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A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures

Join a study comparing XEN1101 and placebo for focal seizures.

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18 years and older
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Phase 3

The X-TOLE2 Phase 3 clinical trial is a study to see how well and safely a medicine called XEN1101 works for people with focal-onset seizures. Focal-onset seizures start in one area of the brain. In this study, 360 participants will be randomly split into three groups. Some will get XEN1101, while others will receive a placebo, which is a pill that looks like the real medicine but doesn’t have any medicine in it. The study will last for about 21.5 weeks. First, there will be up to 9.5 weeks to check how often seizures happen, followed by 12 weeks of taking the pills. People who finish this part can join a longer study to keep taking XEN1101 if they want.

  • The study lasts about 21.5 weeks, plus 8 more weeks if you don't join the longer study.
  • Participants need to be on 1 to 3 stable anti-seizure medicines for at least a month before starting.
  • People must have had focal epilepsy for at least 2 years and keep a seizure diary.
Study details
    Focal Onset Seizures

NCT05614063

Xenon Pharmaceuticals Inc.

8 March 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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