XEN1101 for Epilepsy

(X-TOLE4 Trial)

Recruiting at 96 trial locations

Overseen By Xenon Pharmaceuticals Inc.

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Xenon Pharmaceuticals Inc.

Disqualifiers: Medical condition, Experimental device, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: Up to 3 years

880 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will test the safety and effectiveness of taking a 25 mg pill of XEN1101 in patients with specific types of seizures. The goal is to see if it can help control their seizures by affecting brain activity. Participants must have completed earlier related studies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

Research Team

Medical Director

Principal Investigator

Xenon Pharmaceuticals Inc.

Eligibility Criteria

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.

Inclusion Criteria

Subject must have successfully completed the DBP and have not terminated early from Study X-TOLE2, X-TOLE3, or X-ACKT, met all eligibility requirements, and had no important protocol deviations (in the opinion of the sponsor) or AEs (in the opinion of the investigator) that would preclude the subject's entry into the long-term extension study.

In the opinion of the investigator, the subject is able to understand verbal and written instructions and will adhere to all study schedules and requirements.

Subject is able to keep accurate seizure diaries.

Exclusion Criteria

Subject has any medical condition, personal circumstance, or ongoing AE (from Study X-TOLE2, X-TOLE3, or X-ACKT) that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study, or prevents adherence to the protocol.

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.

Subject met any of the withdrawal criteria while in Study X-TOLE2, X-TOLE3, or X-ACKT.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Not specified

Treatment

Participants receive XEN1101 for the treatment of seizures, with visits at 2-, 4-, and 13-weeks post-entry, and subsequent visits at 13-week intervals during the first year, then at 26-week intervals with a telephone call in between

Up to 3 years

Visits at 2, 4, 13 weeks, then every 13 weeks for the first year, and every 26 weeks thereafter

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Treatment Details

Interventions

• XEN1101

Trial Overview 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.

Participant Groups

Group I: XEN1101 15 or 25 mg/day Experimental Treatment 1 Intervention

XEN1101 15 or 25 mg/day

Who Is Running the Clinical Trial?

Xenon Pharmaceuticals Inc.

Lead Sponsor

Trials

19

Recruited

3,400+

Worldwide Clinical Trials

Collaborator

Trials

70

Recruited

15,800+