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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 belowSelect...
I have been on 1 to 3 approved seizure medications for at least a month.
X-TOLE2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from screening through to 56 days post-final dose.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening through to 56 days post-final dose.
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 moreX-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
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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.
2,789 Previous Clinical Trials
8,066,944 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I had neurosurgery for seizures less than a year ago or radiosurgery less than two years ago.I have had uncountable seizures or status epilepticus in the last year.I have had focal epilepsy for 2+ years and two medications haven't stopped my seizures.I do not have seizures caused by substance use, infections, cancer, or other listed conditions.I have been on 1 to 3 approved seizure medications for at least a month.I have a history of specific types of seizures or syndromes like Lennox-Gastaut.Your previous brain wave test showed patterns that do not match the cause of seizures.You can accurately record information about your seizures in a diary.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: XEN1101 25 mg/day
- Group 3: XEN1101 15 mg/day
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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