Trial · NCT01618695
A Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures
NCT01618695, Phase 3, Completed, Eisai Co., Ltd.; results first posted 2020-06-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures. Trials, record NCT01618695. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01618695
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures
- NCT number
- NCT01618695
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 940 participants, actual
- Lead sponsor
- Eisai Co., Ltd.
- Conditions
- Partial-onset Seizures
- Interventions
- Perampanel, Placebo
- First posted
- 2012-06-13
- Last updated
- 2021-07-29
- Results first posted
- 2020-06-05
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Core Phase: Percent Change in Seizure Frequency (For All Partial Seizures) Per 28 Days in the Randomization Phase Relative to Pre-randomization Phase (Baseline) | Baseline, Week 19 | Seizure frequency was based on number of seizures per 28 days, calculated as the number of seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. All partial seizure included simple partial seizures without motor signs, simple partial with motor signs, complex partial, and complex partial with secondary generalized seizures. A simple partial seizure takes place on one side of the brain. Usually, people experiencing a simple partial seizure do not lose consciousness or awareness. A complex partial seizure is a type of seizure that arises in one lobe of the brain, rather than the whole brain. The seizure affects people's awareness and may cause them to lose consciousness. |
| Secondary | Core Phase: Responder Rate During the Maintenance Period of the Randomization Phase Relative to the Prerandomization Phase (Baseline)- Last Observation Carried Forward (LOCF) | Baseline, Week 19 | Responder rate was percentage of participants with greater than or equal to (\>=) 50% reduction in seizure frequency during maintenance period of the randomization phase relative to prerandomization phase (baseline). If the reduction in seizure frequency is less than (\<) 50%, then the participants are considered as non-responders. |
| Secondary | Core Phase: Percent Change in Seizure Frequency Per 28 Days For Complex Partial Seizures Plus Secondary Generalized Seizures in the Randomization Phase Relative to the Prerandomization Phase (Baseline) | Baseline, Week 19 | Seizure frequency was based on number of seizures per 28 days, calculated as the number of seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. A complex partial seizure is a type of seizure that arises in one lobe of the brain, rather than the whole brain and it affects awareness and may cause in loss of consciousness. Secondary generalized seizures begin in one part of the brain, but then spread to both sides of the brain. |
| Secondary | Core Phase: Number of Participants With Clinical Global Impression of Change (CGIC) Scores | Baseline, Week 19 | The investigator evaluated each participant for CGIC questionnaire to assess change in participant's disease clinical status from baseline. Assessment evaluated frequency of seizures, severity of seizures, occurrence of adverse events (AEs), and overall functional status of the participant using the 7-point scale. The evaluation used a 7-point scale with the scores 1: Very much improved, 2: Much improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse. Lower score indicated improvement and higher score indicated worsening. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Core Phase: Percent Change in Seizure Frequency (For All Partial Seizures) Per 28 Days in the Randomization Phase Relative to Pre-randomization Phase (Baseline) | Baseline, Week 19 | Intent-to-treat (ITT) Analysis Set included all participants who signed informed consent, were randomized, received at least one dose of study medication, and had at least one postdose seizure frequency data. | percent change | MEDIAN |
| SECONDARY | Core Phase: Responder Rate During the Maintenance Period of the Randomization Phase Relative to the Prerandomization Phase (Baseline)- Last Observation Carried Forward (LOCF) | Baseline, Week 19 | ITT Analysis Set included all participants who signed informed consent, were randomized, received at least one dose of study medication, and had at least one postdose seizure frequency data. | percentage of participants | NUMBER |
| SECONDARY | Core Phase: Percent Change in Seizure Frequency Per 28 Days For Complex Partial Seizures Plus Secondary Generalized Seizures in the Randomization Phase Relative to the Prerandomization Phase (Baseline) | Baseline, Week 19 | ITT Analysis Set included all participants who signed informed consent, were randomized, received at least one dose of study medication, and had at least one postdose seizure frequency data. Here overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | percent change | MEDIAN |
| SECONDARY | Core Phase: Number of Participants With Clinical Global Impression of Change (CGIC) Scores | Baseline, Week 19 | ITT Analysis Set included all participants who signed informed consent, were randomized, received at least one dose of study medication, and had at least one postdose seizure frequency data. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Core Phase: Percent Change in Seizure Frequency (For All Partial Seizures) Per 28 Days in the Randomization Phase Relative to Pre-randomization Phase (Baseline) | Placebo | -10.76 | Full Range -90.4 to 400.0 | percent change | |
