Trial · NCT00866775
Safety and Efficacy of Eslicarbazepine Acetate Monotherapy in Subjects With Partial Epilepsy Not Well Controlled by Current Antiepileptic Drugs
NCT00866775, Phase 3, Completed, Sumitomo Pharma America, Inc.; results first posted 2016-02-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Eslicarbazepine Acetate Monotherapy in Subjects With Partial Epilepsy Not Well Controlled by Current Antiepileptic Drugs. Trials, record NCT00866775. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00866775
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Eslicarbazepine Acetate Monotherapy in Subjects With Partial Epilepsy Not Well Controlled by Current Antiepileptic Drugs
- NCT number
- NCT00866775
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 193 participants, actual
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Conditions
- Epilepsy With Simple or Complex Partial Onset Seizures
- Interventions
- Eslicarbazepine acetate, Eslicarbazepine acetate
- First posted
- 2009-03-20
- Last updated
- 2016-03-11
- Results first posted
- 2016-02-04
- Limitations and caveats
The comparison of active treatment to control which was used in this trial is based on a pooled analysis of comparator groups from 8 earlier trials of similar design. Limitations related to use of historical control groups are applicable.
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cumulative 112-day Exit Rate as Estimated by Kaplan-Meier Method | Week 3 to Week 18 | Cumulative exit rate was defined as the proportion of subjects meeting at least one of the five exit criteria over a 16-wk study period (start of Antiepilectic Drugs(AED) taper/conv.period (Wk 3 to end of double blind monotherapy period (Wk 18)):1.One episode of status epilepticus.2.One secondary general partial seizure (in subjects who did not have gen. seizures during 6 months prior to screening).3.A two fold increase in any consecutive 28 day seizure rate compared to the highest consecutive 28 day seizure rate during the 8 wk baseline period. 4.A two fold increase in any consecutive 2 day seizure rate compared to the highest consecutive 2 day seizure rate during the 8 wk baseline period. If the highest number of seizures in any consecutive 2 day period during the 8 wk baseline was 1 then 3 seizures in a consecutive 2 day period was required to exit.5.Worsening of seizures or increase in seizure frequency considered serious or requiring intervention as judged by the Investigator. |
| Secondary | Percentage of Subjects That Are Seizure-free During the 10-week Double-blind Monotherapy Treatment Period. | Weeks 9 through 18 | Seizure-free subjects during the monotherapy period were determined as subjects who had seizure assessments during the monotherapy period, and did not have any seizures in the 10 weeks between Visits 6 and 9 (Weeks 9 through 18). Subjects who discontinued during this period were considered not seizure-free even if they were seizure-free at the time of discontinuation, i.e., to be considered seizure-free, subjects must complete the 10-week period without any seizures. |
| Secondary | Percentage of Subjects Seizure-free During the Last 4 Weeks on Eslicarbazepine Acetate Monotherapy. | Weeks 15 through 18 | Seizure-free subjects during the last four weeks of monotherapy were determined as subjects who had seizure assessments during the 4 weeks between Visits 8 and 9 (Weeks 15 through 18), and did not have any seizures. |
| Secondary | Completion Rate | Week 1 to Week 18 | Subjects completing the study were determined as subjects who completed the 18 weeks of double-blind treatment. |
| Secondary | Completion Rate During the 10 Weeks of Monotherapy | Weeks 8 through 18 | Monotherapy completion rate was defined as the proportion (%) of subjects entering the monotherapy period who completed the 10 weeks of monotherapy treatment. |
| Secondary | Time on Eslicarbazepine Acetate Monotherapy. | Week 8 to Week 18 | The start of the monotherapy period was defined as the date of termination of all other AEDs while taking study monotherapy medication. Time on monotherapy was defined from the start of monotherapy period to the last dose of monotherapy treatment. |
