Trial · NCT00700310
Evaluating Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
NCT00700310, Phase 3, Completed, Eisai Inc.; results first posted 2012-11-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluating Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures. Trials, record NCT00700310. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00700310
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluating Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
- NCT number
- NCT00700310
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 712 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Refractory Partial Seizures
- Interventions
- perampanel, perampanel, perampanel, Placebo
- First posted
- 2008-06-18
- Last updated
- 2016-01-21
- Other registries' IDs
- eudract:2007-006169-33
- Results first posted
- 2012-11-22
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases) | Baseline (Pre-randomization) through Week 19 | Seizure frequency per 28 days was derived from the information recorded in the subject diaries. |
| Secondary | Responder Rate | Baseline (Pre-randomization) through Week 19 | The responder rate for the Full ITT Analysis Set from the maintenance LOCF (Last Observation Carried Forward). A responder was a subject who had a 50 percent or greater reduction in seizure frequency per 28 days from the Pre-randomization phase. |
| Secondary | Percent Change in the 28-day Complex Partial Plus Secondarily Generalized Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases) | Baseline (Pre-randomization) through Week 19 | Percent Change in the Seizure frequency per 28 days was derived from the information recorded in the subject diaries. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases) | Baseline (Pre-randomization) through Week 19 | Full Intent-to-Treat (ITT) Analysis Set - group of subjects who were randomized to study drug, received study drug, and had any seizure frequency data during the Double-blind Phase. | Percent Change | MEDIAN |
| SECONDARY | Responder Rate | Baseline (Pre-randomization) through Week 19 | Full ITT Analysis Set. | Percentage of Participants | NUMBER |
| SECONDARY | Percent Change in the 28-day Complex Partial Plus Secondarily Generalized Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases) | Baseline (Pre-randomization) through Week 19 | Full ITT Analysis Set | Percent Change | MEDIAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases) | Placebo | -10.69 | Full Range -100.0 to 420.6 | Percent Change | |
| Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases) | Perampanel 2mg | -13.63 | Full Range -100.0 to 346.3 | Percent Change | |
| Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases) | Perampanel 4mg | -23.33 | Full Range -100.0 to 416.0 | Percent Change | |
| Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases) | Perampanel 8 mg | -30.80 | Full Range -100.0 to 390.6 | Percent Change | |
| Responder Rate | Placebo | Responders (Yes) | 17.9 | Percentage of Participants | |
| Responder Rate | Perampanel 2mg | Responders (Yes) | 20.6 | Percentage of Participants | |
| Responder Rate | Perampanel 4mg | Responders (Yes) | 28.5 | Percentage of Participants | |
| Responder Rate | Perampanel 8 mg | Responders (Yes) | 34.9 | Percentage of Participants | |
| Responder Rate | Placebo | Non-Responders (No) | 82.1 | Percentage of Participants | |
| Responder Rate | Perampanel 2mg | Non-Responders (No) | 79.4 | Percentage of Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 187 | |
| Overall Study | STARTED | Perampanel 2mg | 180 | |
| Overall Study | STARTED | Perampanel 4mg | 174 | |
| Overall Study | STARTED | Perampanel 8 mg | 171 | |
| Overall Study | COMPLETED | Placebo | 166 | |
| Overall Study | COMPLETED | Perampanel 2mg | 154 | |
| Overall Study | COMPLETED | Perampanel 4mg | 158 | |
| Overall Study | COMPLETED | Perampanel 8 mg | 145 | |
| Overall Study | NOT COMPLETED | Placebo | 21 | |
| Overall Study | NOT COMPLETED | Perampanel 2mg | 26 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events164
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 | Fatigue | General disorders | Placebo | 5 | 185 | |
| other | Fatigue | General disorders | Perampanel 2mg | 8 | 180 | |
| other | Fatigue | General disorders | Perampanel 4mg | 13 | 172 | |
| other | Fatigue | General disorders | Perampanel 8 mg | 9 | 169 | |
| other | Gait disturbance | General disorders | Placebo | 2 | 185 | |
| other | Gait disturbance | General disorders | Perampanel 2mg | 1 | 180 | |
| other | Gait disturbance | General disorders | Perampanel 4mg | 2 | 172 | |
| other | Gait disturbance | General disorders | Perampanel 8 mg | 9 | 169 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 3 | 185 | |
| other | Nasopharyngitis | Infections and infestations | Perampanel 2mg | 7 | 180 |
1 to 10 of 164Source ClinicalTrials.gov
See all 164 adverse eventsAdverse event totals12
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 8 mg | ||
| Total, other adverse events | Placebo | 48 | 185 |
| Total, other adverse events | Perampanel 2mg | 61 | 180 |
| Total, other adverse events | Perampanel 4mg | 66 | 172 |
| Total, other adverse events | Perampanel 8 mg | 79 | 169 |
| Total, serious adverse events | Placebo | 9 | 185 |
| Total, serious adverse events | Perampanel 2mg | 6 | 180 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers6
The papers the trial lists on ClinicalTrials.gov.
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/NCT00700310
GET https://conductscience.org/api/trials/v1/NCT00700310/events?page=2