Trial · NCT02914314
Pharmacokinetic Study With an Oral Suspension of Perampanel as Adjunctive Therapy in Pediatric Subjects With Epilepsy
NCT02914314, Phase 2, Completed, Eisai Inc.; results first posted 2023-09-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pharmacokinetic Study With an Oral Suspension of Perampanel as Adjunctive Therapy in Pediatric Subjects With Epilepsy. Trials, record NCT02914314. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02914314
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacokinetic Study With an Oral Suspension of Perampanel as Adjunctive Therapy in Pediatric Subjects With Epilepsy
- NCT number
- NCT02914314
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 26 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Epilepsy
- Interventions
- perampanel
- First posted
- 2016-09-26
- Last updated
- 2024-03-15
- Results first posted
- 2023-09-15
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose Normalized Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of Perampanel During the Maintenance Period of the Core Phase for Non-EIAED Participants | Maintenance Period of the Core Phase- Days 99 and 113: 1-5 hours post-dose (Cohort 1, Cohort 2, Cohort 3); Days 99 and 113: Pre-dose, 1-5 hours post-dose (Cohort 4) | Dose normalized AUCtau,ss was calculated as AUCtau,ss/maintenance dose, where AUCtau,ss is the area under the curve during a dosing interval (tau, 24 hours) at steady state calculated using population pharmacokinetic (PK) model. PK sparse sampling was performed. One sample was collected at anytime between 1 to 5 hours post-dose on Days 99 and 113 (Cohort 1, Cohort 2, Cohort 3) and two samples were collected, one at pre-dose and other at anytime between 1 to 5 hours post-dose on Days 99 and 113 (Cohort 4). Plasma concentrations of perampanel were measured and concentration data were summarized. Plasma concentrations of perampanel were quantified using a validated liquid chromatography mass spectrometry (LC MS/MS) analytical method. |
| Primary | Dose Normalized Maximum (Peak) Steady-state Concentration (Cmax,ss) of Perampanel During the Maintenance Period of the Core Phase for Non-EIAED Participants | Maintenance Period of the Core Phase- Days 99 and 113: 1-5 hours post-dose (Cohort 1, Cohort 2, Cohort 3); Days 99 and 113: Pre-dose, 1-5 hours post-dose (Cohort 4) | Dose normalized Cmax,ss was calculated as Cmax,ss/maintenance dose, where Cmax,ss is the maximum (peak) steady-state concentration calculated using population PK model. PK sparse sampling was performed. One sample was collected at anytime between 1 to 5 hours post-dose on Days 99 and 113 (Cohort 1, Cohort 2, Cohort 3) and two samples were collected, one at pre-dose and other at anytime between 1 to 5 hours post-dose on Days 99 and 113 (Cohort 4). Plasma concentrations of perampanel were measured and concentration data were summarized. Plasma concentrations of perampanel were quantified using a validated LC MS/MS analytical method. |
| Primary | Dose Normalized Average Steady-state Drug Concentration (Css,Av) of Perampanel During the Maintenance Period of the Core Phase for Non-EIAED Participants | Maintenance Period of the Core Phase- Days 99 and 113: 1-5 hours post-dose (Cohort 1, Cohort 2, Cohort 3); Days 99 and 113: Pre-dose, 1-5 hours post-dose (Cohort 4) | Dose normalized Css,Av was calculated as Css,Av/maintenance dose. Css,Av of perampanel was calculated as the ratio of area under the curve (AUC)/tau, (tau = 24 hours for perampanel) using population PK model. PK sparse sampling was performed. One sample was collected at anytime between 1 to 5 hours post-dose on Days 99 and 113 (Cohort 1, Cohort 2, Cohort 3) and two samples were collected, one at pre-dose and other at anytime between 1 to 5 hours post-dose on Days 99 and 113 (Cohort 4). Plasma concentrations of perampanel were measured and concentration data were summarized. Plasma concentrations of perampanel were quantified using a validated LC MS/MS analytical method. |
| Primary | Dose Normalized Minimum Observed Steady State Plasma Concentration (Cmin,ss) of Perampanel During the Maintenance Period of the Core Phase for Non-EIAED Participants | Maintenance Period of the Core Phase- Days 99 and 113: 1-5 hours post-dose (Cohort 1, Cohort 2, Cohort 3); Days 99 and 113: Pre-dose, 1-5 hours post-dose (Cohort 4) | Dose normalized Cmin,ss was calculated as Cmin,ss/maintenance dose, where Cmin,ss is the minimum observed steady state plasma concentration calculated using population PK model. PK sparse sampling was performed. One sample was collected at anytime between 1 to 5 hours post-dose on Days 99 and 113 (Cohort 1, Cohort 2, Cohort 3) and two samples were collected, one at pre-dose and other at anytime between 1 to 5 hours post-dose on Days 99 and 113 (Cohort 4). Plasma concentrations of perampanel were measured and concentration data were summarized. Plasma concentrations of perampanel were quantified using a validated LC MS/MS analytical method. |
