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XEN1101 for Epilepsy (X-TOLE Trial)

Phase 2
Waitlist Available
Research Sponsored by Xenon Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (8 weeks prior to day 0) through to the final dose (up to day 56)
Awards & highlights

X-TOLE Trial Summary

This trial will test if XEN1101 is an effective and safe treatment for focal epilepsy in adults. The trial will be double-blind, meaning neither the patients nor the researchers will know who is receiving the real treatment or the placebo. There will also be an optional open-label extension, meaning that at the end of the trial, patients who wish to can receive the real treatment.

Who is the study for?
Adults with a diagnosis of focal epilepsy for at least 2 years, BMI ≤40 kg/m2, on stable doses of 1-3 approved AEDs can join. They must have had prior neuroimaging and be able to keep seizure diaries. Exclusions include history of certain non-focal seizures, recent neurosurgery, psychotic disorders or suicide risk, significant medical conditions like long QT syndrome or cancer within the past two years.Check my eligibility
What is being tested?
The trial is testing XEN1101 as an additional treatment for focal epilepsy in adults. It's a randomized study where patients either get XEN1101 or a placebo without knowing which one they're getting. After that phase, there's an optional part where everyone gets XEN1101.See study design
What are the potential side effects?
Possible side effects are not detailed here but generally could include typical drug reactions such as skin rashes (like Stevens-Johnson syndrome), blood issues (hematological reactions), organ toxicity, and other medication-related allergies.

X-TOLE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (8 weeks prior to day 0) through to the final dose (up to day 56)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (8 weeks prior to day 0) through to the final dose (up to day 56) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To assess the efficacy of XEN1101 compared to placebo on focal seizure frequency (e.g., median percent change in focal seizure frequency) in adults with focal epilepsy taking 1-3 antiepileptic drugs (AEDs) in the double-blind treatment period (DBP)
To assess the safety and tolerability of XEN1101 (e.g., adverse events) in adults with focal epilepsy taking 1-3 AEDs
Secondary outcome measures
To evaluate the 50% XEN1101 response rates in comparison to placebo in the DBP
To evaluate trends in focal seizure frequency over time in the DBP

X-TOLE Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: 25 mg XEN1101Experimental Treatment1 Intervention
Capsule filled with 25 mg XEN1101
Group II: 20 mg XEN1101Experimental Treatment1 Intervention
Capsule filled with 20 mg XEN1101
Group III: 10 mg XEN1101Experimental Treatment1 Intervention
Capsule filled with 10 mg XEN1101
Group IV: PlaceboPlacebo Group1 Intervention
Placebo capsule

Find a Location

Who is running the clinical trial?

NCGS, Inc.Industry Sponsor
1 Previous Clinical Trials
297 Total Patients Enrolled
Novotech Health Holdings Pte. Ltd.UNKNOWN
Xenon Pharmaceuticals Inc.Lead Sponsor
17 Previous Clinical Trials
2,572 Total Patients Enrolled
3 Trials studying Epilepsy
896 Patients Enrolled for Epilepsy

Media Library

XEN1101 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03796962 — Phase 2
Epilepsy Research Study Groups: 10 mg XEN1101, 25 mg XEN1101, 20 mg XEN1101, Placebo
Epilepsy Clinical Trial 2023: XEN1101 Highlights & Side Effects. Trial Name: NCT03796962 — Phase 2
XEN1101 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03796962 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do you have an age limit for participants in this clinical trial?

"The age range for patients that are being enrolled in this study is between 18 to 75 years old."

Answered by AI

Has XEN1101 completed the necessary steps for FDA approval?

"Given that XEN1101 is still in Phase 2 clinical trials, there is not yet enough data to support its efficacy. However, the available evidence does suggest that it is a safe medication."

Answered by AI

How can I sign up to be a part of this research?

"This trial will have 300 participants that suffer from gelastic epilepsy and are between 18-75 years old. The most crucial requirements for potential patients include: a BMI lower or equal to 40 kg/m2, being on a stable dose of 1-3 current AEDs for at least one month prior to screening and throughout the duration of the study, being willing to comply with contraception requirements, and having the ability to keep accurate seizure diaries."

Answered by AI

How many facilities are participating in this research project?

"The trial is based in The University of Texas Health Science Center at San Antonio (San Antonio, TX), Northwestern Medical Group, Department of Neurology(Chicago, IL) and the University of Kansas Medical Center (Kansas City, KS). There are also 67 other locations where this study is taking place."

Answered by AI

Are we currently enrolling individuals for this research project?

"The most recent information available on clinicaltrials.gov suggests that this particular trial is not actively recruiting patients at the moment. It was initially posted on January 30th, 2019 but has not seen any updates since August 18th, 2020. There are 249 other studies currently looking for participants if you are interested in taking part in medical research."

Answered by AI

Who else is applying?

What site did they apply to?
The Neurology Research Group, LLC.
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I have tried all epileptic drugs for focal seizures but am still searching for a good combination of medicine to control my seizures.
PatientReceived 2+ prior treatments
~53 spots leftby Mar 2025