Trial · NCT00957047

Efficacy and Safety Study of BIA 2-093 in Combination With Other Anti-Epileptic Drugs to Treat Partial Epilepsy

NCT00957047, 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 Study of BIA 2-093 in Combination With Other Anti-Epileptic Drugs to Treat Partial Epilepsy. Trials, record NCT00957047. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00957047

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Trial

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

Title: Efficacy and Safety Study of BIA 2-093 in Combination With Other Anti-Epileptic Drugs to Treat Partial Epilepsy
NCT number: NCT00957047
Status: Completed
Phases: Phase 3
Enrollment: 395 participants, actual
Lead sponsor: Bial - Portela C S.A.
Conditions: Partial Epilepsy
Interventions: eslicarbazepine acetate, placebo, ESL - Part II
First posted: 2009-08-12
Last updated: 2025-03-25
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	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 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.
Primary	PART II - Nº of Treatment-Emergent Adverse Events (TEAE)	1 year	Safety assessments were based primarily on AEs (Number of patients who experienced at least one AEs), and on whether these were related to the study medication, were serious, led to permanent discontinuation of study participation, or led to death.

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	PART I - Seizure Frequency	12-week maintenance period	The primary efficacy analysis was an ANCOVA that assessed reduction in seizure frequency per 4 weeks for the ITT population during the 12-week maintenance period	ln (Seizures) per 4 weeks	LEAST_SQUARES_MEAN
PRIMARY	PART II - Nº of Treatment-Emergent Adverse Events (TEAE)	1 year		participants	NUMBER

Source ClinicalTrials.gov

Results by group11

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

Outcome	Group	Value	Spread	Units
PART I - Seizure Frequency	ESL 1200 mg Once Daily	7	95% Confidence Interval 6.0 to 8.1	ln (Seizures) per 4 weeks
PART I - Seizure Frequency	ESL 400 mg Once Daily	8.7	95% Confidence Interval 7.7 to 9.9	ln (Seizures) per 4 weeks
PART I - Seizure Frequency	ESL 800 mg Once Daily	7.1	95% Confidence Interval 6.2 to 8.2	ln (Seizures) per 4 weeks
PART I - Seizure Frequency	Placebo	9.8	95% Confidence Interval 8.7 to 11.1	ln (Seizures) per 4 weeks
PART II - Nº of Treatment-Emergent Adverse Events (TEAE)	TEAE	270		participants
PART II - Nº of Treatment-Emergent Adverse Events (TEAE)	TEAE With Onset Within the 1st 4 Weeks	151		participants
PART II - Nº of Treatment-Emergent Adverse Events (TEAE)	TEAE With Onset After 1st 4 Weeks	240		participants
PART II - Nº of Treatment-Emergent Adverse Events (TEAE)	Treatment-related TEAE	194		participants
PART II - Nº of Treatment-Emergent Adverse Events (TEAE)	TEAE Leading to Discontinuation	37		participants
PART II - Nº of Treatment-Emergent Adverse Events (TEAE)	Serious TEAE	28		participants

1 to 10 of 11Source ClinicalTrials.gov

See all 11 results by group

Participant flow50

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

Period	Milestone	Group	Participants
PART I	STARTED	Placebo	100
PART I	STARTED	ESL 400 mg Once Daily	96
PART I	STARTED	ESL 800 mg Once Daily	101
PART I	STARTED	ESL 1200 mg Once Daily	98
PART I	STARTED	ESL - Part II	0
PART I	Randomized/Safety Population	Placebo	100
PART I	Randomized/Safety Population	ESL 400 mg Once Daily	96
PART I	Randomized/Safety Population	ESL 800 mg Once Daily	101
PART I	Randomized/Safety Population	ESL 1200 mg Once Daily	98
PART I	Randomized/Safety Population	ESL - Part II	0

1 to 10 of 50Source ClinicalTrials.gov

See all 50 participant flow

Adverse events290

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	Coordination abnormal	Nervous system disorders	Placebo	5	100	5
other	Coordination abnormal	Nervous system disorders	ESL 400 mg	5	96	5
other	Coordination abnormal	Nervous system disorders	ESL 800 mg	13	101	13
other	Coordination abnormal	Nervous system disorders	ESL 1200 mg	11	98	11
other	Coordination abnormal	Nervous system disorders	ESL PART II	28	325
other	Diplopia	Eye disorders	Placebo	4	100	4
other	Diplopia	Eye disorders	ESL 400 mg	8	96	8
other	Diplopia	Eye disorders	ESL 800 mg	15	101	15
other	Diplopia	Eye disorders	ESL 1200 mg	10	98	10
other	Diplopia	Eye disorders	ESL PART II	28	325

1 to 10 of 290Source ClinicalTrials.gov

See all 290 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	ESL 400 mg
Total, all-cause mortality	ESL 800 mg
Total, all-cause mortality	ESL 1200 mg
Total, all-cause mortality	ESL PART II
Total, other adverse events	Placebo	59	100
Total, other adverse events	ESL 400 mg	75	96
Total, other adverse events	ESL 800 mg	84	101
Total, other adverse events	ESL 1200 mg	78	98
Total, other adverse events	ESL PART II	270	325

1 to 10 of 15Source ClinicalTrials.gov

See all 15 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/NCT00957047

GET https://conductscience.org/api/trials/v1/NCT00957047/flow?page=2

API reference For AI assistants