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XEN496 for Childhood Epilepsy (EPIK Trial)

Phase 3

Waitlist Available

Research Sponsored by Xenon Pharmaceuticals Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from screening through study completion (day 109) or day 151 for those not entering the ole

Awards & highlights

Pivotal Trial

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trial is testing XEN496 (ezogabine) to see if it can help reduce seizures in young children with a specific genetic condition. The medication works by stabilizing brain activity. Children with this condition often do not respond well to typical treatments. Ezogabine is a recently approved medication that helps stabilize brain activity.

Eligible Conditions

Childhood Epilepsy
Nervous System Disorders
Brain Diseases
Limbic-predominant Age-related TDP-43 Encephalopathy
Permanent Neurological Damage
Epilepsy
Central Nervous System Disorders
Central Nervous System Disease
Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening through study completion (day 109) or day 151 for those not entering the ole

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from screening through study completion (day 109) or day 151 for those not entering the ole

This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening through study completion (day 109) or day 151 for those not entering the ole for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent Change From Baseline in Monthly (28 Day) Countable Motor Seizure Frequency During the Blinded Treatment Period

Secondary study objectives

Caregiver Global Impression of Change (CaGI-C) Scores for the Subject's Overall Condition and for Seizures

Change From Baseline in the Caregiver Global Impression of Severity (CaGI-S) for the Subject's Overall Condition and for Seizures

Percentage of Subjects With ≥50 Percent Reduction in Monthly (28 Day) Seizure Frequency

Other study objectives

Safety and Tolerability of XEN496 (e.g., Adverse Events) in Pediatric Subjects With KCNQ2-DEE

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: XEN496Experimental Treatment1 Intervention

24-day dose titration period to a top dose of 21 mg/kg/day. Subjects continue at the top dose, or the highest tolerated dose up to the top dose, for 12-week maintenance period. If the subject does not immediately enter into the separate open-label extension (OLE) study, the maintenance period will be followed by a 15-day taper period.

Group II: PlaceboPlacebo Group1 Intervention

To maintain the blinded aspect of the study, subjects will be titrated on placebo over the 24-day period and remain at this dose for the 12-week maintenance period. If the subject does not immediately enter into the separate OLE study, the maintenance period will be followed by a 15-day taper period.

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