protocolSection identificationModule nctId: NCT06309966, orgStudyIdInfo id: BHV7000-303, secondaryIdInfos id: 2023-808811-21-00, type: REGISTRY, domain: EU CTR, briefTitle: Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy, acronym: RISE 3, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Biohaven Therapeutics Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy., conditionsModule conditions: Focal Epilepsy, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 390, type: ESTIMATED, armsInterventionsModule interventions name: BHV-7000, interventions name: BHV-7000, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change from Baseline in 28-day average seizure frequency during Weeks 8 to 16 of Treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dm Healthworks, status: NOT_YET_RECRUITING, city: Kissimmee, state: Florida, zip: 34741, country: United States, contacts name: Deeba Ahmad, role: CONTACT, phone: 407-716-1563, email: drdm22@gmail.com, geoPoint lat: 28.30468, lon: -81.41667, locations facility: Y&L Advance Health Care, Inc d/b/a Elite Clinical Research, status: NOT_YET_RECRUITING, city: Miami, state: Florida, zip: 33144, country: United States, contacts name: Yalexis Lorenzo, role: CONTACT, phone: 305-262-3396, email: ylorenzo@eliteclinicalresearch.com, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Research Institute of Orlando, status: NOT_YET_RECRUITING, city: Orlando, state: Florida, zip: 32806, country: United States, contacts name: Michelle Clevenger, role: CONTACT, phone: 407-652-6011, email: Michelle@researchinstituteoforlando.com, geoPoint lat: 28.53834, lon: -81.37924, locations facility: Comprehensive Neurology Clinic, status: NOT_YET_RECRUITING, city: Orlando, state: Florida, zip: 32825, country: United States, contacts name: Elliuz Leal, role: CONTACT, phone: 407-208-0708, email: elealcrc@gmail.com, geoPoint lat: 28.53834, lon: -81.37924, locations facility: Knight Neurology, status: RECRUITING, city: Rockledge, state: Florida, zip: 32955, country: United States, contacts name: Joseph Hilde, role: CONTACT, phone: 855-564-4484, email: jhilde01@knightneurology.com, geoPoint lat: 28.35084, lon: -80.72533, locations facility: PENS, status: RECRUITING, city: Tampa, state: Florida, zip: 33609, country: United States, contacts name: Susan Ngo, role: CONTACT, phone: 813-873-7367, email: sngo@pensresearch.org, geoPoint lat: 27.94752, lon: -82.45843, locations facility: University Medical Center New Orleans, status: NOT_YET_RECRUITING, city: New Orleans, state: Louisiana, zip: 70112, country: United States, contacts name: Heather Scuderi, role: CONTACT, phone: 504-702-4624, email: heather.scuderi@lcmchealth.org, geoPoint lat: 29.95465, lon: -90.07507, locations facility: DelRicht Research, status: NOT_YET_RECRUITING, city: New Orleans, state: Louisiana, zip: 70119, country: United States, contacts name: Reggie Mister, role: CONTACT, phone: 504-336-2667, email: rmister@delricht.com, geoPoint lat: 29.95465, lon: -90.07507, locations facility: UNC-Chapel Hill, status: NOT_YET_RECRUITING, city: Chapel Hill, state: North Carolina, zip: 27514, country: United States, contacts name: Monica Coudurier, role: CONTACT, phone: 919-966-6727, email: m_coudurier@unc.edu, geoPoint lat: 35.9132, lon: -79.05584, locations facility: Cincinatti Children's Hospital, status: NOT_YET_RECRUITING, city: Cincinnati, state: Ohio, zip: 45229, country: United States, contacts name: Nikki Kamos, role: CONTACT, phone: 513-803-4552, email: nichole.kamos@cchmc.org, geoPoint lat: 39.12713, lon: -84.51435, locations facility: MUSC, status: NOT_YET_RECRUITING, city: Charleston, state: South Carolina, zip: 29425, country: United States, contacts name: Robin Bulgarino, role: CONTACT, phone: 843-792-1115, email: bulgarino@musc.edu, geoPoint lat: 32.77657, lon: -79.93092, locations facility: WR-ClinSearch, status: NOT_YET_RECRUITING, city: Chattanooga, state: Tennessee, zip: 37421, country: United States, contacts name: Jessica Benvenuto, role: CONTACT, phone: 423-698-4584, email: jbenvenuto@wakeresearch.com, geoPoint lat: 35.04563, lon: -85.30968, locations facility: ANESC Research, status: NOT_YET_RECRUITING, city: El Paso, state: Texas, zip: 79912, country: United States, contacts name: Shruti Konda, role: CONTACT, phone: 915-974-2200, phoneExt: 3, email: shrutik@anesc.net, geoPoint lat: 31.75872, lon: -106.48693, locations facility: UTHealth Houston, status: NOT_YET_RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Maria Poblete, role: CONTACT, phone: 713-500-7201, email: Maria.Poblete@uth.tmc.edu, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False