Your session is about to expire
← Back to Search
Other
XEN1101 for Epilepsy (X-TOLE4 Trial)
Phase 3
Waitlist Available
Research Sponsored by Xenon Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline through the active extension treatment (week 156).
Awards & highlights
X-TOLE4 Trial Summary
This trial will test a drug for treating seizure disorders for 3 years, assessing its safety, tolerability, and effectiveness.
Who is the study for?
This trial is for individuals with Focal Onset Seizures or Primary Generalized Tonic-Clonic Seizures who have completed a previous study without early termination or significant issues. Participants must be able to follow the study's instructions, keep accurate seizure diaries, and provide informed consent.Check my eligibility
What is being tested?
The trial is testing the long-term safety and effectiveness of XEN1101, taken orally once daily at a dose of 25 mg. It aims to treat seizures in patients with certain types of epilepsy over a period of up to three years.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions related to XEN1101 throughout the course of treatment, focusing on its tolerability and any potential impact on seizure control.
X-TOLE4 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline through the active extension treatment (week 156).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline through the active extension treatment (week 156).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The adverse events
Secondary outcome measures
Change in Clinical Global Impression of Severity (CGI-S)
Change in Patient Global Impression of Severity (PGI-S)
Change in Quality of Life in Epilepsy Inventory (QOLIE-31)
+2 moreX-TOLE4 Trial Design
1Treatment groups
Experimental Treatment
Group I: XEN1101 25 mg/dayExperimental Treatment1 Intervention
XEN1101 25 mg/day
Find a Location
Who is running the clinical trial?
Xenon Pharmaceuticals Inc.Lead Sponsor
17 Previous Clinical Trials
2,035 Total Patients Enrolled
5 Trials studying Seizures
896 Patients Enrolled for Seizures
Worldwide Clinical TrialsOTHER
61 Previous Clinical Trials
13,507 Total Patients Enrolled
3 Trials studying Seizures
880 Patients Enrolled for Seizures
Medical DirectorStudy DirectorXenon Pharmaceuticals Inc.
2,782 Previous Clinical Trials
8,065,436 Total Patients Enrolled
3 Trials studying Seizures
587 Patients Enrolled for Seizures
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not planning to join another drug study or use an experimental device for my epilepsy or any other condition during this study and for 28 days after.
Research Study Groups:
This trial has the following groups:- Group 1: XEN1101 25 mg/day
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
What health risks can be expected with a 25 mg/day dosage of XEN1101?
"As this is a Phase 3 trial with existing evidence of efficacy and safety, our team at Power have assessed the security of XEN1101 25 mg/day to be an exceptional score of 3."
Answered by AI
Does this experiment have any available slots for volunteers?
"Clinicaltrials.gov indicates that this medical trial, which was initially uploaded on April 25th 2023 and revised 5 days later, is no longer recruiting patients. However, 303 other trials are currently in need of participants."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger