Trial · NCT00505284
An Evaluation of the Efficacy and Safety of E2007 in Patients With Painful Diabetic Neuropathy
NCT00505284, Phase 2, Phase 3, Completed, Eisai Inc.; results first posted 2013-02-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Evaluation of the Efficacy and Safety of E2007 in Patients With Painful Diabetic Neuropathy. Trials, record NCT00505284. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00505284
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Evaluation of the Efficacy and Safety of E2007 in Patients With Painful Diabetic Neuropathy
- NCT number
- NCT00505284
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 352 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Diabetic Neuropathy
- Interventions
- Placebo, E2007 (2 mg), E2007 (4 mg), E2007 (6 mg), E2007 (8 mg)
- First posted
- 2007-07-23
- Last updated
- 2014-07-11
- Other registries' IDs
- eudract:2006-006488-22
- Results first posted
- 2013-02-08
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Average Pain Scores From Baseline to Week 15/End of Treatment (EOT) | Baseline to Week 15/EOT | Average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified baseline observation carried forward (BOCF). |
| Primary | Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 30% Reduction in Pain Score | Baseline to Week 15/EOT | Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified BOCF. |
| Primary | Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 50% Reduction in Pain Score | Baseline to Week 15/EOT | Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified BOCF. |
| Primary | Mean Change in Average Pain Scores From Baseline at Each Study Week | Baseline, Week 1 to Week 17 | Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). Last on-treatment value refers to last 7 days of available diary data while subject was on double-blind study drug. |
| Secondary | Change in Average Sleep Interference Scores From Baseline to Week 15/EOT | Baseline to Week 15/EOT | Average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for sleep interference (0=pain did not interfere with sleep, to 10=pain completely interfered with sleep \[unable to sleep\]). Based on modified BOCF. |
| Secondary | Change in Short Form - McGill Pain Questionnaire (SF-MPQ) From Baseline to Week 15/EOT | Baseline and Week 15/EOT | SF-MPQ sensory score = sum of intensity scores for descriptors 1-11 (throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting). Each descriptor scored as 0=none, 1=mild, 2=moderate, or 3=severe. Range of possible sensory scores, 0 to 33, with a score of 33 being the most severe intensity. |
| Secondary | Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | Week 15/EOT | At the EOT (Visit 7) or Early Withdrawal Visit (as appropriate), the subject assessed his/her status compared to how they felt before entering the study. This assessment included an evaluation of pain frequency and intensity, the occurrence of AEs, and overall functional status using a 7-point scale where 1=very much improved and 7=very much worse. Using Modified BOCF. |
| Secondary | Change From Baseline to Week 15/EOT in SF-36 Physical and Mental Component Scores | Baseline and Week 15/EOT | Short Form 36 Health Survey Questionnaire (SF-36) measuring limitations in Physical Components including physical activities, usual role activities (due to physical problems), measuring bodily pain, general health perceptions, and Mental Components including social activities, usual role activities (due to emotional problems), vitality (energy and fatigue. Each of the 8 domains are described by a score ranging from 0 to 100, for a range of total possible scores of 0-400 for physical and 0-400 for mental. Higher scores reflect better subject status. |
| Secondary | Change From Baseline to Week 15/EOT in Hospital Anxiety and Depression Scale (HADS) Anxiety and Depression Subscale Scores | Baseline and Week 15/EOT | HADS anxiety subscale score=sum of scores for 7 anxiety items, each scored on a 4-pt scale (0, 1, 2, or 3), where a higher score indicates worse anxiety. Range of possible HADS anxiety subscale scores, 0 to 21. HADS depression subscale score=sum of scores for 7 depression items, each scored on a 4-pt scale (0, 1, 2, or 3), where a higher score indicates worse depression. Range of possible HADS depression subscale scores, 0 to 21. |
| Secondary | Withdrawal Due to Treatment Failure During Double-Blind Dosing Period | Baseline and Week 15 | Based on data reported on the End of Study case report form (CRF): If a subject terminated the study early during the Double-blind Dosing Period due to 'lack of therapeutic efficacy,' the subject was counted as a withdrawal due to treatment failure. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Average Pain Scores From Baseline to Week 15/End of Treatment (EOT) | Baseline to Week 15/EOT | Intent-to-Treat (ITT) Population - Randomized subjects who took at least 1 dose of study drug and had at least 1 efficacy assessment at Baseline. | Scores on a Scale | MEAN |
| PRIMARY | Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 30% Reduction in Pain Score | Baseline to Week 15/EOT | ITT Population. A responder was defined as a subject who had at least a 30% reduction in average pain scores from Baseline to Week 15/EOT. | Percentage of Participants | NUMBER |
