Trial · NCT03116828

A Study of a Drug to be Used in Addition With Another Drug to Treat Adults With Uncontrolled Partial-onset Seizures

NCT03116828, Phase 4, Completed, Sumitomo Pharma America, Inc.; results first posted 2020-06-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of a Drug to be Used in Addition With Another Drug to Treat Adults With Uncontrolled Partial-onset Seizures. Trials, record NCT03116828. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03116828

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Trial

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

Title: A Study of a Drug to be Used in Addition With Another Drug to Treat Adults With Uncontrolled Partial-onset Seizures
NCT number: NCT03116828
Status: Completed
Phases: Phase 4
Enrollment: 102 participants, actual
Lead sponsor: Sumitomo Pharma America, Inc.
Conditions: Epilepsy With Partial On-set Seizures
Interventions: Eslicarbazepine acetate, Eslicarbazepine Acetate
First posted: 2017-04-17
Last updated: 2020-06-16
Results first posted: 2020-06-16

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	The Number of Subjects Completing 24 Weeks Adjunctive Therapy During Maintenance Phase	From the date of the first dose of the study drug until the completion of 24 weeks Maintenance Phase	Phase 4 study of eslicarbazepine acetate (ESL) as adjunctive therapy in adult subjects with a diagnosis of epilepsy with Partial-onset seizures (POS). Two groups of ESL-naïve subjects will be evaluated

Source ClinicalTrials.gov

Outcomes1

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Number of Subjects Completing 24 Weeks Adjunctive Therapy During Maintenance Phase	From the date of the first dose of the study drug until the completion of 24 weeks Maintenance Phase		participants	NUMBER

Source ClinicalTrials.gov

Results by group2

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

Outcome	Group	Category	Value	Spread	Units
The Number of Subjects Completing 24 Weeks Adjunctive Therapy During Maintenance Phase	Eslicarbazepine Acetate (Arm 1)		36		participants
The Number of Subjects Completing 24 Weeks Adjunctive Therapy During Maintenance Phase	Eslicarbazepine Acetate (Arm 2)		37		participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm 1	44
Overall Study	STARTED	Arm 2	58
Overall Study	COMPLETED	Arm 1	36
Overall Study	COMPLETED	Arm 2	37
Overall Study	NOT COMPLETED	Arm 1	8
Overall Study	NOT COMPLETED	Arm 2	21

Source ClinicalTrials.gov

Adverse events42

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	Diplopia	Eye disorders	Arm 1	1	44	1
other	Diplopia	Eye disorders	Arm 2	4	58	7
other	Nausea	Gastrointestinal disorders	Arm 1	4	44	4
other	Nausea	Gastrointestinal disorders	Arm 2	11	58	13
other	Vomiting	Gastrointestinal disorders	Arm 1	1	44	1
other	Vomiting	Gastrointestinal disorders	Arm 2	6	58	7
other	Fatigue	General disorders	Arm 1	2	44	2
other	Fatigue	General disorders	Arm 2	9	58	10
other	Oedema peripheral	General disorders	Arm 1	0	44	0
other	Oedema peripheral	General disorders	Arm 2	3	58	3

1 to 10 of 42Source ClinicalTrials.gov

See all 42 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm 1	0	44
Total, all-cause mortality	Arm 2	0	58
Total, other adverse events	Arm 1	21	44
Total, other adverse events	Arm 2	36	58
Total, serious adverse events	Arm 1	0	44
Total, serious adverse events	Arm 2	4	58

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
Eslicarbazepine Acetate (Arm 1) vs Eslicarbazepine Acetate (Arm 2): The Number of Subjects Completing 24 Weeks Adjunctive Therapy During Maintenance Phase	Trial comparisons
Arm 1 vs Arm 2: deaths from any cause	Trial comparisons
Arm 1 vs Arm 2: 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.

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/NCT03116828

GET https://conductscience.org/api/trials/v1/NCT03116828/events?page=2

API reference For AI assistants