Trial · NCT00988429

Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Adjunctive Therapy for Refractory Partial Seizures

NCT00988429, Phase 3, Completed, Bial - Portela C S.A.; results first posted 2014-04-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Adjunctive Therapy for Refractory Partial Seizures. Trials, record NCT00988429. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00988429

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Trial

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

Title: Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Adjunctive Therapy for Refractory Partial Seizures
NCT number: NCT00988429
Status: Completed
Phases: Phase 3
Enrollment: 653 participants, actual
Lead sponsor: Bial - Portela C S.A.
Conditions: Partial Epilepsy
Interventions: 800 mg QD Eslicarbazepine acetate, 1200 mg QD Eslicarbazepine acetate, Placebo
First posted: 2009-10-02
Last updated: 2021-05-19
Other registries' IDs: eudract:2008-002455-25
Results first posted: 2014-04-15

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Seizure Frequency Over the 12-week Maintenance Period.	12-week maintenance period (Week 3 to week 14)
Secondary	Proportion of Responders	Baseline (Week-8 through Week -1) and Maintenance period (Week 3 to week 14)	Subjects who had at least a 50% reduction from baseline in standardized seizure frequency during the maintenance period were classified as responders.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Seizure Frequency Over the 12-week Maintenance Period.	12-week maintenance period (Week 3 to week 14)	Intent-to-treat (ITT) population was the primary population for the analysis of efficacy; ITT included all randomized subjects who received at least one dose of study treatment after randomization and had at least one post-baseline seizure frequency assessment.	Nº Standardized Seizures by 4 weeks	LEAST_SQUARES_MEAN
SECONDARY	Proportion of Responders	Baseline (Week-8 through Week -1) and Maintenance period (Week 3 to week 14)	Intent-to-treat (ITT) population was the primary population for the analysis of efficacy; ITT included all randomized subjects who received at least one dose of study treatment after randomization and had at least one post-baseline seizure frequency assessment.	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Value	Spread	Units
Seizure Frequency Over the 12-week Maintenance Period.	Placebo (ITT Population)	7.88	Standard Error 0.49	Nº Standardized Seizures by 4 weeks
Seizure Frequency Over the 12-week Maintenance Period.	ESL 800 mg QD (ITT Population)	6.54	Standard Error 0.41	Nº Standardized Seizures by 4 weeks
Seizure Frequency Over the 12-week Maintenance Period.	ESL 1200 mg QD (ITT Population)	6.00	Standard Error 0.40	Nº Standardized Seizures by 4 weeks
Proportion of Responders	Placebo	23.1	95% Confidence Interval 17.6 to 29.4	percentage of participants
Proportion of Responders	ESL 800 mg QD (ITT Population)	30.5	95% Confidence Interval 24.2 to 37.4	percentage of participants
Proportion of Responders	ESL 1200 mg QD (ITT Population)	42.6	95% Confidence Interval 35.4 to 50.1	percentage of participants

Source ClinicalTrials.gov

Participant flow15

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	226
Overall Study	STARTED	800 mg QD	216
Overall Study	STARTED	1200 mg QD	211
Overall Study	Safety Population	Placebo	224
Overall Study	Safety Population	800 mg QD	216
Overall Study	Safety Population	1200 mg QD	210
Overall Study	Intention-to-treat (ITT) Population	Placebo	220
Overall Study	Intention-to-treat (ITT) Population	800 mg QD	215
Overall Study	Intention-to-treat (ITT) Population	1200 mg QD	205
Overall Study	COMPLETED	Placebo	189

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events306

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
other	Dizziness	Nervous system disorders	Placebo (Safety Population)	19	224
other	Dizziness	Nervous system disorders	ESL 800 mg QD (Safety Population)	34	216
other	Dizziness	Nervous system disorders	ESL 1200 mg QD (Safety Population)	55	210
other	Somnolence	Nervous system disorders	Placebo (Safety Population)	12	224
other	Somnolence	Nervous system disorders	ESL 800 mg QD (Safety Population)	16	216
other	Somnolence	Nervous system disorders	ESL 1200 mg QD (Safety Population)	36	210
other	Nausea	Gastrointestinal disorders	Placebo (Safety Population)	11	224
other	Nausea	Gastrointestinal disorders	ESL 800 mg QD (Safety Population)	16	216
other	Nausea	Gastrointestinal disorders	ESL 1200 mg QD (Safety Population)	32	210
other	Headache	Nervous system disorders	Placebo (Safety Population)	17	224

1 to 10 of 306Source ClinicalTrials.gov

See all 306 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo (Safety Population)
Total, all-cause mortality	ESL 800 mg QD (Safety Population)
Total, all-cause mortality	ESL 1200 mg QD (Safety Population)
Total, other adverse events	Placebo (Safety Population)	125	224
Total, other adverse events	ESL 800 mg QD (Safety Population)	145	216
Total, other adverse events	ESL 1200 mg QD (Safety Population)	163	210
Total, serious adverse events	Placebo (Safety Population)	7	224
Total, serious adverse events	ESL 800 mg QD (Safety Population)	14	216
Total, serious adverse events	ESL 1200 mg QD (Safety Population)	3	210

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32801102	DERIVED	PubMed
33338829	DERIVED	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/NCT00988429

GET https://conductscience.org/api/trials/v1/NCT00988429/events?page=2

API reference For AI assistants