A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Xenon Pharmaceuticals Inc.
Study ID
NCT03796962
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Focal Epilepsy

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The XEN1101 Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of increasing doses of XEN1101 administered as adjunctive treatment in adult patients diagnosed with focal epilepsy, followed by an optional open-label extension (OLE).

Key Dates

Start date
Jan 30, 2019
Status verified
Sep 2024
Primary completion
Sep 2, 2021
Completion
Oct 31, 2028

Study Design

Enrollment
325 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 25 mg XEN1101
    Capsule filled with 25 mg XEN1101
  • Experimental: 20 mg XEN1101
    Capsule filled with 20 mg XEN1101
  • Experimental: 10 mg XEN1101
    Capsule filled with 10 mg XEN1101
  • Placebo Comparator: Placebo
    Placebo capsule

Primary Outcome Measure

Median Percent Change in Focal Seizure Frequency [ Time Frame: From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56) ]

Locations (54)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
Strada Patient Care CenterMobileAlabama36604-
Xenoscience, Inc.PhoenixArizona85004-
Clinical Trials, Inc.Little RockArkansas72205-
Altman Clinical Translational Research Institute (ACTRI)La JollaCalifornia92037-
California Pacific Medical Center (CPMC) - Sutter Pacific Epilepsy ProgramSan FranciscoCalifornia94109-
University of Colorado Hospital Anschutz Outpatient PavilionAuroraColorado80045-
Mayo Clinic FloridaJacksonvilleFlorida32224-
University of Florida JacksonvilleJacksonvilleFlorida32209-
Don Clinical Research CenterMiamiFlorida33136-
The Neurology Research Group, LLC.MiamiFlorida33176-
Visionary Investigators NetworkMiamiFlorida33133-
Research Institute of Orlando, LLCOrlandoFlorida32806-
Medsol Clinical Research CenterPort CharlotteFlorida33952-
Tallahassee Neurological ClinicTallahasseeFlorida32308-
University of South FloridaTampaFlorida33606-
Georgia Neurology and Sleep Medicine AssociateSuwaneeGeorgia30024-
Hawaii Pacific NeuroscienceHonoluluHawaii96817-
Consultants in Epilepsy and Neurology, PLLCBoiseIdaho83702-
Northwestern Medical Group, Department of NeurologyChicagoIllinois60611-
University of Kansas Medical CenterKansas CityKansas66160-
Bluegrass Epilepsy ResearchLexingtonKentucky40504-
Maine Medical Partners NeurologyScarboroughMaine04074-
Mid-Atlantic Epilepsy and Sleep CenterBethesdaMaryland20817-
Boston Neuro Research CenterSouth DartmouthMassachusetts02747-
Minneapolis Clinic of Neurology, Ltd.Golden ValleyMinnesota55422-
Minnesota Epilepsy Group, P. A.Saint PaulMinnesota55102-
Northeast Regional Epilepsy GroupHackensackNew Jersey07601-
Institute of Neurology and Neurosurgery at Saint BarnabasLivingstonNew Jersey07039-
Northeast Regional Epilepsy GroupMorristownNew Jersey07960-
Dent Neurosciences Research CenterAmherstNew York14226-
Northwell Health - Lenox HillNew YorkNew York10075-
NYU Langone Medical Center/NYU School of MedicineNew YorkNew York10016-
SUNY Upstate Medical University Institute for Human PerformanceSyracuseNew York13210-
Five Towns Neuroscience ResearchWoodmereNew York11598-
Asheville Neurology Specialists, PAAshevilleNorth Carolina28806-
UC Gardner Neuroscience InstituteCincinnatiOhio45219-
Miami Valley HospitalDaytonOhio45409-
University of Toledo Medical CenterToledoOhio43606-
Providence Neurological Specialties EastPortlandOregon97213-
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104-
Thomas Jefferson University Comprehensive Epilepsy CenterPhiladelphiaPennsylvania19107-
Allegheny Neurological AssociatesPittsburghPennsylvania15212-
Vanderbilt Epilepsy ClinicNashvilleTennessee37232-
Austin Epilepsy Care CenterAustinTexas78758-
James W. Aston Ambulatory Care CenterDallasTexas75390-
The University of Texas Health Science Center at San AntonioSan AntonioTexas78229-3900-
University of Utah Health Clinical Neurosciences CenterSalt Lake CityUtah84132-
University of VirginiaCharlottesvilleVirginia22903-
Virginia Commonwealth UniversityRichmondVirginia23219-
Carilion Neurology ClinicRoanokeVirginia24016-
Winchester Neurological ConsultantsWinchesterVirginia22601-
UW Medicine Valle Medical CenterRentonWashington98055-
University of Washington School of Medicine, Regional Epilepsy Center at Harborview Medical CenterSeattleWashington98104-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALStrada Patient Care Center· Mobile, ALXenoscience, Inc.· Phoenix, AZClinical Trials, Inc.· Little Rock, ARAltman Clinical Translational Research Institute (ACTRI)· La Jolla, CACalifornia Pacific Medical Center (CPMC) - Sutter Pacific Epilepsy Program· San Francisco, CA

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