Trial · NCT01091662
Safety & Efficacy of Eslicarbazepine Monotherapy in Sub.w/Partial Epilepsy Not Well Controlled by Current Antiepileptic
NCT01091662, Phase 3, Completed, Sumitomo Pharma America, Inc.; results first posted 2015-12-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety & Efficacy of Eslicarbazepine Monotherapy in Sub.w/Partial Epilepsy Not Well Controlled by Current Antiepileptic. Trials, record NCT01091662. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01091662
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety & Efficacy of Eslicarbazepine Monotherapy in Sub.w/Partial Epilepsy Not Well Controlled by Current Antiepileptic
- NCT number
- NCT01091662
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 172 participants, actual
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Conditions
- Epilepsy
- Interventions
- Eslicarbazepine acetate 1600 mg, Eslicarbazepine acetate 1200 mg
- First posted
- 2010-03-24
- Last updated
- 2016-10-24
- Results first posted
- 2015-12-21
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 | From beginning of Week 3 to end of Week 18 | Cumulative exit rate was defined as the proportion of subjects meeting at least one of the following five exit criteria over a 16-week study period (from start of AED taper/con. period (Wk 3) to end of double blind monotherapy period (Wk 18)).1.One episode of status epilepticus.2.One secondary gen. partial seizure (in subjects who did not have gen.seizures during 6 mo. 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 week 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 week baseline period. If the highest number of seizures in any consecutive 2 day period during the 8 week 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 | Proportion (%) of Subjects That Are Seizure-free During the 10-week Double-blind Monotherapy Treatment Period. | Week 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. | Week 15 through 18 | Percentage of participants that were Seizure-free 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 (% of Subjects Completing the 18 Weeks of Double-blind Treatment). | 18 weeks | 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 (% of Subjects Entering the Monotherapy Period Who Complete). | Week 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. | 18 weeks, Double-blind:weeks 1-18; Baseline: weeks -8to -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 1-18; baseline: weeks -8 to -1; Titration: weeks 1-2; AED taper/conversion; weeks 3-8; monotherapy weeks 9-18 | 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 | Proportion (%) of Subjects Reaching Each Exit Criteria | Week 1 to Week 18, (beginning of week 1 to end of week 18) | The proportion (%) of subjects reaching each of the 5 exit criteria-1.One episode of status epilepticus.2.One secondary gen. partial seizure (in subjects who did not have gen.seizures during 6 mo. 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 week 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 week baseline period. If the highest number of seizures in any consecutive 2 day period during the 8 week 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 | From beginning of Week 3 to end of Week 18 | Efficacy population | proportion of participants | NUMBER |
| SECONDARY | Proportion (%) of Subjects That Are Seizure-free During the 10-week Double-blind Monotherapy Treatment Period. | Week 9 through 18 | Efficacy population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Subjects Seizure-free During the Last 4 Weeks on Eslicarbazepine Acetate Monotherapy. | Week 15 through 18 | Efficacy population | percentage of participants | NUMBER |
| SECONDARY | Completion Rate (% of Subjects Completing the 18 Weeks of Double-blind Treatment). | 18 weeks | Efficacy population | percentage of participants | NUMBER |
| SECONDARY | Completion Rate During the 10 Weeks of Monotherapy (% of Subjects Entering the Monotherapy Period Who Complete). | Week 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. | 18 weeks, Double-blind:weeks 1-18; Baseline: weeks -8to -1; titration: weeks 1 to 2; AED taper/conversion: weeks 3 to 8; monotherapy; weeks 9 to 18 | Efficacy population (ESL 1200mg) Double-blind: 54; Titration: 54; AED taper/conversion:54; Monotherapy: 48 (ESL1600 mg) Double-blind:98; Titration: 98; AED taper/conversion: 98; Monotherapy: 87 | 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 1-18; baseline: weeks -8 to -1; Titration: weeks 1-2; AED taper/conversion; weeks 3-8; monotherapy weeks 9-18 | Efficacy population | percentage of participants | NUMBER |
