Trial · NCT00957372

Efficacy and Safety of Eslicarbazepine Acetate as Adjunctive Therapy for Refractory Partial Epilepsy

NCT00957372, Phase 3, Completed, Bial - Portela C S.A.; results first posted 2013-08-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Eslicarbazepine Acetate as Adjunctive Therapy for Refractory Partial Epilepsy. Trials, record NCT00957372. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00957372

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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 as Adjunctive Therapy for Refractory Partial Epilepsy
NCT number: NCT00957372
Status: Completed
Phases: Phase 3
Enrollment: 253 participants, actual
Lead sponsor: Bial - Portela C S.A.
Conditions: Partial Epilepsy
Interventions: eslicarbazepine acetate, placebo (Part I), ESL - Open-label Extension (Part II)
First posted: 2009-08-12
Last updated: 2014-07-02
Results first posted: 2013-08-05

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	12 weeks	The primary efficacy endpoint is the natural log transformation of the seizure frequency per 4 weeks. The primary efficacy analysis was based on results for the ITT population during the 12-week maintenance period. Seizure frequency was compared between each active treatment group and the placebo group using an ANCOVA model with treatment as a factor and seizure frequency as a covariate
Primary	PART II: Nº of Treatment-Emergent Adverse Events (TEAE)	1-year	The primary objective for Part II of the study was to evaluate the safety and tolerability of eslicarbazepine acetate (ESL, BIA 2-093) at doses titrated to an efficacy or safety endpoint over a 1-year open-label period. Safety assessments were based primarily on AEs (Number of participants with at least one treatment-emergent adverse events are reported); assessment of AEs was based on treatment relatedness, action taken on study drug, outcome, and causality.

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	12 weeks	The primary efficacy analysis was based on the ITT population.The intent-to-treat (ITT) population included all randomized patients with at least one dose of investigational product and at least one post-baseline seizure frequency assessment	ln (Seizures) per 4 weeks	LEAST_SQUARES_MEAN
PRIMARY	PART II: Nº of Treatment-Emergent Adverse Events (TEAE)	1-year	There was no sample size estimate for Part II. Part II was a 1-year open-label extension for patients who had completed Part I and was willing to continue treatment in Part II.	participants	NUMBER

Source ClinicalTrials.gov

Results by group10

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

Outcome	Group	Value	Spread	Units
Seizure Frequency	Placebo	7.3	95% Confidence Interval 6.3 to 8.5	ln (Seizures) per 4 weeks
Seizure Frequency	ESL 800 mg	5.7	95% Confidence Interval 4.9 to 6.7	ln (Seizures) per 4 weeks
Seizure Frequency	ESL 1200 mg	5.5	95% Confidence Interval 4.6 to 6.5	ln (Seizures) per 4 weeks
PART II: Nº of Treatment-Emergent Adverse Events (TEAE)	TEAE	112		participants
PART II: Nº of Treatment-Emergent Adverse Events (TEAE)	TEAE With Onset Within the First 4 Weeks of Part II	40		participants
PART II: Nº of Treatment-Emergent Adverse Events (TEAE)	TEAE With Onset After the First 4 Weeks of Part II	94		participants
PART II: Nº of Treatment-Emergent Adverse Events (TEAE)	Treatment-related Treatment-emergent Adverse Event	66		participants
PART II: Nº of Treatment-Emergent Adverse Events (TEAE)	TEAE Leading to Discontinuation From the Study	9		participants
PART II: Nº of Treatment-Emergent Adverse Events (TEAE)	Treatment Emergent Serious Adverse Event	11		participants
PART II: Nº of Treatment-Emergent Adverse Events (TEAE)	TEAE Leading to Death	2		participants

Source ClinicalTrials.gov

Participant flow52

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

Period	Milestone	Group	Participants
PART I	STARTED	ESL 1200mg Daily	80
PART I	STARTED	ESL 800mg Daily	85
PART I	STARTED	Placebo	88
PART I	STARTED	Open-label Extension (Part II)	0
PART I	Safety Population	ESL 1200mg Daily	80
PART I	Safety Population	ESL 800mg Daily	85
PART I	Safety Population	Placebo	87
PART I	Safety Population	Open-label Extension (Part II)	0
PART I	Intention-to-Treat Population	ESL 1200mg Daily	77
PART I	Intention-to-Treat Population	ESL 800mg Daily	84

1 to 10 of 52Source ClinicalTrials.gov

See all 52 participant flow

Adverse events64

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	Placebo	9	87	9
other	Dizziness	Nervous system disorders	ESL 800 mg	16	85	16
other	Dizziness	Nervous system disorders	ESL 1200 mg	24	80	24
other	Dizziness	Nervous system disorders	Open-label Extension (Part II)	33	194	33
other	Somnolence	Nervous system disorders	Placebo	8	87	8
other	Somnolence	Nervous system disorders	ESL 800 mg	11	85	11
other	Somnolence	Nervous system disorders	ESL 1200 mg	11	80	11
other	Somnolence	Nervous system disorders	Open-label Extension (Part II)	19	194	19
other	Headache	Nervous system disorders	Placebo	10	87	10
other	Headache	Nervous system disorders	ESL 800 mg	5	85	5

1 to 10 of 64Source ClinicalTrials.gov

See all 64 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	ESL 800 mg
Total, all-cause mortality	ESL 1200 mg
Total, all-cause mortality	Open-label Extension (Part II)
Total, other adverse events	Placebo	31	87
Total, other adverse events	ESL 800 mg	41	85
Total, other adverse events	ESL 1200 mg	57	80
Total, other adverse events	Open-label Extension (Part II)	80	194
Total, serious adverse events	Placebo	0	87
Total, serious adverse events	ESL 800 mg	0	85

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

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 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.

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API reference For AI assistants