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Potassium Channel Opener

XEN496 for Childhood Epilepsy (EPIK-OLE 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 every three months from screening/baseline through to study completion, up to 162 weeks

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Pivotal Trial

Summary

This trial is testing XEN496, a medication for children with a rare form of epilepsy called KCNQ2-DEE. The goal is to see if it can safely help control their seizures by stabilizing brain activity. KCNQ channel openers merit further study as potential treatments for seizures in infants and children.

Eligible Conditions

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every three months from screening/baseline through to study completion, up to 162 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every three months from screening/baseline through to study completion, up to 162 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and every three months from screening/baseline through to study completion, up to 162 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) related to intervention

Secondary study objectives

Change from pre-randomization baseline in the previous study over time based on response categories (<25%, 25 to <50%, 50 to <75%, 75 to <100%, 100%), based on estimated seizure frequency every 3 months during the OLE period

Change in Pediatric Quality of Life Inventory, Family Impact scale in subjects with KCNQ2-DEE

Change in monthly countable motor seizure frequency

+11 more

Awards & Highlights

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.

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Stage 2: Open-Label TreatmentExperimental Treatment1 Intervention

Optimally-tolerated dose level established during the transition/titration period will be maintained throughout the duration of open-label period unless dose adjustment is required. Subjects who discontinue or complete the study treatment will be required to taper off study drug over a period of up to 15 days.

Group II: Stage 1: Blinded Dose Transition/TitrationExperimental Treatment2 Interventions

24-day blinded transition/titration period. Subjects who received XEN496 in the preceding study will continue to receive XEN496 at the same dose, in a blinded manner, without any further titration. Subjects, who were allocated to placebo in the preceding study, will be titrated to a tolerated dose up to a maximum dose of 21 mg/kg/day, with a maximum daily dose of 672 mg/day. To maintain the blinded aspect of the study, placebo will be dispensed to all subjects during the transition/titration period to ensure the total number of capsules are consistent across all subjects. Subjects who discontinue will be required to taper off study drug over a period of up to 15 days

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

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