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XEN1101 for Partial Seizures

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
Seizures secondary to drug or alcohol use, ongoing infection, neoplasia, demyelinating disease, degenerative neurological disease, metabolic illness, progressive structural lesion, encephalopathy, or progressive central nervous system (CNS) disease.
History of status epilepticus or repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures cannot be counted.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial

Summary

This trial will study if a drug (XEN1101) lessens the severity/frequency of seizures in people with focal-onset seizures.

Who is the study for?
This trial is for adults with focal epilepsy diagnosed at least 2 years ago, who've tried and not responded to at least two anti-seizure medications (ASMs). They must be on a stable dose of 1-3 ASMs currently. Participants need to provide informed consent, have no history of certain non-focal seizures or neurosurgery within specific time frames, and can't have seizures from other medical conditions.
What is being tested?
The X-TOLE3 study tests the effectiveness and safety of XEN1101 as an additional treatment for focal-onset seizures compared to a placebo. It's randomized (participants are assigned by chance) and double-blind (neither participants nor researchers know who gets what), ensuring unbiased results.
What are the potential side effects?
While the side effects of XEN1101 aren't specified here, common side effects in seizure medication trials may include dizziness, fatigue, balance issues, gastrointestinal discomfort, mood changes, skin rashes or allergic reactions.

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 do not have seizures caused by substance use, infections, cancer, or other listed conditions.
Select...
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.

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
XEN1101
2021
Completed Phase 2
~50

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
65 Previous Clinical Trials
14,500 Total Patients Enrolled
Xenon Medical DirectorStudy DirectorXenon Pharmaceuticals Inc.

Media Library

XEN1101 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05716100 — Phase 3
Partial Seizures Research Study Groups: XEN1101 15 mg/day, XEN1101 25 mg/day, Placebo
Partial Seizures Clinical Trial 2023: XEN1101 Highlights & Side Effects. Trial Name: NCT05716100 — Phase 3
XEN1101 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05716100 — Phase 3
~83 spots leftby Aug 2025
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