| Secondary | Change in Seizure Frequency From Baseline. | Week 0 to Week 18, Double-blind: weeks 1to 18; baseline:weeks-8 to -1; Titration: weeks 1 to 2; AED taper/conversion:weeks 3 to 8; monotherapy: weeks 9 to 18 | The relative (%) change in standardized seizure frequency was evaluated for four periods: titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18). |
| Secondary | Responder Rate (Proportion [%] of Subjects With a ≥50% Reduction of Seizure Frequency From Baseline). | Week 0 to Week 18, Double blind: weeks to 8; baseline:weeks -8 to -1; titration: weeks 1 to 2; AED taper/conversion: weeks 3 to 8; monotherapy: weeks 9 to 18 | Responder rate was defined as the proportion (%) of subjects with a ≥ 50% reduction of seizure frequency from baseline. This analysis was done for the titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18) periods. |
| Secondary | Percentage of Subjects Reaching Each of the Exit Events. | Week 1 to Week 18 | The percentage of subjects reaching each of the 5 exit criteria. 1.One episode of status epilepticus.2.One secondary general partial seizure (in subjects who did not have gen. seizures during 6 months prior to screening).3.A two fold increase in any consecutive 28 day seizure rate compared to the highest consecutive 28 day seizure rate during the 8 wk baseline period. 4.A two fold increase in any consecutive 2 day seizure rate compared to the highest consecutive 2 day seizure rate during the 8 wk baseline period. If the highest number of seizures in any consecutive 2 day period during the 8 wk baseline was 1 then 3 seizures in a consecutive 2 day period was required to exit.5.Worsening of seizures or increase in seizure frequency considered serious or requiring intervention as judged by the Investigator. |
| Secondary | Change in Total Score From Baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31). | Week 0 to Week 18, baseline: day 0: End of AED taper/conversion period: end of week 8; End of monotherapy period: end of week 18 | The QOLIE-31 overall score was obtained by using a weighted average of multi-item scale scores. The recorded responses were converted to 0-100 point scales. The mean of the individual item scores in each subgroup were calculated, with higher converted scores reflecting better quality of life. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cumulative 112-day Exit Rate as Estimated by Kaplan-Meier Method | Week 3 to Week 18 | efficacy population | proportion of participants | NUMBER |
| SECONDARY | Percentage of Subjects That Are Seizure-free During the 10-week Double-blind Monotherapy Treatment Period. | Weeks 9 through 18 | efficacy population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Subjects Seizure-free During the Last 4 Weeks on Eslicarbazepine Acetate Monotherapy. | Weeks 15 through 18 | efficacy population | percentage of participants | NUMBER |
| SECONDARY | Completion Rate | Week 1 to Week 18 | efficacy population | percentage of participants | NUMBER |
| SECONDARY | Completion Rate During the 10 Weeks of Monotherapy | Weeks 8 through 18 | efficacy population | percentage of participants | NUMBER |
| SECONDARY | Time on Eslicarbazepine Acetate Monotherapy. | Week 8 to Week 18 | efficacy population | days | MEDIAN |
| SECONDARY | Change in Seizure Frequency From Baseline. | Week 0 to Week 18, Double-blind: weeks 1to 18; baseline:weeks-8 to -1; Titration: weeks 1 to 2; AED taper/conversion:weeks 3 to 8; monotherapy: weeks 9 to 18 | efficacy population (ESL 1200 mg) Double-blind: 60;Titration: 60; AED taper/conversion: 60; Monotherapy: 43 (ESL 1600 mg) Double-blind: 118; Titration: 118; AED taper/conversion:114; Monotherapy:93 | percent change | MEDIAN |
| SECONDARY | Responder Rate (Proportion [%] of Subjects With a ≥50% Reduction of Seizure Frequency From Baseline). | Week 0 to Week 18, Double blind: weeks to 8; baseline:weeks -8 to -1; titration: weeks 1 to 2; AED taper/conversion: weeks 3 to 8; monotherapy: weeks 9 to 18 | efficacy population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Subjects Reaching Each of the Exit Events. | Week 1 to Week 18 | efficacy population | percentage of participants | NUMBER |
| SECONDARY | Change in Total Score From Baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31). | Week 0 to Week 18, baseline: day 0: End of AED taper/conversion period: end of week 8; End of monotherapy period: end of week 18 | the numbers analyzed represent all participants for whom data were available at baseline (ESL 1200 mg)Change from baseline to end of AED taper/conversion period: 39;Change from baseline to end of monotherapy period:36 (ESL1600 mg) Change from baseline to end of AED taper/conversion period: 86;Change from baseline to end of monotherapy period: 86 | units on a scale | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group94
