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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
- Epilepsy
- Nervous System Disorders
- Disease
- Brain Diseases
- Limbic-predominant Age-related TDP-43 Encephalopathy
- Permanent Neurological Damage
- Central Nervous System Disorders
- Central Nervous System Disorder
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
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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Who is running the clinical trial?
Xenon Pharmaceuticals Inc.Lead Sponsor
17 Previous Clinical Trials
2,907 Total Patients Enrolled
Study DirectorStudy DirectorXenon Pharmaceuticals Inc.
1,278 Previous Clinical Trials
499,646 Total Patients Enrolled
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