| Primary | Dose Normalized AUCtau,ss of Perampanel During the Maintenance Period of the Core Phase for EIAED Participants | Maintenance Period of the Core Phase- Days 127 and 141: 1-5 hours post-dose (Cohort 1, Cohort 2, Cohort 3); Days 127 and 141: Pre-dose, 1-5 hours post-dose (Cohort 4) | Dose normalized AUCtau,ss was calculated as AUCtau,ss/maintenance dose, where AUCtau,ss is the area under the curve during a dosing interval (tau, 24 hours) at steady state calculated using population PK model. PK sparse sampling was performed. One sample was collected at anytime between 1 to 5 hours post-dose on Days 127 and 141 (Cohort 1, Cohort 2, Cohort 3) and two samples were collected, one at pre-dose and other at anytime between 1 to 5 hours post-dose on Days 127 and 141 (Cohort 4). Plasma concentrations of perampanel were measured and concentration data were summarized. Plasma concentrations of perampanel were quantified using a validated LC MS/MS analytical method. |
| Primary | Dose Normalized Cmax,ss of Perampanel During the Maintenance Period of the Core Phase for EIAED Participants | Maintenance Period of the Core Phase- Days 127 and 141: 1-5 hours post-dose (Cohort 1, Cohort 2, Cohort 3); Days 127 and 141: Pre-dose, 1-5 hours post-dose (Cohort 4) | Dose normalized Cmax,ss was calculated as Cmax,ss/maintenance dose, where Cmax,ss is the maximum (peak) steady-state concentration calculated using population PK model. PK sparse sampling was performed. One sample was collected at anytime between 1 to 5 hours post-dose on Days 127 and 141 (Cohort 1, Cohort 2, Cohort 3) and two samples were collected, one at pre-dose and other at anytime between 1 to 5 hours post-dose on Days 127 and 141 (Cohort 4). Plasma concentrations of perampanel were measured and concentration data were summarized. Plasma concentrations of perampanel were quantified using a validated LC MS/MS analytical method. |
| Primary | Dose Normalized Css,Av of Perampanel During the Maintenance Period of the Core Phase for EIAED Participants | Maintenance Period of the Core Phase- Days 127 and 141: 1-5 hours post-dose (Cohort 1, Cohort 2, Cohort 3); Days 127 and 141: Pre-dose, 1-5 hours post-dose (Cohort 4) | Dose normalized Css,Av was calculated as Css,Av/maintenance dose. Css,Av of perampanel was calculated as the ratio of area under the curve (AUC)/tau, (tau = 24 hours for perampanel) using population PK model. PK sparse sampling was performed. One sample was collected at anytime between 1 to 5 hours post-dose on Days 127 and 141 (Cohort 1, Cohort 2, Cohort 3) and two samples were collected, one at pre-dose and other at anytime between 1 to 5 hours post-dose on Days 127 and 141 (Cohort 4). Plasma concentrations of perampanel were measured and concentration data were summarized. Plasma concentrations of perampanel were quantified using a validated LC MS/MS analytical method. |
| Primary | Dose Normalized Cmin,ss of Perampanel During the Maintenance Period of the Core Phase for EIAED Participants | Maintenance Period of the Core Phase- Days 127 and 141: 1-5 hours post-dose (Cohort 1, Cohort 2, Cohort 3); Days 127 and 141: Pre-dose, 1-5 hours post-dose (Cohort 4) | Dose normalized Cmin,ss was calculated as Cmin,ss/maintenance dose, where Cmin,ss is the minimum observed steady state plasma concentration calculated using population PK model. PK sparse sampling was performed. One sample was collected at anytime between 1 to 5 hours post-dose on Days 127 and 141 (Cohort 1, Cohort 2, Cohort 3) and two samples were collected, one at pre-dose and other at anytime between 1 to 5 hours post-dose on Days 127 and 141 (Cohort 4). Plasma concentrations of perampanel were measured and concentration data were summarized. Plasma concentrations of perampanel were quantified using a validated LC MS/MS analytical method. |
| Secondary | Core Phase and Extension Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Core Phase: From the first dose of study drug up to 4 weeks of follow up after the last dose in Core Phase (up to Week 24); Extension Phase: From end of Core Phase treatment up to 4 weeks of follow up after the last dose in Extension Phase (up to Week 56) | TEAE was an adverse event (AE) that emerged during treatment, having been absent at pretreatment (Baseline); or re-emerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment; or worsened in severity during treatment relative to the pretreatment state, when AE was continuous. SAE was any untoward medical occurrence that at any dose: Resulted in death; was life-threatening (meaning participant was at an immediate risk of death from AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death); Required inpatient hospitalization or prolongation of existing hospitalization; Resulted in persistent or significant disability/incapacity; Was a congenital anomaly/birth defect (in child of a participant who was exposed to the study drug). |
