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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

EPIK-OLE Trial Summary

This trial is to assess the long-term safety and tolerability of XEN496 in pediatric subjects with KCNQ2 developmental and epileptic encephalopathy (KCNQ2-DEE) who had participated in the primary study.

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

EPIK-OLE Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) related to intervention
Secondary outcome measures
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

Side effects data

From 2008 Phase 3 trial • 306 Patients • NCT00232596
41%
Dizziness
31%
Somnolence
16%
Fatigue
13%
Confusional state
12%
Headache
12%
Urinary tract infection
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%
Balance disorder
6%
Vertigo
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%
Hyponatremia
1%
Pregnancy
1%
Aphasia
1%
Status epilepticus
1%
Hyperglycemia
1%
Device malfunction
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-OLE 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

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.
1,207 Previous Clinical Trials
489,672 Total Patients Enrolled

Media Library

XEN496 (Potassium Channel Opener) Clinical Trial Eligibility Overview. Trial Name: NCT04912856 — Phase 3
Childhood Epilepsy Research Study Groups: Stage 1: Blinded Dose Transition/Titration, Stage 2: Open-Label Treatment
Childhood Epilepsy Clinical Trial 2023: XEN496 Highlights & Side Effects. Trial Name: NCT04912856 — Phase 3
XEN496 (Potassium Channel Opener) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04912856 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many locations are testing this medication?

"This study is looking for patients from 8 different locations, which include Cleveland, Chicago, and San Francisco among others. To reduce inconvenience, please choose the location nearest you."

Answered by AI

Are octogenarians allowed to participate in this experiment?

"Children that hope to be included in this medical study must be under 6 years old and have reached their first month of life."

Answered by AI

Are there any other ongoing XEN496 research projects?

"There are currently two different clinical trials underway for XEN496. Out of those two, one is in Phase 3. Most of the research surrounding XEN496 is happening in Madrid and Queensland, although there are a total of 30 active trial locations."

Answered by AI

Who else is applying?

How old are they?
< 18
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
An Open-Label Extension of the Study XEN496 (Ezogabine) in Children With KCNQ2-DEE
2021. "An Open-Label Extension of the Study XEN496 (Ezogabine) in Children With KCNQ2-DEE". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04912856.
~2 spots leftby Apr 2025
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