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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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have been on 1 to 3 approved seizure medications for at least a month.
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 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).
Proportion of subjects experiencing ≥50% reduction in focal seizure frequency from baseline through the DBP for XEN1101 versus placebo.
+1 moreTrial 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
Xenon Medical DirectorStudy DirectorXenon Pharmaceuticals Inc.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.You can accurately keep track of your seizures in a diary.I have had uncountable seizures or status epilepticus in the last year.I had neurosurgery for seizures less than a year ago or radiosurgery less than two years ago.I have focal epilepsy for 2+ years and haven't found seizure control with 2+ medications.I have a history of specific types of seizures or syndromes like Lennox-Gastaut.You had a previous EEG that showed patterns not consistent with the cause of seizures in one specific area of the brain.
Research Study Groups:
This trial has the following groups:- Group 1: XEN1101 15 mg/day
- Group 2: XEN1101 25 mg/day
- Group 3: Placebo
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does ingesting XEN1101 15 mg/day pose any safety risks?
"Our group at Power assigned a score of 3 to XEN1101 15 mg/day, indicating that there is established clinical evidence both for its effectiveness and safety due to the fact it has reached Phase III."
Answered by AI
Approximately how many study participants have enrolled in this research?
"Affirmative. According to information accessible on clinicaltrials.gov, this medical experiment was first published on May 9th 2023 and is actively seeking participants. It requires 360 individuals from 2 different healthcare facilities for completion."
Answered by AI
Are there available vacancies in this trial for prospective participants?
"Yes, the information on clinicaltrials.gov confirms that this study is actively searching for applicants and has been doing so since May 9th 2023. As of July 25th 2023, 360 participants are being sought from two separate sites."
Answered by AI
Who else is applying?
What site did they apply to?
Southern Illinois University School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
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