XEN1101 for Seizures

(X-ACKT Trial)

Recruiting at 134 trial locations

Overseen By Xenon Medical Affairs

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Xenon Pharmaceuticals Inc.

Must be taking: Antiseizure medications

Disqualifiers: Focal-onset seizures, Schizophrenia, Bipolar, others

Stay on Your Current Meds You can continue your current medications while participating

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: Unknown

Duration: 12 weeks

160 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stay on a stable dose of your current anti-seizure medications throughout the study.

What is the purpose of this trial?

This trial tests XEN1101, a medication added to current treatments, in people with generalized epilepsy experiencing PGTCS who are already on 1-3 anti-seizure medications. The goal is to see if taking XEN1101 with an evening meal can help reduce seizure frequency.

Research Team

Medical Director

Principal Investigator

Xenon Pharmaceuticals Inc.

Eligibility Criteria

This trial is for adults over 18 with a BMI ≤40 who have generalized epilepsy with tonic-clonic seizures despite trying at least two anti-seizure medications. They must be on a stable dose of their current meds and able to track their seizures. Excluded are those with recent severe seizure episodes, non-epileptic psychogenic seizures, or significant mental health issues.

Inclusion Criteria

Subject is properly informed of the nature and risks of the study and gives informed consent in writing prior to entering the study (for adult subjects) and for adolescent subjects parent/legal guardian and subject gives informed consent or assent in writing prior to entering the study

Subject is able to keep accurate seizure diaries

I have been on 1 to 3 approved seizure medications for at least a month.

Exclusion Criteria

Subject has any clinically significant laboratory abnormalities or clinically significant abnormalities on prestudy physical examination, vital signs, or ECG that, in the judgment of the investigator, indicate a medical problem that would preclude study participation, including but not limited to: a. History or presence of long QT syndrome; QTcF >450 msec at baseline; family history of sudden death of unknown cause

Any personal circumstance that, in the opinion of the investigator, prevents adherence to the protocol

Subject has history of repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures cannot be counted

Timeline

Screening

Participants are screened for eligibility to participate in the trial

9.5 weeks

Treatment

Participants receive 12 weeks of blinded treatment with XEN1101 or placebo

12 weeks

Daily oral administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment with XEN1101 long-term

Treatment Details

Interventions

• XEN1101

Trial Overview The study tests XEN1101 as an additional treatment for epilepsy against a placebo in a double-blind setup, meaning neither the participants nor the researchers know who's getting the real drug versus the placebo during the trial.

Participant Groups

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

XEN1101 25 mg/day

Group II: XEN1101 15 mg/day Experimental Treatment 1 Intervention

XEN1101 15 mg/day

Group III: Placebo Placebo Group 1 Intervention

Placebo

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+