| PRIMARY | Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 50% Reduction in Pain Score | Baseline to Week 15/EOT | ITT Population. A responder was defined as a subject who had at least a 50% reduction in average pain scores from Baseline to Week 15/EOT. | Percentage of Participants | NUMBER |
| PRIMARY | Mean Change in Average Pain Scores From Baseline at Each Study Week | Baseline, Week 1 to Week 17 | ITT Population | Scores on a Scale | MEAN |
| SECONDARY | Change in Average Sleep Interference Scores From Baseline to Week 15/EOT | Baseline to Week 15/EOT | ITT Population | Scores on a Scale | MEAN |
| SECONDARY | Change in Short Form - McGill Pain Questionnaire (SF-MPQ) From Baseline to Week 15/EOT | Baseline and Week 15/EOT | ITT Population | Scores on a Scale | MEAN |
| SECONDARY | Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | Week 15/EOT | Subset of ITT population used, including subjects that completed PGIC at Week 15 visit, and using BOCF (baseline observation carried forward) subjects that terminated prior to Week 15 received a 'No Change' if due to AE or Lack of Therapeutic Efficacy, subjects who discontinued due to other reasons used PGIC scores from Early Termination visit. | Participants | NUMBER |
| SECONDARY | Change From Baseline to Week 15/EOT in SF-36 Physical and Mental Component Scores | Baseline and Week 15/EOT | ITT Population | Scores on a Scale | MEAN |
| SECONDARY | Change From Baseline to Week 15/EOT in Hospital Anxiety and Depression Scale (HADS) Anxiety and Depression Subscale Scores | Baseline and Week 15/EOT | ITT Population | Scores on a Scale | MEAN |
| SECONDARY | Withdrawal Due to Treatment Failure During Double-Blind Dosing Period | Baseline and Week 15 | ITT Population | Participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group205
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Average Pain Scores From Baseline to Week 15/End of Treatment (EOT) | Placebo | -2.22 | Standard Deviation 2.19 | Scores on a Scale | |
| Change in Average Pain Scores From Baseline to Week 15/End of Treatment (EOT) | Perampanel 2mg | -1.73 | Standard Deviation 2.34 | Scores on a Scale | |
| Change in Average Pain Scores From Baseline to Week 15/End of Treatment (EOT) | Perampanel 4mg | -1.30 | Standard Deviation 2.18 | Scores on a Scale | |
| Change in Average Pain Scores From Baseline to Week 15/End of Treatment (EOT) | Perampanel 6mg | -1.85 | Standard Deviation 2.01 | Scores on a Scale | |
| Change in Average Pain Scores From Baseline to Week 15/End of Treatment (EOT) | Perampanel 8mg | -1.18 | Standard Deviation 2.00 | Scores on a Scale | |
| Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 30% Reduction in Pain Score | Placebo | Responders (Yes) | 56.3 | Percentage of Participants | |
| Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 30% Reduction in Pain Score | Perampanel 2mg | Responders (Yes) | 36.6 | Percentage of Participants | |
| Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 30% Reduction in Pain Score | Perampanel 4mg | Responders (Yes) | 32.4 | Percentage of Participants | |
| Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 30% Reduction in Pain Score | Perampanel 6mg | Responders (Yes) | 39.4 | Percentage of Participants | |
| Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 30% Reduction in Pain Score | Perampanel 8mg | Responders (Yes) | 31.9 | Percentage of Participants |
1 to 10 of 205Source ClinicalTrials.gov
See all 205 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 73 | |
| Overall Study | STARTED | Perampanel 2mg | 72 | |
| Overall Study | STARTED | Perampanel 4mg | 69 | |
| Overall Study | STARTED | Perampanel 6mg | 68 | |
| Overall Study | STARTED | Perampanel 8mg | 70 | |
| Overall Study | COMPLETED | Placebo | 63 | |
| Overall Study | COMPLETED | Perampanel 2mg | 56 | |
| Overall Study | COMPLETED | Perampanel 4mg | 57 | |
| Overall Study | COMPLETED | Perampanel 6mg | 49 | |
| Overall Study | COMPLETED | Perampanel 8mg | 37 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events310
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 | Diarrhoea | Gastrointestinal disorders | Placebo | 2 | 71 | |
| other | Diarrhoea | Gastrointestinal disorders | Perampanel 2mg | 3 | 71 | |
| other | Diarrhoea | Gastrointestinal disorders | Perampanel 4mg | 1 | 68 | |
| other | Diarrhoea | Gastrointestinal disorders | Perampanel 6mg | 2 | 67 | |
| other | Diarrhoea | Gastrointestinal disorders | Perampanel 8mg | 4 | 68 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 2 | 71 | |
| other | Nausea | Gastrointestinal disorders | Perampanel 2mg | 4 | 71 | |
| other | Nausea | Gastrointestinal disorders | Perampanel 4mg | 2 | 68 | |
| other | Nausea | Gastrointestinal disorders | Perampanel 6mg | 5 | 67 | |
| other | Nausea | Gastrointestinal disorders | Perampanel 8mg | 5 | 68 |
1 to 10 of 310Source ClinicalTrials.gov
See all 310 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Perampanel 2mg | ||
| Total, all-cause mortality | Perampanel 4mg | ||
| Total, all-cause mortality | Perampanel 6mg | ||
| Total, all-cause mortality | Perampanel 8mg | ||
| Total, other adverse events | Placebo | 26 | 71 |
| Total, other adverse events | Perampanel 2mg | 30 | 71 |
| Total, other adverse events | Perampanel 4mg | 33 | 68 |
| Total, other adverse events | Perampanel 6mg | 40 | 67 |
| Total, other adverse events | Perampanel 8mg | 38 | 68 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 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/NCT00505284
GET https://conductscience.org/api/trials/v1/NCT00505284/results?page=2