| Secondary | Core Phase and Extension Phase: Mean Change From Baseline in Hematology Laboratory Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, and Platelets | Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52) | Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, and platelets were expressed as 10\^9 cells per liter (/L). Change from baseline was calculated as post-baseline absolute value minus baseline value. Baseline values of Core Phase was used to calculate the change from baseline data for Extension Phase. Mean change from baseline data at end of Core Phase and at end of Extension Phase treatment for specified parameters was reported. |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Core Phase and Extension Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Core Phase: From the first dose of study drug up to 4 weeks of follow up after the last dose in Core Phase (up to Week 24); Extension Phase: From end of Core Phase treatment up to 4 weeks of follow up after the last dose in Extension Phase (up to Week 56) | The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Core Phase and Extension Phase: Mean Change From Baseline in Hematology Laboratory Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, and Platelets | Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52) | The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, overall number of participants analyzed signifies participants who were evaluable for this OM and number analyzed signifies participants who were evaluable for specified categories. | 10^9 cells/L | MEAN |
| SECONDARY | Core Phase and Extension Phase: Mean Change From Baseline in Hematology Laboratory Parameter: Erythrocytes | Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52) | The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, overall number of participants analyzed signifies participants who were evaluable for this OM. | 10^12 cells/L | MEAN |
| SECONDARY | Core Phase and Extension Phase: Mean Change From Baseline in Hematology Laboratory Parameter: Hemoglobin | Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52) | The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, overall number of participants analyzed signifies participants who were evaluable for this OM. | g/L | MEAN |
| SECONDARY | Core Phase and Extension Phase: Mean Change From Baseline in Clinical Chemistry Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase | Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52) | The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, overall number of participants analyzed signifies participants who were evaluable for this OM. | U/L | MEAN |
| SECONDARY | Core Phase and Extension Phase: Mean Change From Baseline in Clinical Chemistry Laboratory Parameter: Bilirubin | Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52) | The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, overall number of participants analyzed signifies participants who were evaluable for this OM. | mcmol/L | MEAN |
| SECONDARY | Core Phase and Extension Phase: Mean Change From Baseline in Clinical Chemistry Laboratory Parameters: Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen | Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52) | The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, overall number of participants analyzed signifies participants who were evaluable for this OM and number analyzed signifies participants who were evaluable for specified categories. | mmol/L | MEAN |
| SECONDARY | Core Phase and Extension Phase: Mean Change From Baseline in Clinical Chemistry Laboratory Parameters: Creatinine, Direct Bilirubin, Urate | Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52) | The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, overall number of participants analyzed signifies participants who were evaluable for this OM. | mcmol/L | MEAN |
| SECONDARY | Core Phase and Extension Phase: Mean Change From Baseline in Clinical Chemistry Laboratory Parameters: Albumin, Globulin, Protein | Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52) | The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, overall number of participants analyzed signifies participants who were evaluable for this OM. | g/L | MEAN |
| SECONDARY | Core Phase and Extension Phase: Mean Change From Baseline in Vital Sign Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52) | The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, overall number of participants analyzed signifies participants who were evaluable for this OM. | mmHg | MEAN |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group434
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Core Phase and Extension Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel | Participants with TEAEs | 3 | Participants | |
| Core Phase and Extension Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel | Participants with TEAEs | 5 | Participants | |
