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XEN1101 for Seizures (X-TOLE2 Trial)

Phase 3
Recruiting
Research Sponsored by Xenon Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening through to 56 days post-final dose.
Awards & highlights

X-TOLE2 Trial Summary

This trial will test a new drug to treat seizures, to see if it's safe, effective and tolerated.

Who is the study for?
This trial is for individuals diagnosed with focal epilepsy for at least 2 years, who have tried at least two anti-seizure medications without success. Participants must be on a stable dose of 1 to 3 permitted seizure medicines and able to maintain accurate seizure diaries. It's not suitable for those with seizures due to other health issues or substance use, or those who've had recent neurosurgery.Check my eligibility
What is being tested?
The X-TOLE2 Phase 3 study tests the effectiveness and safety of XEN1101 as an additional treatment for focal-onset seizures compared to a placebo. Participants are randomly assigned to receive either XEN1101 or a placebo in addition to their current seizure medications.See study design
What are the potential side effects?
While specific side effects of XEN1101 are not listed here, common side effects from similar epilepsy treatments can include dizziness, fatigue, coordination problems, nausea, and potential skin rashes. Each person may experience side effects differently.

X-TOLE2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been on 1 to 3 approved seizure medications for at least a month.

X-TOLE2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening through to 56 days post-final dose.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening through to 56 days post-final dose. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Median percent change (MPC) in monthly (28 days) focal seizure frequency from baseline to DBP for XEN1101 versus placebo.
Secondary outcome measures
MPC in weekly (7 days) focal seizure frequency from baseline to Week 1 for XEN1101 versus placebo.
Proportion of subjects experiencing "at least much improved" (including "much" and "very much improved") in Patient Global Impression of Change (PGI-C).
Seizures
+1 more

X-TOLE2 Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: XEN1101 25 mg/dayExperimental Treatment1 Intervention
XEN1101 25 mg/day
Group II: XEN1101 15 mg/dayExperimental Treatment1 Intervention
XEN1101 15 mg/day
Group III: PlaceboPlacebo Group1 Intervention
Placebo

Find a Location

Who is running the clinical trial?

Xenon Pharmaceuticals Inc.Lead Sponsor
17 Previous Clinical Trials
2,555 Total Patients Enrolled
Worldwide Clinical TrialsOTHER
61 Previous Clinical Trials
14,027 Total Patients Enrolled
Medical DirectorStudy DirectorXenon Pharmaceuticals Inc.
2,777 Previous Clinical Trials
8,063,859 Total Patients Enrolled

Media Library

XEN1101 25 mg/day Clinical Trial Eligibility Overview. Trial Name: NCT05614063 — Phase 3
Partial Seizures Research Study Groups: Placebo, XEN1101 25 mg/day, XEN1101 15 mg/day
Partial Seizures Clinical Trial 2023: XEN1101 25 mg/day Highlights & Side Effects. Trial Name: NCT05614063 — Phase 3
XEN1101 25 mg/day 2023 Treatment Timeline for Medical Study. Trial Name: NCT05614063 — Phase 3

Frequently Asked Questions

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

Are there any available spots in this experiment for participants?

"As per clinicaltrials.gov, this study is actively recruiting patients and has been amended since its initial posting on November 18th 2022. The listing was most recently updated on December 12th 2022."

Answered by AI

Is the current enrollment process accepting individuals aged 75 and above?

"This trial is open to patients aged 18-75. For those under the age of 18 and over 65, there are 39 and 63 clinical trials respectively that may be suitable."

Answered by AI

What is the population size of this clinical experiment?

"Confirmed. Information accessible on clinicaltrials.gov confirms that this research is currently seeking applicants, and was first made available 18th of November 2022 with the latest updates posted 12th December 2022. The trial necessitates 360 individuals spread across two sites for complete enrolment."

Answered by AI

What potential safety risks are associated with XEN1101 taken at 25 mg/day?

"Our experts at Power assessed XEN1101 25 mg/day's safety to be a 3 due to the presence of multiple rounds of data and evidence that corroborates its efficacy."

Answered by AI

Are there certain criteria a person must meet in order to qualify for this research?

"This clinical trial seeks to enrol 360 individuals, aged 18-75, who have been diagnosed with focal epilepsy according to the 2017 ILAE Classification of Epilepsy. Additionally, participants must be currently taking 1-3 allowable antiseizure medications for at least one month prior to screening and throughout the duration of the study; they also need to agree in writing that they understand its nature and risks before commencing by signing an informed consent form."

Answered by AI

Who else is applying?

What site did they apply to?
Austin Epilepsy Care Center (AECC)
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I have tried multiple medications.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long is screening? How often are check ups?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures
2022. "A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05614063.
All > Meridian > Honolulu
~141 spots leftby Apr 2025
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