Trial · NCT00957684

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

NCT00957684, Phase 3, Completed, Bial - Portela C S.A.; results first posted 2013-10-10

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 Seizures. Trials, record NCT00957684. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00957684

On this page

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 Seizures
NCT number: NCT00957684
Status: Completed
Phases: Phase 3
Enrollment: 402 participants, actual
Lead sponsor: Bial - Portela C S.A.
Conditions: Refractory Partial Epilepsy
Interventions: eslicarbazepine acetate, placebo
First posted: 2009-08-12
Last updated: 2025-03-12
Results first posted: 2013-10-10

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Part I: Seizure Frequency	12-week maintenance period	The primary efficacy endpoint is the natural log transformation of the seizure frequency per 4 weeks. The primary efficacy analysis was based on the intention-to-treat (ITT) population. Efficacy analyses were performed chiefly using data from the 12-week maintenance period in Part I of the study. The primary efficacy variable is the ln transformation of the seizure frequency per 4 weeks. Seizure frequency was compared between each active treatment group and the placebo group using an ANCOVA that models seizure frequency as a function of baseline seizure frequency and treatment.to a "frequency per 4 weeks" basis

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	Part I: Seizure Frequency	12-week maintenance period	The primary efficacy analysis was based on the ITT population.	ln (Seizures) per 4 weeks	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Spread	Units
Part I: Seizure Frequency	Placebo	7.64	95% Confidence Interval 0.0563	ln (Seizures) per 4 weeks
Part I: Seizure Frequency	ESL 400 mg	6.73	95% Confidence Interval 0.0563	ln (Seizures) per 4 weeks
Part I: Seizure Frequency	ESL 800 mg	5.66	95% Confidence Interval 0.0558	ln (Seizures) per 4 weeks
Part I: Seizure Frequency	ESL 1200 mg	5.35	95% Confidence Interval 4.63 to 6.12	ln (Seizures) per 4 weeks

Source ClinicalTrials.gov

Participant flow50

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

Period	Milestone	Group	Participants
PART I	STARTED	ESL 1200 mg Once Daily	102
PART I	STARTED	ESL 800 mg Once Daily	98
PART I	STARTED	ESL 400 mg Once Daily	100
PART I	STARTED	Placebo	102
PART I	STARTED	ESL - Part II	0
PART I	Randomised (Safety Population)	ESL 1200 mg Once Daily	102
PART I	Randomised (Safety Population)	ESL 800 mg Once Daily	98
PART I	Randomised (Safety Population)	ESL 400 mg Once Daily	100
PART I	Randomised (Safety Population)	Placebo	102
PART I	Randomised (Safety Population)	ESL - Part II	0

1 to 10 of 50Source ClinicalTrials.gov

See all 50 participant flow

Adverse events120

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	ESL 1200 mg Once Daily	14	102	14
other	Dizziness	Nervous system disorders	ESL 400 mg Once Daily	4	100	4
other	Dizziness	Nervous system disorders	ESL 800 mg Once Daily	14	98	14
other	Dizziness	Nervous system disorders	Placebo	2	102	2
other	Headache	Nervous system disorders	ESL 1200 mg Once Daily	11	102	11
other	Headache	Nervous system disorders	ESL 400 mg Once Daily	5	100	5
other	Headache	Nervous system disorders	ESL 800 mg Once Daily	9	98	9
other	Headache	Nervous system disorders	Placebo	6	102	6
other	Somnolence	Nervous system disorders	ESL 1200 mg Once Daily	10	102	10
other	Somnolence	Nervous system disorders	ESL 400 mg Once Daily	6	100	6

1 to 10 of 120Source ClinicalTrials.gov

See all 120 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ESL 1200 mg Once Daily
Total, all-cause mortality	ESL 400 mg Once Daily
Total, all-cause mortality	ESL 800 mg Once Daily
Total, all-cause mortality	Placebo
Total, other adverse events	ESL 1200 mg Once Daily	62	102
Total, other adverse events	ESL 400 mg Once Daily	27	100
Total, other adverse events	ESL 800 mg Once Daily	49	98
Total, other adverse events	Placebo	14	102
Total, serious adverse events	ESL 1200 mg Once Daily	3	102
Total, serious adverse events	ESL 400 mg Once Daily	9	100

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
33338829	DERIVED

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/NCT00957684

GET https://conductscience.org/api/trials/v1/NCT00957684/flow?page=2

API reference For AI assistants