XEN1101 for Epilepsy

(X-TOLE Trial)

Recruiting at 109 trial locations

Overseen By NCGS, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Xenon Pharmaceuticals Inc.

Must be taking: AEDs

Must not be taking: Vigabatrin, Felbamate

Disqualifiers: Schizophrenia, Psychotic disorders, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

325 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests XEN1101, a new medication, in adults with focal epilepsy who still have seizures despite taking other anti-epileptic drugs. The goal is to see if XEN1101 can better control their seizures by working with their current medications.

Will I have to stop taking my current medications?

No, you won't have to stop taking your current medications. The trial requires that you continue taking a stable dose of 1 to 3 allowable anti-epileptic drugs (AEDs) throughout the study.

Research Team

Study Director

Principal Investigator

Xenon Pharmaceuticals Inc.

Eligibility Criteria

Adults with a diagnosis of focal epilepsy for at least 2 years, BMI ≤40 kg/m2, on stable doses of 1-3 approved AEDs can join. They must have had prior neuroimaging and be able to keep seizure diaries. Exclusions include history of certain non-focal seizures, recent neurosurgery, psychotic disorders or suicide risk, significant medical conditions like long QT syndrome or cancer within the past two years.

Inclusion Criteria

I agree not to donate sperm/ova during the study and for 6 months after.

Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study

I have been on 1 to 3 epilepsy drugs at a stable dose for at least a month.

Exclusion Criteria

I have had severe allergic reactions to epilepsy drugs.

My seizures are caused by another health condition.

I had neurosurgery for seizures less than a year ago, or radiosurgery less than two years ago.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants' seizure frequency is assessed over an 8-week period

8 weeks

Treatment

Participants receive XEN1101 or placebo once daily in the evening for 8 weeks

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Open-label extension (optional)

Eligible participants receive a 20 mg daily dose of XEN1101

Treatment Details

Interventions

• XEN1101

Trial Overview The trial is testing XEN1101 as an additional treatment for focal epilepsy in adults. It's a randomized study where patients either get XEN1101 or a placebo without knowing which one they're getting. After that phase, there's an optional part where everyone gets XEN1101.

Participant Groups

Group I: 25 mg XEN1101 Experimental Treatment 1 Intervention

Capsule filled with 25 mg XEN1101

Group II: 20 mg XEN1101 Experimental Treatment 1 Intervention

Capsule filled with 20 mg XEN1101

Group III: 10 mg XEN1101 Experimental Treatment 1 Intervention

Capsule filled with 10 mg XEN1101

Group IV: Placebo Placebo Group 1 Intervention

Placebo capsule

Who Is Running the Clinical Trial?

Xenon Pharmaceuticals Inc.

Lead Sponsor

Trials

19

Recruited

3,400+

NCGS, Inc.

Industry Sponsor

Trials

2

Recruited

620+

Novotech Health Holdings Pte. Ltd.

Industry Sponsor

Trials

1

Recruited

330+

Novotech Health Holdings Pte. Ltd.

Collaborator

Trials

1

Recruited

330+