A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Xenon Pharmaceuticals Inc.
Study ID
NCT05716100
Phase
PHASE3
Status
Recruiting
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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-TOLE3 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
May 9, 2023
Status verified
May 2026
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

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

Central Contacts

Locations (19)

FacilityCityStateZIPSite coordinators
Clinical Trials, Inc.Little RockArkansas72205-
Rancho Research InstituteDowneyCalifornia90242-
University of California Los Angeles (UCLA)Los AngelesCalifornia90095-
University of California Irvine HealthOrangeCalifornia92868-
Panhandle Research and Medical ClinicGulf BreezeFlorida32651-
Mayo Clinic FloridaJacksonvilleFlorida32224-
Consultants in Epilepsy and Neurology, PLLCBoiseIdaho83702-
Southern Illinois University School of MedicineSpringfieldIllinois62794-
Mid-Atlantic Epilepsy and Sleep CenterBethesdaMaryland20817-
9D University Health CenterDetroitMichigan48201-
Northeast Regional Epilepsy GroupHackensackNew Jersey07601-
Five Towns Neuroscience ResearchWoodmereNew York11598-
Duke University ClinicDurhamNorth Carolina27705-
Cleveland ClinicClevelandOhio44195-
OhioHealthColumbusOhio43214-
Providence Neurological SpecialitiesPortlandOregon97225-
Vanderbilt University Medical CenterNashvilleTennessee37232-
Austin Epilepsy Care CenterAustinTexas78758-
University of Utah Clinical Neurosciences CenterSalt Lake CityUtah84132-

Find similar trials in Little Rock, AR

By research site
Clinical Trials, Inc.· Little Rock, ARRancho Research Institute· Downey, CAUniversity of California Los Angeles (UCLA)· Los Angeles, CAUniversity of California Irvine Health· Orange, CAPanhandle Research and Medical Clinic· Gulf Breeze, FLMayo Clinic Florida· Jacksonville, FL

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