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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 study days 1, 24, 67, 88 and 109
Awards & highlights

EPIK Trial Summary

This trial is testing if XEN496 can help reduce seizures in children with KCNQ2-DEE.

Eligible Conditions
  • Childhood Epilepsy
  • Nervous System Disorders
  • Central Nervous System Disorders
  • Disease
  • Epilepsy
  • Brain Diseases

EPIK Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study days 1, 24, 67, 88 and 109
This trial's timeline: 3 weeks for screening, Varies for treatment, and study days 1, 24, 67, 88 and 109 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Therapeutic procedure
Secondary outcome measures
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
Proportion of subjects with ≥50 percent reduction in monthly (28 day) seizure frequency
Other outcome measures
Assess the safety and tolerability of XEN496 (e.g., adverse events) in pediatric subjects with KCNQ2-DEE

Side effects data

From 2008 Phase 3 trial • 306 Patients • NCT00232596
41%
Dizziness
31%
Somnolence
16%
Fatigue
13%
Confusional state
12%
Urinary tract infection
12%
Headache
12%
Dysarthria
12%
Vision blurred
11%
Ataxia
11%
Tremor
10%
Nausea
8%
Speech disorder
8%
Influenza
8%
Memory impairment
7%
Diplopia
7%
Gait disturbance
6%
Vertigo
6%
Balance disorder
6%
Constipation
6%
Urinary hesitation
5%
Disturbance in attention
5%
Vomiting
5%
Anxiety
5%
Dysuria
5%
Disorientation
4%
Convulsion
4%
Diarrhoea
3%
Abdominal pain
2%
Psychotic disorder
1%
Transaminases increased
1%
Intervertebral disc degeneration
1%
Device malfunction
1%
Pregnancy
1%
Hyperglycemia
1%
Aphasia
1%
Hyponatremia
1%
Status epilepticus
1%
Diarrhea
1%
Encephalopathy
1%
Syncope
1%
Venous Thrombosis
1%
Non-cardiac chest pain
1%
Suicidal ideation
1%
Depression
1%
Dehydration
1%
Diabetic ketoacidosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Retigabine - DB Phase (Titration and Maintenance)
Retigabine (DB Phase) and Retigabine (Transition Phase)
Placebo - Double-blind (DB) Phase (Titration and Maintenance)
Placebo (DB Phase) and Retigabine (Transition Phase)

EPIK 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.

Find a Location

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.
1,221 Previous Clinical Trials
499,966 Total Patients Enrolled
~2 spots leftby Jun 2025
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