Trial · NCT04639310
XEN496 (Ezogabine) in Children With KCNQ2 Developmental and Epileptic Encephalopathy
NCT04639310, Phase 3, Terminated, Xenon Pharmaceuticals Inc.; results first posted 2024-08-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. XEN496 (Ezogabine) in Children With KCNQ2 Developmental and Epileptic Encephalopathy. Trials, record NCT04639310. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04639310
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- XEN496 (Ezogabine) in Children With KCNQ2 Developmental and Epileptic Encephalopathy
- NCT number
- NCT04639310
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 8 participants, actual
- Lead sponsor
- Xenon Pharmaceuticals Inc.
- Conditions
- Epilepsy, Epilepsy in Children, Epilepsy; Seizure, Disease, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Epileptic Syndromes
- Interventions
- XEN496, Placebo
- First posted
- 2020-11-20
- Last updated
- 2024-08-23
- Other registries' IDs
- eudract:2020-002396-35
- Results first posted
- 2024-08-23
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Monthly (28 Day) Countable Motor Seizure Frequency During the Blinded Treatment Period | From baseline to the end of the double-blind, 12 week treatment period (maintenance) | Parent/caregiver seizure diary record will be used to assess frequency, type and duration of seizure activity |
| Secondary | Percentage of Subjects With ≥50 Percent Reduction in Monthly (28 Day) Seizure Frequency | From baseline to the end of the double-blind, 12 week treatment period (maintenance) | Parent/caregiver seizure diary record will be used to assess frequency, type of seizure with a duration of at least 3 seconds. |
| Secondary | Caregiver Global Impression of Change (CaGI-C) Scores for the Subject's Overall Condition and for Seizures | Study Day 109 | CaGI-C scale is a caregiver-reported assessment of the change from baseline in the subject's overall condition and seizure severity. Responses to the CaGI-C questionnaire are to be rated on a 7-point Likert scale anchored at 1="Very much improved" and 7="Very much worse". Subjects at least minimally improved compared to baseline (a score of \<=3) for overall condition or for seizure severity are reported in the analysis population. The primary comparison between treatments will be based on the last visit in the double-blind treatment period (or the early termination visit if the patient discontinued the treatment early). The results at Study Day 109 (end of treatment period) are provided. |
| Secondary | Change From Baseline in the Caregiver Global Impression of Severity (CaGI-S) for the Subject's Overall Condition and for Seizures | Study Day 109 | CaGI-S scale is Caregiver-reported assessment of the severity of the subject's seizures and overall condition over the previous 7 days. Responses to the CaGI-S questionnaire are to be rated on a 5-point Likert scale ranging from none to very severe. The CaGI-S consists of single items relating to each concept and is scored by the caregiver using a 5-point response ranging from 1 to 5, anchored at 1="None" and 5="Very Severe". Subjects with improvement of at least 1 level compared to baseline for overall condition or for seizure severity are reported in the analysis population. The results at Study Day 109 (end of treatment period) are provided. |
| Other | Safety and Tolerability of XEN496 (e.g., Adverse Events) in Pediatric Subjects With KCNQ2-DEE | From screening through study completion (Day 109) or Day 151 for those not entering the OLE | To assess adverse events as criteria for safety and tolerability |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Monthly (28 Day) Countable Motor Seizure Frequency During the Blinded Treatment Period | From baseline to the end of the double-blind, 12 week treatment period (maintenance) | percentage change from baseline | MEAN | |
| SECONDARY | Percentage of Subjects With ≥50 Percent Reduction in Monthly (28 Day) Seizure Frequency | From baseline to the end of the double-blind, 12 week treatment period (maintenance) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Caregiver Global Impression of Change (CaGI-C) Scores for the Subject's Overall Condition and for Seizures | Study Day 109 | Subjects at least minimally improved (a score of \<=3) compared to baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in the Caregiver Global Impression of Severity (CaGI-S) for the Subject's Overall Condition and for Seizures | Study Day 109 | Subjects with improvement of at least 1 level compared to baseline | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Safety and Tolerability of XEN496 (e.g., Adverse Events) in Pediatric Subjects With KCNQ2-DEE | From screening through study completion (Day 109) or Day 151 for those not entering the OLE | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Monthly (28 Day) Countable Motor Seizure Frequency During the Blinded Treatment Period | XEN496 | -46.0 | Standard Deviation 23.49 | percentage change from baseline | |
| Percent Change From Baseline in Monthly (28 Day) Countable Motor Seizure Frequency During the Blinded Treatment Period | Placebo | 25.6 | Standard Deviation 46.84 | percentage change from baseline | |
| Percentage of Subjects With ≥50 Percent Reduction in Monthly (28 Day) Seizure Frequency | XEN496 | 2 | Participants | ||
| Percentage of Subjects With ≥50 Percent Reduction in Monthly (28 Day) Seizure Frequency | Placebo | 0 | Participants | ||
| Caregiver Global Impression of Change (CaGI-C) Scores for the Subject's Overall Condition and for Seizures | XEN496 | Overall Condition | 1 | Participants | |
| Caregiver Global Impression of Change (CaGI-C) Scores for the Subject's Overall Condition and for Seizures | Placebo | Overall Condition | 1 | Participants | |
| Caregiver Global Impression of Change (CaGI-C) Scores for the Subject's Overall Condition and for Seizures | XEN496 | Seizure Severity | 1 | Participants | |
| Caregiver Global Impression of Change (CaGI-C) Scores for the Subject's Overall Condition and for Seizures | Placebo | Seizure Severity | 1 | Participants | |
| Change From Baseline in the Caregiver Global Impression of Severity (CaGI-S) for the Subject's Overall Condition and for Seizures | XEN496 | Overall Condition | 0 | Participants | |
| Change From Baseline in the Caregiver Global Impression of Severity (CaGI-S) for the Subject's Overall Condition and for Seizures | Placebo | Overall Condition | 1 | Participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | XEN496 | 5 | |
| Overall Study | STARTED | Placebo | 3 | |
| Overall Study | COMPLETED | XEN496 | 5 | |
| Overall Study | COMPLETED | Placebo | 2 | |
| Overall Study | NOT COMPLETED | XEN496 | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events52
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COVID-19 | Infections and infestations | XEN496 | 0 | 5 | |
| other | COVID-19 | Infections and infestations | Placebo | 2 | 3 | |
| other | Upper respiratory tract infection | Infections and infestations | XEN496 | 1 | 5 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 1 | 3 | |
| other | Viral infection | Infections and infestations | XEN496 | 2 | 5 | |
| other | Viral infection | Infections and infestations | Placebo | 0 | 3 | |
| other | Bronchitis | Infections and infestations | XEN496 | 0 | 5 | |
| other | Bronchitis | Infections and infestations | Placebo | 1 | 3 | |
| other | Nasopharyngitis | Infections and infestations | XEN496 | 1 | 5 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 0 | 3 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | XEN496 | 0 | 5 |
| Total, all-cause mortality | Placebo | 0 | 3 |
| Total, other adverse events | XEN496 | 5 | 5 |
| Total, other adverse events | Placebo | 3 | 3 |
| Total, serious adverse events | XEN496 | 1 | 5 |
| Total, serious adverse events | Placebo | 1 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| XEN496 vs Placebo: Percentage of Subjects With ≥50 Percent Reduction in Monthly (28 Day) Seizure Frequency | Trial comparisons |
| XEN496 vs Placebo: deaths from any cause | Trial comparisons |
| XEN496 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04639310
GET https://conductscience.org/api/trials/v1/NCT04639310/results?page=2