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XEN1101 for Epilepsy (X-TOLE Trial)
X-TOLE Trial Summary
This trial will test if XEN1101 is an effective and safe treatment for focal epilepsy in adults. The trial will be double-blind, meaning neither the patients nor the researchers will know who is receiving the real treatment or the placebo. There will also be an optional open-label extension, meaning that at the end of the trial, patients who wish to can receive the real treatment.
X-TOLE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.X-TOLE Trial Design
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- I agree not to donate sperm/ova during the study and for 6 months after.I have been on 1 to 3 epilepsy drugs at a stable dose for at least a month.You can keep track of your seizures in a detailed diary.I have had severe allergic reactions to epilepsy drugs.I have been diagnosed with focal epilepsy for 2 or more years.My seizures are caused by another health condition.I have been on 1 to 3 epilepsy drugs at a stable dose for at least a month.I agree not to donate sperm/ova during the study and for 6 months after.I had neurosurgery for seizures less than a year ago, or radiosurgery less than two years ago.I don't have any major health issues or another cancer diagnosis in the last 2 years, except for treated skin cancer.I have a history of seizures that are not caused by a physical condition.I have used vigabatrin but my vision tests were not stable after stopping it.I have been diagnosed with focal epilepsy for 2 or more years.I have a heart condition that affects my heartbeat's timing.I have been on felbamate for 2 years with a stable dose for the last 2 months and have normal blood and liver tests.I have had skin or eye issues due to ezogabine.I have or had Lennox-Gastaut syndrome.I do not have schizophrenia, other psychotic disorders, recent suicidal thoughts or attempts.
- Group 1: 10 mg XEN1101
- Group 2: 25 mg XEN1101
- Group 3: 20 mg XEN1101
- Group 4: Placebo
- 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
Do you have an age limit for participants in this clinical trial?
"The age range for patients that are being enrolled in this study is between 18 to 75 years old."
Has XEN1101 completed the necessary steps for FDA approval?
"Given that XEN1101 is still in Phase 2 clinical trials, there is not yet enough data to support its efficacy. However, the available evidence does suggest that it is a safe medication."
How can I sign up to be a part of this research?
"This trial will have 300 participants that suffer from gelastic epilepsy and are between 18-75 years old. The most crucial requirements for potential patients include: a BMI lower or equal to 40 kg/m2, being on a stable dose of 1-3 current AEDs for at least one month prior to screening and throughout the duration of the study, being willing to comply with contraception requirements, and having the ability to keep accurate seizure diaries."
How many facilities are participating in this research project?
"The trial is based in The University of Texas Health Science Center at San Antonio (San Antonio, TX), Northwestern Medical Group, Department of Neurology(Chicago, IL) and the University of Kansas Medical Center (Kansas City, KS). There are also 67 other locations where this study is taking place."
Are we currently enrolling individuals for this research project?
"The most recent information available on clinicaltrials.gov suggests that this particular trial is not actively recruiting patients at the moment. It was initially posted on January 30th, 2019 but has not seen any updates since August 18th, 2020. There are 249 other studies currently looking for participants if you are interested in taking part in medical research."
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