| SECONDARY | Proportion (%) of Subjects Reaching Each Exit Criteria | Week 1 to Week 18, (beginning of week 1 to end of 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 | Efficacy Population (ESL 1200 mg) Change from baseline to end of AED taper/conversion period: 45; Change from baseline to end of monotherapy period:50 (ESL1600 mg) Change from baseline to end of AED taper/conversion period: 85; Change from baseline to end of monotherapy period:96 | 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 | ESL1200 mg | 0.156 | 95% Confidence Interval 0.0810 to 0.2874 | proportion of participants | |
| Cumulative 112-day Exit Rate as Estimated by Kaplan-Meier Method | ESL 1600 mg | 0.128 | 95% Confidence Interval 0.0750 to 0.2152 | proportion of participants | |
| Proportion (%) of Subjects That Are Seizure-free During the 10-week Double-blind Monotherapy Treatment Period. | ESL1200 mg | 7.4 | 95% Confidence Interval 2.1 to 17.9 | percentage of participants | |
| Proportion (%) of Subjects That Are Seizure-free During the 10-week Double-blind Monotherapy Treatment Period. | ESL 1600 mg | 10.0 | 95% Confidence Interval 4.9 to 17.6 | percentage of participants | |
| Percentage of Subjects Seizure-free During the Last 4 Weeks on Eslicarbazepine Acetate Monotherapy. | ESL1200 mg | 16.7 | 95% Confidence Interval 7.9 to 29.3 | percentage of participants | |
| Percentage of Subjects Seizure-free During the Last 4 Weeks on Eslicarbazepine Acetate Monotherapy. | ESL 1600 mg | 17.0 | 95% Confidence Interval 10.2 to 25.8 | percentage of participants | |
| Completion Rate (% of Subjects Completing the 18 Weeks of Double-blind Treatment). | ESL1200 mg | 75.9 | 95% Confidence Interval 62.4 to 86.5 | percentage of participants | |
| Completion Rate (% of Subjects Completing the 18 Weeks of Double-blind Treatment). | ESL 1600 mg | 80.0 | 95% Confidence Interval 70.8 to 87.3 | percentage of participants | |
| Completion Rate During the 10 Weeks of Monotherapy (% of Subjects Entering the Monotherapy Period Who Complete). | ESL1200 mg | 85.4 | 95% Confidence Interval 72.2 to 93.9 | percentage of participants | |
| Completion Rate During the 10 Weeks of Monotherapy (% of Subjects Entering the Monotherapy Period Who Complete). | ESL 1600 mg | 90.9 | 95% Confidence Interval 82.9 to 96.0 | 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 | ESL 1200 mg | 58 | |
| Overall Study | STARTED | ESL1600 mg | 114 | |
| Overall Study | COMPLETED | ESL 1200 mg | 41 | |
| Overall Study | COMPLETED | ESL1600 mg | 80 | |
| Overall Study | NOT COMPLETED | ESL 1200 mg | 17 | |
| Overall Study | NOT COMPLETED | ESL1600 mg | 34 |
Source ClinicalTrials.gov
Adverse events42
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 | Nausea | Gastrointestinal disorders | ESL1200 mg | 6 | 58 | 8 |
| other | Nausea | Gastrointestinal disorders | ESL 1600 mg | 7 | 114 | 12 |
| other | Fatigue | General disorders | ESL1200 mg | 4 | 58 | 5 |
| other | Fatigue | General disorders | ESL 1600 mg | 6 | 114 | 7 |
| other | Influenza | Infections and infestations | ESL1200 mg | 3 | 58 | 3 |
| other | Influenza | Infections and infestations | ESL 1600 mg | 1 | 114 | 1 |
| other | Nasopharyngitis | Infections and infestations | ESL1200 mg | 4 | 58 | 4 |
| other | Nasopharyngitis | Infections and infestations | ESL 1600 mg | 9 | 114 | 9 |
| other | Back pain | Musculoskeletal and connective tissue disorders | ESL1200 mg | 3 | 58 | 3 |
| other | Back pain | Musculoskeletal and connective tissue disorders | ESL 1600 mg | 6 | 114 | 7 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ESL1200 mg | ||
| Total, all-cause mortality | ESL 1600 mg | ||
| Total, other adverse events | ESL1200 mg | 29 | 58 |
| Total, other adverse events | ESL 1600 mg | 64 | 114 |
| Total, serious adverse events | ESL1200 mg | 1 | 58 |
| Total, serious adverse events | ESL 1600 mg | 8 | 114 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25880756 | 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 |
|---|
| ESL1200 mg vs ESL 1600 mg: 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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