Trial · NCT01527006
Pharmacokinetics, Efficacy, and Safety of Perampanel Oral Suspension on Seizure Frequency in Pediatric Subjects Maintained on One to Three Stable Antiepileptic Drugs
NCT01527006, Phase 2, Completed, Eisai Inc.; results first posted 2015-08-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pharmacokinetics, Efficacy, and Safety of Perampanel Oral Suspension on Seizure Frequency in Pediatric Subjects Maintained on One to Three Stable Antiepileptic Drugs. Trials, record NCT01527006. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01527006
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacokinetics, Efficacy, and Safety of Perampanel Oral Suspension on Seizure Frequency in Pediatric Subjects Maintained on One to Three Stable Antiepileptic Drugs
- NCT number
- NCT01527006
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 63 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Central Nervous System
- Interventions
- perampanel
- First posted
- 2012-02-06
- Last updated
- 2016-07-12
- Results first posted
- 2015-08-28
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Apparent Clearance (CL/F) of Perampanel [Core Study] | From Day 8 up to Day 78 | CL/F was defined as the volume of plasma cleared of the drug per unit time. Blood samples were collected at day 8, Day 36, Day 64 , and Day 78. The CL/F values were calculated for each visit and averaged to derive the total CL/F value per arm. Data was analyzed for 2 categories: CYP3A4/5 inducers (carbamazepine, oxcarbazepine and phenytoin) and non-inducers. Data is presented as mean Liter per hour +/-standard deviation. |
| Primary | Steady-state Average Concentration (C av,ss) of Perampanel [Core Study] | From Day 8 up to Day 78 | C av,ss was calculated as 'Dose (mg)/Dosing Interval (24 h)/(CL/F \[L/h\]) x 1000'. C av,ss during a dosing interval was dose-normalized to 0.12 mg/kg in participants aged ≥ 2 to less than 12 years (intended to correspond to 8 mg/70 kg in adults/adolescents). Blood samples were collected at day 8, Day 36, Day 64 , and Day 78. C av,ss values were calculated for each visit and averaged to derive the total C av,ss value per arm. Data was analysed for 2 categories: CYP3A4/5 inducers (carbamazepine, oxcarbazepine and phenytoin) and non-inducers. Data is presented as mean Liter per hour +/- standard deviation. |
| Secondary | Percent Change From Baseline in Seizure Frequency Per 28 Days in Treatment Phase [Core Study] | Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Week 0 to Week 15 | Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated the number of seizures over the time interval multiplied by 28 and divided by the number of days in the interval. The percent change in 28-day seizure frequency from baseline was assessed for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures. The data is presented as mean percent change +/- standard deviation. |
| Secondary | 50% Responder Rate During the Maintenance Period-LOCF [Core Study] | Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Week 9 to 11 | Responder rate was defined as the proportion of participants with a 50% decrease in 28-day seizure frequency during the Maintenance Period compared to Baseline \[2 weeks Pretreatment Phase (Visit 1) plus 4 Weeks Prior to Pretreatment Phase\] for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures. The data is presented as percent responders. LOCF = Last Observation Carried Forward. |
| Secondary | Seizure-free Rate During the Maintenance Period [Core Study] | Week 9 to Week 11 | Seizure-free rate, defined as the percentage of participants who were seizure-free during the Maintenance Period. SG = Secondary Generalization. |
| Secondary | The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study] | Week 0 (Baseline), Week 11 or EOT | The Clinical Global Impression (CGI) evaluated perceived seizure frequency and severity, the occurrence of AEs, and overall functional status of the participant. The investigator performed the Clinical Global Impression of Severity for all participants at Baseline (Week 0). The evaluation used a 7-point scale where 1=normal, not at all ill and 7=extremely ill. The investigator performed the Clinical Global Impression of Change for all participants at the EOT (the duration after the day of first study drug dose up to 7 days after the last Core Phase drug dose, inclusive). The evaluation used a 7-point scale where 1=very much improved and 7=very much worse. This tool was used to assess the participant's status over the 4-week period prior to its completion compared to Baseline (Week 0). |
| Secondary | Number of Participants With Treatment Emergent Non-Serious Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel | For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase | An AE was defined as any untoward medical occurrence in a participant administered with the study drug. A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the 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, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug up to 30 days after the final dose of study drug) were assessed. The details of the adverse events are presented in the safety section of the results. |
