A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures

Part of paid clinical trials in Mobile, Alabama.

Sponsor
Xenon Pharmaceuticals Inc.
Study ID
NCT05667142
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Primary Generalized Tonic-Clonic Seizures

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • XEN1101 — DRUG
    XEN1101 capsules
  • Placebo — DRUG
    Placebo capsules

Study Details

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in primary generalized tonic-clonic seizures (PGTCS).

Key Dates

Start date
Feb 14, 2023
Status verified
Jun 2026
Primary completion
Apr 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: XEN1101 25 mg/day
    XEN1101 25 mg/day
  • Experimental: XEN1101 15 mg/day
    XEN1101 15 mg/day
  • Placebo Comparator: Placebo
    Placebo

Primary Outcome Measure

Median percent change (MPC) in monthly (28 days) PGTCS frequency [ Time Frame: Baseline through DBP (Week 12) ]

Central Contacts

Locations (59)

FacilityCityStateZIPSite coordinators
University of Alabama - Strada Patient Care Center, NeurologyMobileAlabama36604-
XenosciencePhoenixArizona85004-
University of Arizona - Health Science CenterTucsonArizona85724-
University of Arkansas for Medical SciencesLittle RockArkansas72205-
Brain Science Research InstituteLos AngelesCalifornia90025-
University of California, Irvine - Health Neurology ServicesOrangeCalifornia92868-
University California, Davis Clinical & Translation Science Center Clinical Research (CCRC)SacramentoCalifornia95817-
University of Colorado Anschutz Medical CampusAuroraColorado80045-
Mayo Clinic FloridaJacksonvilleFlorida32224-
Serenity Research Center, LLCMiamiFlorida33176-
Research Institute of Orlando, LLCOrlandoFlorida32806-
Panhandle Research and Medical ClinicPensacolaFlorida32503-
Medsol Clinical Research Center Harbor Professional CentrePort CharlotteFlorida33952-
University of South FloridaTampaFlorida33606-
Encore Medical Research of Weston, LLCWestonFlorida33331-
Children's Healthcare of AtlantaAtlantaGeorgia30342-
Emory Brain Health CenterAtlantaGeorgia30329-
Georgia Neurology & Sleep Medicine AssociatesSuwaneeGeorgia30024-
Hawaii Pacific Neuroscience, Comprehensive Epilepsy CenterHonoluluHawaii96817-
Consultants in Epilepsy and Neurology, PLLCBoiseIdaho83702-
Southern Illinois University School of MedicineSpringfieldIllinois62794-
Indiana University School of MedicineIndianapolisIndiana46202-
University of Kansas Medical CenterKansas CityKansas66160-
Bluegrass Epilepsy Research, LLCLexingtonKentucky40504-
University of Kentucky Albert B. Chandler Hospital (UK Healthcare)LexingtonKentucky40536-
MedStar Franklin Square Medical CenterBaltimoreMaryland21237-
University of Maryland Medical CenterBaltimoreMaryland21201-
Mid-Atlantic Epilepsy and Sleep CenterBethesdaMaryland20817-
Medstar Georgetown University HospitalClintonMaryland20735-
Brigham and Women's HospitalChestnut HillMassachusetts02467-
UMass Memorial Medical CenterWorcesterMassachusetts01655-
University of Michigan HospitalsAnn ArborMichigan48109-
Wayne State UniversityDetroitMichigan48201-
Michigan State University Department of NeurologyEast LansingMichigan48824-
Spectrum HealthGrand RapidsMichigan49503-
Saint Louis University Medical SchoolSt LouisMissouri14624-
Northeast Regional Epilepsy GroupHackensackNew Jersey07601-
Dent Neurosciences Research FacilityAmherstNew York14226-
SUNY Upstate Medical UniversitySyracuseNew York13201-
Five Towns NeurologyWoodmereNew York11598-
Atrium HealthCharlotteNorth Carolina28203-
Onsite Clinical Solutions, LLCCharlotteNorth Carolina28211-
Duke University Clinical ResearchDurhamNorth Carolina27710-
Wake Forest Baptist HealthWinston-SalemNorth Carolina27104-
Summa Health Clinical Research CenterAkronOhio44304-
Cleveland Clinic FoundationClevelandOhio44195-
OhioHealth Riverside Methodist HospitalColumbusOhio43214-
The Ohio State UniversityColumbusOhio43210-
Temple University HospitalPhiladelphiaPennsylvania19140-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
UPMC Comprehensive Epilepsy CenterPittsburghPennsylvania15213-
Medical University of South Carolina (MUSC)CharlestonSouth Carolina29425-
ANESC ResearchEl PasoTexas79912-
UTHealth Science Center at HoustonHoustonTexas77030-
University of Texas Health Science Center at San AntonioSan AntonioTexas78229-
University of Utah Clinical Neurosciences CenterSalt Lake CityUtah84132-
Sentara Neurology SpecialistsVirginia BeachVirginia23456-
University of Washington, Regional Epilepsy Center at Harborview Medical CenterSeattleWashington98104-
Advocate Aurora Research institute, St. Luke's Medical CenterMilwaukeeWisconsin53215-

Find similar trials in Mobile, AL

By research site
University of Alabama - Strada Patient Care Center, Neurology· Mobile, ALXenoscience· Phoenix, AZUniversity of Arizona - Health Science Center· Tucson, AZUniversity of Arkansas for Medical Sciences· Little Rock, ARBrain Science Research Institute· Los Angeles, CAUniversity of California, Irvine - Health Neurology Services· Orange, CA