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A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)

ConditionFocal Onset Seizures
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorXenon Pharmaceuticals Inc.

About this trial

The X-TOLE3 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • XEN1101

    Drug

    XEN1101 Capsules

  • Placebo

    Drug

    Placebo Capsules

Treatment groups

360 Participants
are divided into 3 treatment groups
Group A: XEN1101 25 mg/dayExperimental treatment 1 intervention
Group B: XEN1101 15 mg/dayExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Median percent change (MPC) in focal seizure frequency from baseline to DBP for XEN1101 versus placebo.

Time frame
From baseline through to the double blind period (week 12).

Secondary outcomes

1

Proportion of subjects experiencing ≥50% reduction in focal seizure frequency from baseline through the DBP for XEN1101 versus placebo.

Time frame
From baseline through to the double blind period (week 12).
2

MPC in weekly (7 days) focal seizure frequency from baseline to Week 1 for XEN1101 versus placebo.

Time frame
From baseline through to the week 1.
3

Proportion of subjects experiencing "at least much improved" (including "much" and "very much improved") in Patient Global Impression of Change (PGI-C).

Time frame
From baseline through to the double blind period (week 12).
4

To assess adverse events as criteria for safety and tolerability of XEN1101.

Time frame
From screening through to 56 days post-final dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xenon Pharmaceuticals Inc.

Lead sponsor

Worldwide Clinical Trials

Collaborator

Source ClinicalTrials.gov
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