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

PHASE3RECRUITING

The X-TOLE2 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive therapy in focal-onset seizures.

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Study details:

Approximately 360 subjects will be randomized in a blinded manner to one of two active treatment groups or placebo in a 1:1:1 fashion (XEN1101 25 mg : 15 mg : Placebo). Eligible subjects will have up to 9. 5 weeks of baseline to assess frequency of seizures, followed by 12 weeks of blinded treatment.

In order to be included in the study, subjects must be treated with a stable dose of 1 to 3 allowable antiseizure medications (ASMs) for at least one month prior to screening, during baseline, and throughout the double-blind treatment period (DBP) of the study. During the DBP, subjects will be instructed to orally take XEN1101 or placebo once daily with an evening meal. Subjects who complete the 12-week DBP will have the opportunity to qualify and enroll in a separate open-label extension (OLE) study for continued treatment with XEN1101.

Subjects who do not enroll in the OLE will enter a 8-week post treatment follow-up period.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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

Diagnosis (≥2 years) of focal epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy (2017). Subject must have had adequate trials of at least 2 ASMs, which were given (and tolerated) at adequate therapeutic doses, without achieving sustained seizure freedom.

Treatment with a stable dose of 1 to 3 allowable current ASMs for at least one month prior to screening, during baseline, and throughout the duration of the DBP

Able to keep accurate seizure diaries

Exclusion criteria

Previously documented electroencephalogram which shows any pattern not consistent with focal etiology of seizures.

History of focal aware non-motor seizures only, non-epileptic psychogenic seizure, primary generalized seizure, developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome.

Seizures secondary to drug or alcohol use, ongoing infection, neoplasia, demyelinating disease, degenerative neurological disease, metabolic illness, progressive structural lesion, encephalopathy, or progressive central nervous system (CNS) disease.

History of status epilepticus or repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures cannot be counted.

History of neurosurgery for seizures <1 year prior to Visit 1, or radiosurgery <2 years prior to enrollment.

Any medical condition or personal circumstance that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study or prevents adherence to the protocol.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-11-18

Primary completion: 2025-04-01

Study completion finish: 2025-06-01

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT05614063

Intervention or treatment

DRUG: XEN1101

DRUG: Placebo

Conditions

• Focal Onset Seizures

Condition: Focal Onset Seizures
DRUG: XEN1101 and other drugs
Westmead, New South Wales, Australia and more
Sponsor: Xenon Pharmaceuticals Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Westmead Hospital

Research sites nearby

Select from list below to view details:

Westmead Hospital
Westmead, New South Wales, Australia
St Vincent's Hospital Melbourne
Fitzroy, Melbourne, Australia
Royal Prince Alfred Hospital (RAPH)
Camperdown, New South Wales, Australia
Southern Neurology
Sydney, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: XEN1101 25 mg/day XEN1101 25 mg/day	DRUG: XEN1101 XEN1101 Capsules
EXPERIMENTAL: XEN1101 15 mg/day XEN1101 15 mg/day	DRUG: XEN1101 XEN1101 Capsules
PLACEBO_COMPARATOR: Placebo Placebo	DRUG: Placebo Placebo Capsules

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Median percent change (MPC) in monthly (28 days) focal seizure frequency from baseline to DBP for XEN1101 versus placebo.	Not Specified	From baseline through to the double blind period (week 12)

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Proportion of subjects experiencing ≥50% reduction in monthly (28 days) focal seizure frequency from baseline through the DBP for XEN1101 versus placebo.	Not Specified	From baseline through to the double blind period (week 12)
MPC in weekly (7 days) focal seizure frequency from baseline to Week 1 for XEN1101 versus placebo.	Not Specified	From baseline through to the week 1
Proportion of subjects experiencing "at least much improved" (including "much" and "very much improved") in Patient Global Impression of Change (PGI-C).	Not Specified	From baseline through to the double blind period (week 12)
To assess adverse events as criteria for safety and tolerability of XEN1101	Not Specified	From screening through to 56 days post-final dose.

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Connect to trial

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures