Trial · NCT02427607
An Open-label Extension Study to Evaluate the Safety and Tolerability of Perampanel (E2007) Administered as an Adjunctive Therapy in Epilepsy Subjects
NCT02427607, Phase 3, Completed, Eisai Co., Ltd.; results first posted 2018-07-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Open-label Extension Study to Evaluate the Safety and Tolerability of Perampanel (E2007) Administered as an Adjunctive Therapy in Epilepsy Subjects. Trials, record NCT02427607. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02427607
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-label Extension Study to Evaluate the Safety and Tolerability of Perampanel (E2007) Administered as an Adjunctive Therapy in Epilepsy Subjects
- NCT number
- NCT02427607
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 7 participants, actual
- Lead sponsor
- Eisai Co., Ltd.
- Conditions
- Epilepsy
- Interventions
- Perampanel
- First posted
- 2015-04-28
- Last updated
- 2018-07-02
- Results first posted
- 2018-07-02
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel | From first dose of study drug until perampanel was commercially available, up to approximately 1 year 5 months | Safety was assessed by monitoring adverse events (AEs), withdrawal from treatment, clinical laboratory tests (chemistry), vital signs, and weight. TEAEs were defined as AEs that emerged from the first dose of study drug to the last visit of Study 341 or on or after 30 days since the last dose of study drug in Study 341, whichever comes later, having been absent at pretreatment (Baseline of Study 332). A markedly abnormal clinical chemistry laboratory value was defined as a laboratory result that worsened in severity to meet modified National Cancer Institute (NCI) toxicity criteria of Grade 2 or higher on treatment. Treatment-related TEAEs were defined as AEs that were considered by the investigator to be possibly or probably related to study treatment. SAEs were defined as any untoward medical occurrence that at any dose; resulted in death, disability/incapacity, birth defect, required inpatient hospitalization or prolongation of existing hospitalization, or was life-threatening. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel | From first dose of study drug until perampanel was commercially available, up to approximately 1 year 5 months | Safety analysis set included all participants who signed informed consent and received at least one dose of study drug, and had at least one post-dose safety assessment in Study 341. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel | Perampanel | Non-Serious TEAEs | 6 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel | Perampanel | Treatment-related TEAEs | 0 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel | Perampanel | Severe TEAEs | 0 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel | Perampanel | TEAEs leading to study drug dose adjustment | 0 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel | Perampanel | Serious TEAE | 0 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Perampanel | 7 | |
| Overall Study | COMPLETED | Perampanel | 6 | |
| Overall Study | NOT COMPLETED | Perampanel | 1 |
Source ClinicalTrials.gov
Adverse events8
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 | Nasopharyngitis | Infections and infestations | Perampanel | 3 | 7 | |
| other | Influenza | Infections and infestations | Perampanel | 1 | 7 | |
| other | Fall | Injury, poisoning and procedural complications | Perampanel | 1 | 7 | |
| other | Head injury | Injury, poisoning and procedural complications | Perampanel | 1 | 7 | |
| other | Humerus fracture | Injury, poisoning and procedural complications | Perampanel | 1 | 7 | |
| other | Diabetes mellitus | Metabolism and nutrition disorders | Perampanel | 1 | 7 | |
| other | Hypercholesterolaemia | Metabolism and nutrition disorders | Perampanel | 1 | 7 | |
| other | Hyperuricaemia | Metabolism and nutrition disorders | Perampanel | 1 | 7 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Perampanel | 0 | 7 |
| Total, other adverse events | Perampanel | 6 | 7 |
| Total, serious adverse events | Perampanel | 0 | 7 |
Source ClinicalTrials.gov
Papers0
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/NCT02427607
GET https://conductscience.org/api/trials/v1/NCT02427607/registered