| Core Phase: Percent Change in Seizure Frequency (For All Partial Seizures) Per 28 Days in the Randomization Phase Relative to Pre-randomization Phase (Baseline) | Perampanel 4 mg | -17.32 | Full Range -97.1 to 473.4 | percent change | |
| Core Phase: Percent Change in Seizure Frequency (For All Partial Seizures) Per 28 Days in the Randomization Phase Relative to Pre-randomization Phase (Baseline) | Perampanel 8 mg | -28.95 | Full Range -100.0 to 809.4 | percent change | |
| Core Phase: Percent Change in Seizure Frequency (For All Partial Seizures) Per 28 Days in the Randomization Phase Relative to Pre-randomization Phase (Baseline) | Perampanel 12 mg | -38.03 | Full Range -100.0 to 456.8 | percent change | |
| Core Phase: Responder Rate During the Maintenance Period of the Randomization Phase Relative to the Prerandomization Phase (Baseline)- Last Observation Carried Forward (LOCF) | Placebo | 19.4 | percentage of participants | ||
| Core Phase: Responder Rate During the Maintenance Period of the Randomization Phase Relative to the Prerandomization Phase (Baseline)- Last Observation Carried Forward (LOCF) | Perampanel 4 mg | 23.0 | percentage of participants | ||
| Core Phase: Responder Rate During the Maintenance Period of the Randomization Phase Relative to the Prerandomization Phase (Baseline)- Last Observation Carried Forward (LOCF) | Perampanel 8 mg | 36.0 | percentage of participants | ||
| Core Phase: Responder Rate During the Maintenance Period of the Randomization Phase Relative to the Prerandomization Phase (Baseline)- Last Observation Carried Forward (LOCF) | Perampanel 12 mg | 43.3 | percentage of participants | ||
Core Phase: Percent Change in Seizure Frequency Per 28 Days For Complex Partial Seizures Plus Secondary Generalized Seizures in the Randomization Phase Relative to the Prerandomization Phase (Baseline) | Placebo | -11.70 | Full Range -88.6 to 400.0 | percent change | |
Core Phase: Percent Change in Seizure Frequency Per 28 Days For Complex Partial Seizures Plus Secondary Generalized Seizures in the Randomization Phase Relative to the Prerandomization Phase (Baseline) | Perampanel 4 mg | -19.08 | Full Range -100.0 to 410.0 | percent change |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Core Phase | STARTED | Core Phase: Placebo; Extension Phase: up to 12 mg Perampanel | 177 | |
| Core Phase | STARTED | Core Phase: Perampanel 4 mg; Extension Phase: up to 12 mg Perampanel | 176 | |
| Core Phase | STARTED | Core Phase: Perampanel 8 mg; Extension Phase: up to 12 mg Perampanel | 177 | |
| Core Phase | STARTED | Core Phase/Extension Phase: up to 12 mg Perampanel | 180 | |
| Core Phase | Treated (Safety Analysis Set) | Core Phase: Placebo; Extension Phase: up to 12 mg Perampanel | 176 | |
| Core Phase | Treated (Safety Analysis Set) | Core Phase: Perampanel 4 mg; Extension Phase: up to 12 mg Perampanel | 176 | |
| Core Phase | Treated (Safety Analysis Set) | Core Phase: Perampanel 8 mg; Extension Phase: up to 12 mg Perampanel | 175 | |
| Core Phase | Treated (Safety Analysis Set) | Core Phase/Extension Phase: up to 12 mg Perampanel | 180 | |
| Core Phase | COMPLETED | Core Phase: Placebo; Extension Phase: up to 12 mg Perampanel | 152 | |
| Core Phase | COMPLETED | Core Phase: Perampanel 4 mg; Extension Phase: up to 12 mg Perampanel | 156 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events3,725
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 | Anaemia | Blood and lymphatic system disorders | Core Phase: Placebo | 1 | 176 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Core Phase: Perampanel 4 mg | 0 | 176 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Core Phase: Perampanel 8 mg | 0 | 175 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Core Phase: Perampanel 12 mg | 2 | 180 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Extension Phase: Perampanel 12 mg | 12 | 679 | 13 |
| other | Lymphadenitis | Blood and lymphatic system disorders | Core Phase: Placebo | 0 | 176 | 0 |
| other | Lymphadenitis | Blood and lymphatic system disorders | Core Phase: Perampanel 4 mg | 0 | 176 | 0 |
| other | Lymphadenitis | Blood and lymphatic system disorders | Core Phase: Perampanel 8 mg | 2 | 175 | 2 |
| other | Lymphadenitis | Blood and lymphatic system disorders | Core Phase: Perampanel 12 mg | 0 | 180 | 0 |
| other | Lymphadenitis | Blood and lymphatic system disorders | Extension Phase: Perampanel 12 mg | 2 | 679 | 2 |
1 to 10 of 3,725Source ClinicalTrials.gov
See all 3,725 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Core Phase: Placebo | 1 | 176 |
| Total, all-cause mortality | Core Phase: Perampanel 4 mg | 0 | 176 |
| Total, all-cause mortality | Core Phase: Perampanel 8 mg | 1 | 175 |
| Total, all-cause mortality | Core Phase: Perampanel 12 mg | 0 | 180 |
| Total, all-cause mortality | Extension Phase: Perampanel 12 mg | 7 | 679 |
| Total, other adverse events | Core Phase: Placebo | 114 | 176 |
| Total, other adverse events | Core Phase: Perampanel 4 mg | 119 | 176 |
| Total, other adverse events | Core Phase: Perampanel 8 mg | 127 | 175 |
| Total, other adverse events | Core Phase: Perampanel 12 mg | 155 | 180 |
| Total, other adverse events | Extension Phase: Perampanel 12 mg | 618 | 679 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
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.
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