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

Sponsored by Xenon Pharmaceuticals Inc.

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...

Current Status

Recruiting

Auto-verified from ClinicalTrials.gov

Verified Feb 3, 2026

Phase

Clinical Trial

Sponsor

Xenon Pharmaceuticals Inc.

Enrollment Target

360

Start Date

May 2023

๐Ÿ“Š
1 of 360 participants interested
0% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

Inclusion Criteria

Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study
Diagnosis (โ‰ฅ2 years) of focal epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy (2017). Subject must have had adequate trials of at least 2 ASMs, which were given (and tolerated) at adequate therapeutic doses, without achieving sustained seizure freedom.
Treatment with a stable dose of 1 to 3 allowable current ASMs for at least one month prior to screening, during baseline, and throughout the duration of the DBP
Able to keep accurate seizure diaries

Exclusion Criteria

Previously documented electroencephalogram which shows any pattern not consistent with focal etiology of seizures.
History of focal aware non-motor seizures only, non-epileptic psychogenic seizure, primary generalized seizure, developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome.
Seizures se

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

๐Ÿ“‹

Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

360 participants

โšง

Gender

ALL

๐Ÿข

Sponsor

Xenon Pharmaceuticals Inc.

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Little Rock

Arkansas

Location available
View Little Rock location page
RECRUITING

Downey

California

Location available
View Downey location page
RECRUITING

Los Angeles

California

Location available
View Los Angeles location page
RECRUITING

Orange

California

Location available
View Orange location page
RECRUITING

Gulf Breeze

Florida

Location available
View Gulf Breeze location page
RECRUITING

Jacksonville

Florida

Location available
View Jacksonville location page
RECRUITING

Boise

Idaho

Location available
View Boise location page
RECRUITING

Springfield

Illinois

Location available
View Springfield location page
RECRUITING

Bethesda

Maryland

Location available
View Bethesda location page

๐Ÿ“ And 8 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

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๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Find More Epilepsy Trials by City

Browse all epilepsy clinical trials in these cities โ€” not just this study.

Looking for Epilepsy Treatment in Downey?

Join others in California exploring innovative treatment options through clinical research

Epilepsy Treatment Options in Downey, California

If you're searching for Epilepsy treatment in Downey, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Downey, Orange, Springfield and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Epilepsy. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 360 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Epilepsy?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Epilepsy

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Epilepsy Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05716100. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.