| Core Phase and Extension Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Core Phase, Cohort 3, Age >12 to <24 Months: Perampanel | Participants with TEAEs | 9 | Participants | |
| Core Phase and Extension Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Core Phase, Cohort 4, Age >=24 to <48 Months: Perampanel | Participants with TEAEs | 3 | Participants | |
| Core Phase and Extension Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Extension Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel | Participants with TEAEs | 4 | Participants | |
| Core Phase and Extension Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Extension Phase, Cohort 2, Age >6 to <=12 Months: Perampanel | Participants with TEAEs | 5 | Participants | |
| Core Phase and Extension Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Extension Phase, Cohort 3, Age >12 to <24 Months: Perampanel | Participants with TEAEs | 8 | Participants | |
| Core Phase and Extension Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Extension Phase, Cohort 4, Age >=24 to <48 Months: Perampanel | Participants with TEAEs | 1 | Participants | |
| Core Phase and Extension Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel | Participants with SAEs | 2 | Participants | |
| Core Phase and Extension Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel | Participants with SAEs | 1 | Participants |
1 to 10 of 434Source ClinicalTrials.gov
See all 434 results by groupParticipant flow32
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Core Phase (Up to 20 Weeks) | STARTED | Cohort 1, Age >=1 to <=6 Months: Perampanel | 4 | |
| Core Phase (Up to 20 Weeks) | STARTED | Cohort 2, Age >6 to <=12 Months: Perampanel | 5 | |
| Core Phase (Up to 20 Weeks) | STARTED | Cohort 3, Age >12 to <24 Months: Perampanel | 9 | |
| Core Phase (Up to 20 Weeks) | STARTED | Cohort 4, Age >=24 to <48 Months: Perampanel | 3 | |
| Core Phase (Up to 20 Weeks) | Participants Who Did Not Take EIAED | Cohort 1, Age >=1 to <=6 Months: Perampanel | 4 | |
| Core Phase (Up to 20 Weeks) | Participants Who Did Not Take EIAED | Cohort 2, Age >6 to <=12 Months: Perampanel | 3 | |
| Core Phase (Up to 20 Weeks) | Participants Who Did Not Take EIAED | Cohort 3, Age >12 to <24 Months: Perampanel | 5 | |
| Core Phase (Up to 20 Weeks) | Participants Who Did Not Take EIAED | Cohort 4, Age >=24 to <48 Months: Perampanel | 1 | |
| Core Phase (Up to 20 Weeks) | Participants Who Took EIAED | Cohort 1, Age >=1 to <=6 Months: Perampanel | 0 | |
| Core Phase (Up to 20 Weeks) | Participants Who Took EIAED | Cohort 2, Age >6 to <=12 Months: Perampanel | 2 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 participant flowAdverse events568
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 | Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel | 0 | 4 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel | 1 | 5 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Core Phase, Cohort 3, Age >12 to <24 Months: Perampanel | 2 | 9 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Core Phase, Cohort 4, Age >=24 to <48 Months: Perampanel | 1 | 3 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Extension Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel | 0 | 4 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Extension Phase, Cohort 2, Age >6 to <=12 Months: Perampanel | 1 | 5 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Extension Phase, Cohort 3, Age >12 to <24 Months: Perampanel | 2 | 8 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Extension Phase, Cohort 4, Age >=24 to <48 Months: Perampanel | 1 | 1 | 1 |
| other | Vomiting | Gastrointestinal disorders | Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel | 0 | 4 | 0 |
| other | Vomiting | Gastrointestinal disorders | Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel | 1 | 5 | 1 |
1 to 10 of 568Source ClinicalTrials.gov
See all 568 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel | 0 | 4 |
| Total, all-cause mortality | Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel | 0 | 5 |
| Total, all-cause mortality | Core Phase, Cohort 3, Age >12 to <24 Months: Perampanel | 0 | 9 |
| Total, all-cause mortality | Core Phase, Cohort 4, Age >=24 to <48 Months: Perampanel | 0 | 3 |
| Total, all-cause mortality | Extension Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel | 0 | 4 |
| Total, all-cause mortality | Extension Phase, Cohort 2, Age >6 to <=12 Months: Perampanel | 0 | 5 |
| Total, all-cause mortality | Extension Phase, Cohort 3, Age >12 to <24 Months: Perampanel | 0 | 8 |
| Total, all-cause mortality | Extension Phase, Cohort 4, Age >=24 to <48 Months: Perampanel | 0 | 1 |
| Total, other adverse events | Core Phase, Cohort 1, Age >=1 to <=6 Months: Perampanel | 2 | 4 |
| Total, other adverse events | Core Phase, Cohort 2, Age >6 to <=12 Months: Perampanel | 5 | 5 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 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/NCT02914314
GET https://conductscience.org/api/trials/v1/NCT02914314/registered?page=2