Trial · NCT00988156
Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children
NCT00988156, Phase 3, Completed, Bial - Portela C S.A.; results first posted 2014-07-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children. Trials, record NCT00988156. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00988156
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children
- NCT number
- NCT00988156
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 304 participants, actual
- Lead sponsor
- Bial - Portela C S.A.
- Conditions
- Partial Epilepsy in Children and Adolescents
- Interventions
- Eslicarbazepine acetate (BIA 2-093), Eslicarbazepine acetate
- First posted
- 2009-10-02
- Last updated
- 2018-11-13
- Other registries' IDs
- eudract:2007-001887-55
- Results first posted
- 2014-07-17
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Seizure Frequency | Baseline up to Visit 7 | Relative reduction in the standardised 4-week seizure frequency from the baseline period to the 12-week maintenance period. |
| Primary | Responder Rate | baseline up to Visit 7 | Responder rate defined as the number of patients with at least a 50% decrease in the standardised 4-week seizure frequency from the baseline period to the 12-week maintenance period. |
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 | Change From Baseline in Seizure Frequency | Baseline up to Visit 7 | seizures/month | MEAN | |
| PRIMARY | Responder Rate | baseline up to Visit 7 | participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Seizure Frequency | Placebo | 62.0 | Standard Deviation 186.19 | seizures/month | |
| Change From Baseline in Seizure Frequency | Esl (BIA 2-093) | 36.6 | Standard Deviation 72.47 | seizures/month | |
| Responder Rate | Placebo | 40 | participants | ||
| Responder Rate | Esl (BIA 2-093) | 41 | participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 149 | |
| Overall Study | STARTED | Esl (BIA 2-093) | 155 | |
| Overall Study | Intention-to-Treat Set (ITT) | Placebo | 129 | |
| Overall Study | Intention-to-Treat Set (ITT) | Esl (BIA 2-093) | 134 | |
| Overall Study | Per Protocol Set (PP) | Placebo | 101 | |
| Overall Study | Per Protocol Set (PP) | Esl (BIA 2-093) | 97 | |
| Overall Study | Safety Set | Placebo | 129 | |
| Overall Study | Safety Set | Esl (BIA 2-093) | 134 | |
| Overall Study | COMPLETED | Placebo | 132 | |
| Overall Study | COMPLETED | Esl (BIA 2-093) | 135 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events90
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 | Headache | Nervous system disorders | Placebo (Safety Set Part I) | 8 | 129 | |
| other | Headache | Nervous system disorders | Esl (Safety Set Part I) | 18 | 134 | |
| other | Nasopharyngitis | Infections and infestations | Placebo (Safety Set Part I) | 45 | 129 | |
| other | Nasopharyngitis | Infections and infestations | Esl (Safety Set Part I) | 15 | 134 | |
| other | Somnolence | Nervous system disorders | Placebo (Safety Set Part I) | 6 | 129 | |
| other | Somnolence | Nervous system disorders | Esl (Safety Set Part I) | 15 | 134 | |
| other | Convulsion | Nervous system disorders | Placebo (Safety Set Part I) | 14 | 129 | |
| other | Convulsion | Nervous system disorders | Esl (Safety Set Part I) | 13 | 134 | |
| other | Pyrexia | General disorders | Placebo (Safety Set Part I) | 7 | 129 | |
| other | Pyrexia | General disorders | Esl (Safety Set Part I) | 10 | 134 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (Safety Set Part I) | ||
| Total, all-cause mortality | Esl (Safety Set Part I) | ||
| Total, other adverse events | Placebo (Safety Set Part I) | 94 | 129 |
| Total, other adverse events | Esl (Safety Set Part I) | 112 | 134 |
| Total, serious adverse events | Placebo (Safety Set Part I) | 9 | 129 |
| Total, serious adverse events | Esl (Safety Set Part I) | 15 | 134 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31878820 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Esl (BIA 2-093) vs Placebo: Responder Rate | Trial comparisons |
| Esl (Safety Set Part I) vs Placebo (Safety Set Part I): 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.
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/NCT00988156
GET https://conductscience.org/api/trials/v1/NCT00988156/events?page=2