Trial · NCT00981227
Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Post-Herpetic Neuralgia
NCT00981227, Phase 2, Completed, Bial - Portela C S.A.; results first posted 2013-05-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Post-Herpetic Neuralgia. Trials, record NCT00981227. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00981227
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 Therapy for Patients With Post-Herpetic Neuralgia
- NCT number
- NCT00981227
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 567 participants, actual
- Lead sponsor
- Bial - Portela C S.A.
- Conditions
- Postherpetic Neuralgia
- Interventions
- Eslicarbazepine acetate, Placebo
- First posted
- 2009-09-22
- Last updated
- 2014-10-29
- Results first posted
- 2013-05-03
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Mean Pain (NRPS) From Baseline to Endpoint in Mean Pain | baseline and 13 weeks | The primary efficacy variable will be based upon an 11-point (0-10) Numeric Rating Pain Scale (NRPS), where 0 = no pain and 10 = worst possible pain, to be recorded in a patient's diary upon awakening each morning. This score should reflect the patient's mean pain over the previous 24 hours. Please note that the change from baseline to endpoint in mean pain, i.e. the difference between endpoint mean pain and baseline mean pain, which are defined as follows: * Baseline mean pain is defined as the mean of the last four available ratings of average daily pain (NRPS) in the patient diary performed in the last 7 days before randomisation. * Endpoint mean pain is defined as the mean of the last four available ratings of average daily pain in the patient diary in the last 7 days of the treatment period. |
| Other | Change in Mean Pain (NRPS) From Baseline to Endpoint by Total Daily Dose | baseline and 13 weeks | Details of neuropathic pain, as recorded in a subject diary, were used for the primary assessment of analgesic efficacy. Subjects assessed their pain using an 11-point (0 "no pain" to 10 "worst possible pain") NRPS upon awakening each morning and recorded the results in the subject diary. This score reflected the subject's mean pain over the previous 24 hours. Subjects were trained how to record their pain reliably. Investigators were trained in the subject's NRPS use during site initiation visits and at the investigators' meeting. |
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 in Mean Pain (NRPS) From Baseline to Endpoint in Mean Pain | baseline and 13 weeks | Points | LEAST_SQUARES_MEAN | |
| OTHER_PRE_SPECIFIED | Change in Mean Pain (NRPS) From Baseline to Endpoint by Total Daily Dose | baseline and 13 weeks | Points | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Mean Pain (NRPS) From Baseline to Endpoint in Mean Pain | ESL 1200 mg Once Daily | -1.9447 | Standard Error 0.2088 | Points | |
| Change in Mean Pain (NRPS) From Baseline to Endpoint in Mean Pain | ESL 400 mg Twice-daily | -1.9786 | Standard Error 0.2178 | Points | |
| Change in Mean Pain (NRPS) From Baseline to Endpoint in Mean Pain | ESL 600 mg Twice Daily | -1.6798 | Standard Error 0.2179 | Points | |
| Change in Mean Pain (NRPS) From Baseline to Endpoint in Mean Pain | ESL 800 mg Once-daily | -1.6633 | Standard Error 0.2217 | Points | |
| Change in Mean Pain (NRPS) From Baseline to Endpoint in Mean Pain | ESL 800 mg Twice Daily | -2.0834 | Standard Error 0.2280 | Points | |
| Change in Mean Pain (NRPS) From Baseline to Endpoint in Mean Pain | Placebo | -1.5441 | Standard Error 0.2197 | Points | |
| Change in Mean Pain (NRPS) From Baseline to Endpoint by Total Daily Dose | Placebo | -1.5448 | Standard Error 0.2196 | Points | |
| Change in Mean Pain (NRPS) From Baseline to Endpoint by Total Daily Dose | ESL 1200 mg/Day | -1.8183 | Standard Error 0.1512 | Points | |
| Change in Mean Pain (NRPS) From Baseline to Endpoint by Total Daily Dose | ESL 1600 mg/Day | -2.0854 | Standard Error 0.2279 | Points | |
| Change in Mean Pain (NRPS) From Baseline to Endpoint by Total Daily Dose | ESL 800 mg/Day | -1.8236 | Standard Error 0.1565 | Points |
Source ClinicalTrials.gov
Participant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ESL 1200 mg Once Daily | 102 | |
| Overall Study | STARTED | ESL 400 mg Twice-daily | 94 | |
| Overall Study | STARTED | ESL 600 mg Twice Daily | 94 | |
| Overall Study | STARTED | ESL 800 mg Once-daily | 94 | |
| Overall Study | STARTED | ESL 800 mg Twice Daily | 90 | |
| Overall Study | STARTED | Placebo | 93 | |
| Overall Study | Randomized | ESL 1200 mg Once Daily | 102 | |
| Overall Study | Randomized | ESL 400 mg Twice-daily | 94 | |
| Overall Study | Randomized | ESL 600 mg Twice Daily | 94 | |
| Overall Study | Randomized | ESL 800 mg Once-daily | 94 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events288
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 | 9 | 102 | 9 |
| other | Dizziness | Nervous system disorders | ESL 400 mg Twice-daily | 4 | 94 | 4 |
| other | Dizziness | Nervous system disorders | ESL 600 mg Twice Daily | 8 | 94 | 8 |
| other | Dizziness | Nervous system disorders | ESL 800 mg Once-daily | 5 | 94 | 5 |
| other | Dizziness | Nervous system disorders | ESL 800 mg Twice Daily | 11 | 90 | 11 |
| other | Dizziness | Nervous system disorders | Placebo | 2 | 93 | 2 |
| other | Somnolence | Nervous system disorders | ESL 1200 mg Once Daily | 6 | 102 | 6 |
| other | Somnolence | Nervous system disorders | ESL 400 mg Twice-daily | 3 | 94 | 3 |
| other | Somnolence | Nervous system disorders | ESL 600 mg Twice Daily | 2 | 94 | 2 |
| other | Somnolence | Nervous system disorders | ESL 800 mg Once-daily | 1 | 94 | 1 |
1 to 10 of 288Source ClinicalTrials.gov
See all 288 adverse eventsAdverse event totals18
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 Twice-daily | ||
| Total, all-cause mortality | ESL 600 mg Twice Daily | ||
| Total, all-cause mortality | ESL 800 mg Once-daily | ||
| Total, all-cause mortality | ESL 800 mg Twice Daily | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | ESL 1200 mg Once Daily | 48 | 102 |
| Total, other adverse events | ESL 400 mg Twice-daily | 41 | 94 |
| Total, other adverse events | ESL 600 mg Twice Daily | 42 | 94 |
| Total, other adverse events | ESL 800 mg Once-daily | 46 | 94 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
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/NCT00981227
GET https://conductscience.org/api/trials/v1/NCT00981227/flow?page=2