A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures

Part of paid clinical trials in Mobile, Alabama.

Sponsor
Xenon Pharmaceuticals Inc.
Study ID
NCT05614063
Phase
PHASE3
Status
Completed

Conditions

  • Focal Onset Seizures

Eligibility Criteria

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

Interventions

  • XEN1101 — DRUG
    XEN1101 Capsules
  • Placebo — DRUG
    Placebo Capsules

Study Details

The X-TOLE2 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive therapy in focal-onset seizures.

Key Dates

Start date
Nov 18, 2022
Status verified
May 2026
Primary completion
Jan 12, 2026
Completion
Feb 3, 2026

Study Design

Enrollment
380 participants (actual)
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) focal seizure frequency from baseline to DBP for XEN1101 versus placebo. [ Time Frame: From baseline through to the double blind period (week 12) ]

Locations (56)

FacilityCityStateZIPSite coordinators
Strada Patient Care CenterMobileAlabama36604-
XenosciencePhoenixArizona85004-
University of Arizona, Health Sciences CenterTucsonArizona85724-
Clinical Trials, IncLittle RockArkansas72205-
Brain Science Research InstituteLos AngelesCalifornia90025-
University of California, David Clinical & Translational Science Center Clinical Research (CCRC)SacramentoCalifornia95817-
Anschutz Health SciencesAuroraColorado80011-
Serenity ResearchMiamiFlorida33176-
Research Institute of Orlando, LLCOrlandoFlorida32806-
Panhandle Research & Medical ClinicPensacolaFlorida32503-
Medsol Clinical Research CenterPort CharlotteFlorida33952-
University of South FloridaTampaFlorida33606-
Encore Medical Research of Weston, LLCWestonFlorida33021-
Emory Brain Health CenterAtlantaGeorgia30329-
Hawaii Pacific NeuroscienceHonoluluHawaii96817-
Consultants in Epilepsy and NeurologyBoiseIdaho83702-
Indiana University, IU Health Partners, Adult Neurology ClinicIndianapolisIndiana46202-
The University of Kansas Medical CenterKansas CityKansas66160-
Bluegrass Epilepsy Research, LLCLexingtonKentucky40504-
University of Kentucky, Dept. of NeurologyLexingtonKentucky40536-0284-
MaineHealth Neurology - ScarboroughScarboroughMaine04074-
Medstar Franklin Square Medical CenterBaltimoreMaryland21237-
University of Maryland Medical CenterBaltimoreMaryland21201-
Mid-Atlantic Epilepsy and Sleep CenterBethesdaMaryland20817-
MedStar Georgetown University HospitalClintonMaryland20735-
Brigham and Women's HospitalBostonMassachusetts02115-
UMass Memorial Medical CenterWorcesterMassachusetts01655-
University of MichiganAnn ArborMichigan48109-
Michigan State UniversityEast LansingMichigan48824-
Cornwell HealthGrand RapidsMichigan49506-
Minneapolis Clinic of NeurologyBurnsvilleMinnesota55337-
Saint Louis University Medical School - Neurosciences Clinical Research UnitSt LouisMissouri63104-
Washington University, St. LouisSt LouisMissouri63110-
Northeast Epilepsy GroupHackensackNew Jersey07601-
Dent Neurosciences Research CenterBuffaloNew York14226-
Mount Sinai Medical CenterNew YorkNew York10029-
NYU Comprehensive Epilepsy Center (CEC)New YorkNew York10016-
Weill Cornell Medicine/ New York-Presbyterian HospitalNew YorkNew York10021-
SUNY Upstate Medical UniversitySyracuseNew York13210-
Montefiore Medical CenterThe BronxNew York10467-2401-
Onsite Clinical Solutions, LLCCharlotteNorth Carolina28211-
Duke NeurologyDurhamNorth Carolina27713-
Meridian Clinical Research, LLCRaleighNorth Carolina27607-
Wake Forest Baptist HealthWinston-SalemNorth Carolina27157-
Summa HealthAkronOhio44304-
Providence Brain & Spine InstitutePortlandOregon97225-
Temple University HospitalPhiladelphiaPennsylvania19140-4105-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
Austin Epilepsy Care Center (AECC)AustinTexas78758-
ANESC ResearchEl PasoTexas79912-
UT Physicians Epilepsy ClinicHoustonTexas77030-
UT Health San AntonioSan AntonioTexas78229-
Carilion Clinic - NeurologyRoanokeVirginia24013-
Sentara Neurology SpecialistsVirginia BeachVirginia23456-
University of Washington Main HospitalSeattleWashington98104-
Aurora St. Luke's Medical CenterMilwaukeeWisconsin53215-

Find similar trials in Mobile, AL

By research site
Strada Patient Care Center· Mobile, ALXenoscience· Phoenix, AZUniversity of Arizona, Health Sciences Center· Tucson, AZClinical Trials, Inc· Little Rock, ARBrain Science Research Institute· Los Angeles, CAUniversity of California, David Clinical & Translational Science Center Clinical Research (CCRC)· Sacramento, CA

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