Trial · NCT03796962

A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy

NCT03796962, Phase 2, Active not recruiting, Xenon Pharmaceuticals Inc.; results first posted 2024-09-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy. Trials, record NCT03796962. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03796962

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy
NCT number: NCT03796962
Status: Active not recruiting
Phases: Phase 2
Enrollment: 325 participants, actual
Lead sponsor: Xenon Pharmaceuticals Inc.
Conditions: Focal Epilepsy
Interventions: XEN1101
First posted: 2019-01-08
Last updated: 2026-11-05
Other registries' IDs: eudract:2018-003221-29
Results first posted: 2024-09-24

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Median Percent Change in Focal Seizure Frequency	From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56)	Median percent change in monthly (28 days) focal seizure frequency from baseline to DBP for XEN1101 versus placebo
Secondary	50% XEN1101 Response Rate	From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56)	Responders are defined as patients experiencing ≥50% reduction in monthly (28 days) focal seizure frequency from baseline to DBP
Secondary	Percent Change in Focal Seizure Frequency Over Time	From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56)	Percent change from baseline in focal seizure frequency at Month 1 and Month 2 in the DBP

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Median Percent Change in Focal Seizure Frequency	From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56)	mITT	Percent change	MEDIAN
SECONDARY	50% XEN1101 Response Rate	From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56)	mITT Population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percent Change in Focal Seizure Frequency Over Time	From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56)	mITT population	Percent change from baseline	MEDIAN

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Median Percent Change in Focal Seizure Frequency	25 mg XEN1101		-52.8	Inter-Quartile Range -80.4 to -16.9	Percent change
Median Percent Change in Focal Seizure Frequency	20 mg XEN1101		-46.4	Inter-Quartile Range -76.7 to -14.0	Percent change
Median Percent Change in Focal Seizure Frequency	10 mg XEN1101		-33.2	Inter-Quartile Range -61.8 to 0.0	Percent change
Median Percent Change in Focal Seizure Frequency	Placebo		-18.2	Inter-Quartile Range -37.3 to 7.0	Percent change
50% XEN1101 Response Rate	25 mg XEN1101		61		Participants
50% XEN1101 Response Rate	20 mg XEN1101		22		Participants
50% XEN1101 Response Rate	10 mg XEN1101		13		Participants
50% XEN1101 Response Rate	Placebo		17		Participants
Percent Change in Focal Seizure Frequency Over Time	25 mg XEN1101	Month 1 (Day 1 to 28)	-55.3	Inter-Quartile Range -78.3 to -16.1	Percent change from baseline
Percent Change in Focal Seizure Frequency Over Time	20 mg XEN1101	Month 1 (Day 1 to 28)	-40.0	Inter-Quartile Range -70.7 to -1.3	Percent change from baseline

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	25 mg XEN1101	114
Overall Study	STARTED	20 mg XEN1101	51
Overall Study	STARTED	10 mg XEN1101	46
Overall Study	STARTED	Placebo	114
Overall Study	COMPLETED	25 mg XEN1101	88
Overall Study	COMPLETED	20 mg XEN1101	43
Overall Study	COMPLETED	10 mg XEN1101	45
Overall Study	COMPLETED	Placebo	109
Overall Study	NOT COMPLETED	25 mg XEN1101	26
Overall Study	NOT COMPLETED	20 mg XEN1101	8

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events128

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	Dizziness	Nervous system disorders	25 mg XEN1101	36	114	36
other	Dizziness	Nervous system disorders	20 mg XEN1101	13	51	13
other	Dizziness	Nervous system disorders	10 mg XEN1101	3	46	3
other	Dizziness	Nervous system disorders	Placebo	8	114	8
other	Somnolence	Nervous system disorders	25 mg XEN1101	17	114	17
other	Somnolence	Nervous system disorders	20 mg XEN1101	11	51	11
other	Somnolence	Nervous system disorders	10 mg XEN1101	5	46	5
other	Somnolence	Nervous system disorders	Placebo	8	114	8
other	Headache	Nervous system disorders	25 mg XEN1101	9	114	9
other	Headache	Nervous system disorders	20 mg XEN1101	6	51	6

1 to 10 of 128Source ClinicalTrials.gov

See all 128 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	25 mg XEN1101	0	114
Total, all-cause mortality	20 mg XEN1101	0	51
Total, all-cause mortality	10 mg XEN1101	0	46
Total, all-cause mortality	Placebo	0	114
Total, other adverse events	25 mg XEN1101	97	114
Total, other adverse events	20 mg XEN1101	35	51
Total, other adverse events	10 mg XEN1101	31	46
Total, other adverse events	Placebo	56	114
Total, serious adverse events	25 mg XEN1101	3	114
Total, serious adverse events	20 mg XEN1101	2	51

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37812429	RESULT

Source PubMed

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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT03796962

GET https://conductscience.org/api/trials/v1/NCT03796962/events?page=2

API reference For AI assistants