare | Mooresville | North Carolina |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Icahn School of Medicine at Mt. Sinai | New York | New York |
| United States | Northwell Health | New York | New York |
| United States | AdventHealth Orlando | Orlando | Florida |
| United States | Profound Research LLC | Pasadena | California |
| United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
| United States | University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | Barrow Neurological Institute | Phoenix | Arizona |
| United States | Medsol Clinical Research Center | Port Charlotte | Florida |
| United States | Henrico Doctors Neurology Associates, LLC | Richmond | Virginia |
| United States | Revive Research Institute, Inc. | Rochester Hills | Michigan |
| United States | WRN | Rogers | Arkansas |
| United States | Minnesota Epilepsy Group, P.A. | Roseville | Minnesota |
| United States | Road Runner Research, Ltd | San Antonio | Texas |
| United States | UT Health San Antonio | San Antonio | Texas |
| United States | Javara | Silver Spring | Maryland |
| United States | Stony Brook Medicine | Stony Brook | New York |
| United States | Santos Research Center | Tampa | Florida |
| United States | Center for Neurosciences | Tucson | Arizona |
| United States | Encore Medical Research of Weston LLC. | Weston | Florida |
| United States | Pediatrix Medical Group of Florida | Winter Park | Florida |
| United States | Five Towns Neuroscience Research | Woodmere | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Biohaven Therapeutics Ltd. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from Baseline in 28-day average seizure frequency during Weeks 8 to 20 of Treatment | 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02245061 -
Cortical Excitability Assessment Using Paired Pulses
|
N/A | |
| Terminated |
NCT05081518 -
A Study of Lu AG06466 in Participants With Treatment Resistant Focal Epilepsy
|
Phase 1 | |
| Withdrawn |
NCT05481905 -
ENACT: A Study of ENX-101 as Adjunctive Treatment in Patients With Focal Seizures
|
Phase 2 | |
| Completed |
NCT02208492 -
The Effects on Cognitive Function of Levetiracetam (Keppra®) Compared to Carbamazepine (Tegretol®, Carmazepine®) as Monotherapy for Children With Partial Seizure; A Multicentric Randomized Controlled Study
|
Phase 4 | |
| Recruiting |
NCT04839601 -
RNS System RESPONSE Study
|
N/A | |
| Completed |
NCT02898935 -
Improvement of the Accuracy of Spatial Representation of Invasive Exploratory Electrodes in Focal Epilepsy
|
||
| Enrolling by invitation |
NCT05748236 -
The Efficacy and Safety of Lamotrigine Versus Carbamazepine in Focal Epilepsy
|
Phase 4 | |
| Terminated |
NCT01724918 -
Lacosamide IV and EEG/EKG (LIVE) Study
|
Phase 2 | |
| Completed |
NCT00855738 -
A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice
|
Phase 4 | |
| Not yet recruiting |
NCT06210022 -
Cognitive Impairment in Drug-resistant and Drug-responsive Focal Cryptogenic Epilepsy
|
||
| Completed |
NCT01311440 -
Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy
|
N/A | |
| Terminated |
NCT03955432 -
Long-term Cardiac Monitoring in Epilepsy
|
N/A | |
| Recruiting |
NCT05100771 -
Optimized Volumetry in Radiology: Interest in Pediatric Brain MRI in the Exploration of Focal Epilepsy
|
||
| Recruiting |
NCT04879433 -
Prospective Open-label Evaluation of Cenobamate Adjunctive Treatment of Adults With Refractory Focal Epilepsy
|
||
| Active, not recruiting |
NCT03916848 -
Novel Network Analysis of Intracranial Stereoelectroencephalography
|
N/A | |
| Recruiting |
NCT05198882 -
Clinical Evaluation of Interstitial Laser Thermal Therapy Under Continuous MRI Monitoring as a Minimally Invasive Treatment of Patients With Medically Unbalanced Partial Epilepsy
|
Phase 1 | |
| Recruiting |
NCT05981755 -
Breathing Rescue for SUDEP Prevention
|
N/A | |
| Recruiting |
NCT03457961 -
Post-market Study of AMPA Receptor Antagonists for Epilepsy Patients in Hong Kong
|
||
| Completed |
NCT03082222 -
ZEDEBAC: Zebinix Effects in Dependency of Baseline Conditions
|
||
| Completed |
NCT02126774 -
The Human Epilepsy Project
|