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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
Must not have
History of status epilepticus or repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures cannot be counted.
History of focal aware non-motor seizures only, non-epileptic psychogenic seizure, primary generalized seizure, developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal 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.
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.
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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had uncountable seizures or status epilepticus in the last year.
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I have a history of specific types of seizures or syndromes like Lennox-Gastaut.
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I do not have seizures caused by substance use, infections, cancer, or other listed conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
64 Previous Clinical Trials
14,429 Total Patients Enrolled
Medical DirectorStudy DirectorXenon Pharmaceuticals Inc.
2,882 Previous Clinical Trials
8,088,786 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
~51 spots leftby Apr 2025
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