An Open-label Study of XEN1101 in Epilepsy
This study, called X-TOLE4, is designed for people with focal epilepsy or primary generalized tonic-clonic seizures who have already taken part in a previous XEN1101 study. It's an "open-label" study, meaning everyone knows they are receiving the study medicine. The main goals are to check how safe XEN1101 is over a long period (up to six years), how well people tolerate it, and if it helps reduce seizures. Participants will take XEN1101 once a day and keep track of their seizures. Regular visits and phone calls will happen to monitor their progress. This study helps doctors understand the long-term effects of XEN1101.
At a glance
What is this study about?
This study is a long-term research project looking at a medicine called XEN1101 for people who have certain types of epilepsy, specifically focal onset seizures or primary generalized tonic-clonic seizures. These are two common types of seizures. The study will check how safe the medicine is, how well people tolerate it (meaning if they have side effects), and if it helps reduce their seizures over an extended period, up to six years.
This study is a continuation for people who have already taken part in one of three earlier XEN1101 studies (X-TOLE2, X-TOLE3, or X-ACKT). Because it's an "open-label" study, everyone involved will know they are receiving the active medicine, XEN1101. This is different from some studies where participants might receive a placebo (a dummy pill) or another treatment without knowing it.
The overall aim is to gather important information about XEN1101's long-term effects, which is crucial for understanding how helpful and safe it can be as a treatment option for epilepsy.
Key takeaways
- This study assesses XEN1101's long-term safety and effectiveness for epilepsy.
- It's for people familiar with XEN1101 from previous studies.
- Participation involves taking daily medication and keeping a seizure diary.
- Regular check-ups will monitor your health and seizure control.
- The study can last up to six years, providing long-term data.
Who may be eligible?
To join this study, you must have completed one of the previous XEN1101 studies (X-TOLE2, X-TOLE3, or X-ACKT) and not have left that study early. You should also not have had any major issues during the previous study that would make it unsafe for you to continue.
It's important that you or your parent/guardian (if you're an adolescent) understand what the study involves and agree to take part in writing. You also need to be able to follow instructions and keep a regular record of your seizures. Your doctor will make sure that taking part in this study is safe for you and won't put you at unacceptable risk, especially if you have other health conditions or ongoing side effects from the previous study.
You cannot join if you stopped a previous XEN1101 study because of specific withdrawal reasons, or if you plan to take part in another study with a different experimental medicine or device for epilepsy or any other condition during this study and for 28 days afterwards.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Did I complete one of the previous XEN1101 studies (X-TOLE2, X-TOLE3, or X-ACKT)?
- Am I at least 12 years old?
- Do I understand what the study involves and agree to take part?
- Am I able to keep an accurate daily record of my seizures?
- Am I not planning to join another experimental drug or device study for epilepsy soon?
What does participation involve?
If you join this study, you will be taking XEN1101 once a day, usually with your evening meal. The starting dose will depend on your age and, for some younger participants, your weight. Over the course of the study, which can last up to six years, you will have several appointments. Initially, these will be at 2 weeks, 4 weeks, and 13 weeks. After that, you'll have visits every 13 weeks for the first year, and then every 26 weeks (about every six months) with a phone call in between visits until your treatment period ends.
One important part of participating is keeping a daily electronic diary to record your seizures. You'll need to do this for at least 80% of the days between your appointments. After you finish taking the study medicine, there will be an 8-week follow-up period to check on your health.
This study is open to both males and females, aged 12 years and older.
Potential risks and benefits
Locations (149)
- XenoscienceVerified postcodePhoenix, United States
- University of Arizona - Health SciencesVerified postcodeTucson, United States
- Clinical Trials, IncVerified postcodeLittle Rock, United States
- Brain Science Research InstituteVerified postcodeLos Angeles, United States
- UC Irvine HealthVerified postcodeOrange, United States
- University of California, Davis Clinical & Translational Science Center Clinical Research (CCRC)Verified postcodeSacramento, United States
- University of Colorado Hospital Anschutz Outpatient PavilionVerified postcodeAurora, United States
- Mayo Clinic FloridaVerified postcodeJacksonville, United States
- Serenity Research Center, LLCVerified postcodeMiami, United States
- Research Institute of Orlando, LLCVerified postcodeOrlando, United States
- Panhandle Research & Medical ClinicVerified postcodePensacola, United States
- University of South FloridaVerified postcodeTampa, United States
Common questions
What is the main purpose of this study?
The main purpose is to see how safe XEN1101 is and how well it works over a long time (up to six years) for people with focal epilepsy or tonic-clonic seizures who have already been in a previous XEN1101 study.
Who can join this study?
You can join if you successfully finished one of the previous XEN1101 studies (X-TOLE2, X-TOLE3, or X-ACKT) and meet other health requirements. You must be at least 12 years old.
What will I need to do if I join?
You will take XEN1101 once a day, keep a daily electronic diary of your seizures, and attend regular study visits or phone calls over several years.
Will I know if I'm getting the active medicine?
Yes, this is an "open-label" study, which means everyone involved knows they are receiving the study medicine, XEN1101.
How long will the study last for me?
You could be in the study for up to six years, followed by an 8-week check-up period after you stop taking the medicine.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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