An Open-label Study of XEN1101 in Epilepsy

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Xenon Pharmaceuticals Inc.
Study ID
NCT05718817
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

  • Focal Epilepsy
  • Tonic-Clonic Seizures

Eligibility Criteria

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

Interventions

Study Details

This study will evaluate the long term safety, tolerability, pharmacokinetics (PK), and efficacy of XEN1101 in subjects with Focal Onset Seizures (FOS) or Primary Generalized Tonic-Clonic Seizures (PGTCS) for the treatment of seizures for up to 6 years.

Key Dates

Start date
Apr 25, 2023
Status verified
May 2026
Primary completion
Apr 30, 2033
Completion
Jun 30, 2033

Study Design

Enrollment
880 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: XEN1101 15 or 25 mg/day
    XEN1101 15 or 25 mg/day

Primary Outcome Measure

The adverse events [ Time Frame: From the start of treatment in the open-label extension (OLE) study through 8 weeks after the last dose. ]

Locations (53)

FacilityCityStateZIPSite coordinators
XenosciencePhoenixArizona85004-
University of Arizona - Health SciencesTucsonArizona85724-
Clinical Trials, IncLittle RockArkansas72205-
Brain Science Research InstituteLos AngelesCalifornia90025-
UC Irvine HealthOrangeCalifornia92868-
University of California, Davis Clinical & Translational Science Center Clinical Research (CCRC)SacramentoCalifornia95817-
University of Colorado Hospital Anschutz Outpatient PavilionAuroraColorado80045-
Mayo Clinic FloridaJacksonvilleFlorida32224-
Serenity Research Center, LLCMiamiFlorida33176-
Research Institute of Orlando, LLCOrlandoFlorida32806-
Panhandle Research & Medical ClinicPensacolaFlorida10021-
University of South FloridaTampaFlorida33606-
Encore Medical Research of Weston, LLCWestonFlorida33331-
Hawaii Pacific NeuroscienceHonoluluHawaii96817-
Consultants in Epilepsy and NeurologyBoiseIdaho83704-
Indiana University School of MedicineIndianapolisIndiana46202-
The University of Kansas Medical CenterKansas CityKansas66103-
Bluegrass Epilepsy Research, LLCLexingtonKentucky40504-
Kentucky ClinicLexingtonKentucky40536-
MMP NeurologyScarboroughMaine04074-
University of Maryland Medical CenterBaltimoreMaryland21201-
Mid-Atlantic Epilepsy and Sleep CenterBethesdaMaryland20817-
Brigham and Women's HospitalBostonMassachusetts02115-
UMass Chan Medical SchoolWorcesterMassachusetts06155-
University of Michigan HospitalsAnn ArborMichigan48109-2435-
Wayne State UniversityDetroitMichigan48201-
Michigan State UniversityEast LansingMichigan48824-
Cornwell Health (Spectrum Health Hospitals)Grand RapidsMichigan49503-
Minneapolis Clinic of NeurologyBurnsvilleMinnesota55337-
Saint Louis University Medical SchoolSt LouisMissouri63104-
Northeast Epilepsy GroupHackensackNew Jersey07601-
Dent Neurosciences Research CenterBuffaloNew York14226-
Mount Sinai HealthNew YorkNew York10029-
New York University Comprehensive Epilepsy CenterNew YorkNew York10016-
SUNY Upstate Medical UniversitySyracuseNew York13210-
Montefiiore Medical CenterThe BronxNew York10467-
Onsite Clinical SolutionsCharlotteNorth Carolina28211-
Duke UniversityDurhamNorth Carolina27710-
Meridian Clinical Research, LLCRaleighNorth Carolina27607-
Summa HealthAkronOhio44304-
Cleveland Clinic FoundationClevelandOhio44195-
The Ohio State University Brain and Spine HospitalColumbusOhio43210-
Providence Neurological SpecialitiesPortlandOregon97225-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
Vanderbilt University Medical CenterNashvilleTennessee37232-
Austin Epilepsy Care CenterAustinTexas78758-
ANESC ResearchEl PasoTexas79912-
UT Health San AntonioSan AntonioTexas78229-
University of Utah Clinical Neurosciences CenterSalt Lake CityUtah84132-
Carilion ClinicRoanokeVirginia24013-
Sentara Neurology SpecialistsVirginia BeachVirginia23456-
University of Washington Main HospitalSeattleWashington10012-
Aurora St. Luke's Medical CenterMilwaukeeWisconsin53215-

Find similar trials in Phoenix, AZ

By research site
Xenoscience· Phoenix, AZUniversity of Arizona - Health Sciences· Tucson, AZClinical Trials, Inc· Little Rock, ARBrain Science Research Institute· Los Angeles, CAUC Irvine Health· Orange, CAUniversity of California, Davis Clinical & Translational Science Center Clinical Research (CCRC)· Sacramento, CA

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