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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%
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%
Hyperglycemia
1%
Intervertebral disc degeneration
1%
Device malfunction
1%
Hyponatremia
1%
Pregnancy
1%
Aphasia
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.
1,208 Previous Clinical Trials
489,687 Total Patients Enrolled

Frequently Asked Questions

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

Are people who are sick currently being enrolled in this drug trial?

"The study, which can be found on clinicaltrials.gov, is seeking more participants. The trial was posted on 3/29/2021 and has been updated as recently as 11/3/2022."

Answered by AI

What do we know about XEN496 from other research?

"At the moment, there are two ongoing studies involving XEN496. Two of those studies are in Phase 3. While most of the trials for XEN496 are taking place in Madrid and Queensland, there are 30 different locations running trials for this treatment."

Answered by AI

Are there any harmful side effects to taking XEN496?

"XEN496's safety is based on evidence from Phase 3 clinical trials as well as other data supporting its efficacy. This makes it a level 3 on our safety scale."

Answered by AI

For individuals that are below the age of 80, are they able to partake in this test?

"The age group being recruited for this clinical trial are children that are 1 month to 6 years old."

Answered by AI

At how many distinct locations is this trial being carried out?

"To participate in this trial, it would be ideal to choose a location closest to you from the 11 available sites. Some of these sites include Philadelphia, Orange, and San Francisco. By lessening the travel required, it makes participating in the trial more logistically feasible."

Answered by AI

To the best of your knowledge, does anything like this exist?

"Since 2021, XEN496 has been the focus of medical research. The first clinical trial, which was sponsored by Xenon Pharmaceuticals Inc., took place in 2021. After the successful initial trial with 40 participants, XEN496 received Phase 3 drug approval. There are currently 2 live studies for XEN496 being conducted across 15 cities and 5 countries."

Answered by AI

For whom does this study qualify?

"Up to 40 patients that are 1 Month to 6 years old and have disease are eligible for this study. Eligibility requirements include the following: a recent MRI with no evidence of abnormalities, taking 1-4 antiseizure medications (VNS and ketogenic diet excluded), meeting additional inclusion criteria (assessed by study team), being male or female, having a documented genetic test consistent with KCNQ2-DEE, and a documented clinical history and EEG consistent with KCNQ2-DEE. Furthermore, applicants must have had focal tonic or other countable motor seizures in the past month."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
XEN496 (Ezogabine) in Children With KCNQ2 Developmental and Epileptic Encephalopathy
2021. "XEN496 (Ezogabine) in Children With KCNQ2 Developmental and Epileptic Encephalopathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04639310.
~2 spots leftby Apr 2025
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