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cumulative 112-day Exit Rate as Estimated by Kaplan-Meier Method | Eslicarbazepine 1200 mg QD | 0.444 | 95% Confidence Interval 0.3252 to 0.5832 | proportion of participants | |
| Cumulative 112-day Exit Rate as Estimated by Kaplan-Meier Method | Eslicarbazepine 1600 mg QD | 0.287 | 95% Confidence Interval 0.2124 to 0.3813 | proportion of participants | |
| Percentage of Subjects That Are Seizure-free During the 10-week Double-blind Monotherapy Treatment Period. | Eslicarbazepine 1200 mg QD | 8.3 | 95% Confidence Interval 2.8 to 18.4 | percentage of participants | |
| Percentage of Subjects That Are Seizure-free During the 10-week Double-blind Monotherapy Treatment Period. | Eslicarbazepine 1600 mg QD | 7.6 | 95% Confidence Interval 3.5 to 14.0 | percentage of participants | |
| Percentage of Subjects Seizure-free During the Last 4 Weeks on Eslicarbazepine Acetate Monotherapy. | Eslicarbazepine 1200 mg QD | 13.3 | 95% Confidence Interval 5.9 to 24.6 | percentage of participants | |
| Percentage of Subjects Seizure-free During the Last 4 Weeks on Eslicarbazepine Acetate Monotherapy. | Eslicarbazepine 1600 mg QD | 14.4 | 95% Confidence Interval 8.6 to 22.1 | percentage of participants | |
| Completion Rate | Eslicarbazepine 1200 mg QD | 48.3 | 95% Confidence Interval 35.2 to 61.6 | percentage of participants | |
| Completion Rate | Eslicarbazepine 1600 mg QD | 64.4 | 95% Confidence Interval 55.1 to 73.0 | percentage of participants | |
| Completion Rate During the 10 Weeks of Monotherapy | Eslicarbazepine 1200 mg QD | 64.4 | 95% Confidence Interval 48.8 to 78.1 | percentage of participants | |
| Completion Rate During the 10 Weeks of Monotherapy | Eslicarbazepine 1600 mg QD | 81.7 | 95% Confidence Interval 72.4 to 89.0 | percentage of participants |
1 to 10 of 94Source ClinicalTrials.gov
See all 94 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Eslicarbazepine 1200 mg QD | 65 | |
| Overall Study | STARTED | Eslicarbazepine 1600 mg QD | 128 | |
| Overall Study | COMPLETED | Eslicarbazepine 1200 mg QD | 29 | |
| Overall Study | COMPLETED | Eslicarbazepine 1600 mg QD | 76 | |
| Overall Study | NOT COMPLETED | Eslicarbazepine 1200 mg QD | 36 | |
| Overall Study | NOT COMPLETED | Eslicarbazepine 1600 mg QD | 52 |
Source ClinicalTrials.gov
Adverse events82
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 | Diplopia | Eye disorders | Eslicarbazepine 1200 mg QD | 5 | 65 | 5 |
| other | Diplopia | Eye disorders | Eslicarbazepine 1600 mg QD | 6 | 128 | 6 |
| other | Vision blurred | Eye disorders | Eslicarbazepine 1200 mg QD | 6 | 65 | 6 |
| other | Vision blurred | Eye disorders | Eslicarbazepine 1600 mg QD | 12 | 128 | 15 |
| other | Abdominal discomfort | Gastrointestinal disorders | Eslicarbazepine 1200 mg QD | 4 | 65 | 6 |
| other | Abdominal discomfort | Gastrointestinal disorders | Eslicarbazepine 1600 mg QD | 4 | 128 | 4 |
| other | Diarrhoea | Gastrointestinal disorders | Eslicarbazepine 1200 mg QD | 5 | 65 | 6 |
| other | Diarrhoea | Gastrointestinal disorders | Eslicarbazepine 1600 mg QD | 9 | 128 | 12 |
| other | Nausea | Gastrointestinal disorders | Eslicarbazepine 1200 mg QD | 7 | 65 | 9 |
| other | Nausea | Gastrointestinal disorders | Eslicarbazepine 1600 mg QD | 18 | 128 | 28 |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Eslicarbazepine 1200 mg QD | ||
| Total, all-cause mortality | Eslicarbazepine 1600 mg QD | ||
| Total, other adverse events | Eslicarbazepine 1200 mg QD | 46 | 65 |
| Total, other adverse events | Eslicarbazepine 1600 mg QD | 100 | 128 |
| Total, serious adverse events | Eslicarbazepine 1200 mg QD | 4 | 65 |
| Total, serious adverse events | Eslicarbazepine 1600 mg QD | 8 | 128 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25689448 | BACKGROUND |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Eslicarbazepine 1200 mg QD vs Eslicarbazepine 1600 mg QD: serious adverse events |
Source 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.
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