| Secondary | Palatability Questionnaire Assessment - How Does This Medicine Taste [Core Study] | Week 5 or at the time of early discontinuation | The Palatability Questionnaire was answered directly by participants in Cohort ( ≥ 7 to ≤ 12 years) and indirectly by participants in Cohort ( ≥ 2 to ≤ 7 years) via their parents/caregivers. Participants selected their response from one of the five options (very good, good, not good-not bad, bad, very bad). |
| Secondary | Palatability Questionnaire Assessment - How Does This Medicine Smell [Core Study] | Week 5 or at the time of early discontinuation | The Palatability Questionnaire was answered directly by participants in Cohort ( ≥ 7 to ≤ 12 years) and indirectly by participants in Cohort ( ≥ 2 to ≤ 7 years) via their parents/caregivers. Participants selected their response from one of the five options (very good, good, not good-not bad, bad, very bad). |
| Secondary | Palatability Questionnaire Assessment - Based on Its Taste, Smell, and How it Felt in the Mouth, How Easy or Difficult Was it for You / Your Child to Take This Medicine Every Day [Core Study] | Week 5 or at the time of early discontinuation | The Palatability Questionnaire was answered directly by participants in Cohort ( ≥ 7 to ≤ 12 years) and indirectly by participants in Cohort ( ≥ 2 to ≤ 7 years) via their parents/caregivers. Participants selected their response from one of the five options (very easy, easy, neither easy or difficult, difficult and very difficult). |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Percent Change From Baseline in Seizure Frequency Per 28 Days in Treatment Phase [Core Study] | Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Week 0 to Week 15 | The full analysis set, defined as participants who received study drug, had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to the Pretreatment Phase (Visit 1), and during the Treatment Phase of the Core Study. | Percent change | MEDIAN |
| PRIMARY | Apparent Clearance (CL/F) of Perampanel [Core Study] | From Day 8 up to Day 78 | The pharmacokinetic (PK) analysis set, defined as participants with at least 1 pharmacokinetic assessment of perampanel with a documented dosing history. | Liter per hour | MEAN |
| SECONDARY | 50% Responder Rate During the Maintenance Period-LOCF [Core Study] | Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Week 9 to 11 | The full analysis set, defined as participants who received study drug, had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to the Pretreatment Phase (Visit 1), and during the Treatment Phase of the Core Study. | Percent responders | NUMBER |
| SECONDARY | Seizure-free Rate During the Maintenance Period [Core Study] | Week 9 to Week 11 | The full analysis set, defined as participants who received study drug, had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to the Pretreatment Phase (Visit 1), and during the Treatment Phase of the Core Study. | Percentage of participants | NUMBER |
| SECONDARY | The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study] | Week 0 (Baseline), Week 11 or EOT | The Full Analysis Set, defined as participants who received study drug, had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to the Pretreatment Phase (Visit 1), and during the Treatment Phase of the Core Study. | Participants | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Non-Serious Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel | For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase | The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase. | Participants | NUMBER |
| SECONDARY | Palatability Questionnaire Assessment - How Does This Medicine Taste [Core Study] | Week 5 or at the time of early discontinuation | The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment. | Participants | NUMBER |
| SECONDARY | Palatability Questionnaire Assessment - How Does This Medicine Smell [Core Study] | Week 5 or at the time of early discontinuation | The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment. | Participants | NUMBER |
| SECONDARY | Palatability Questionnaire Assessment - Based on Its Taste, Smell, and How it Felt in the Mouth, How Easy or Difficult Was it for You / Your Child to Take This Medicine Every Day [Core Study] | Week 5 or at the time of early discontinuation | The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment. | Participants | NUMBER |
| PRIMARY | Steady-state Average Concentration (C av,ss) of Perampanel [Core Study] | From Day 8 up to Day 78 | The PK analysis set, defined as participants with at least 1 pharmacokinetic assessment of perampanel with a documented dosing history. | ng/mL | MEAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group290
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Seizure Frequency Per 28 Days in Treatment Phase [Core Study] | Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Overall seizures | -43.6 | Full Range -100 to 95.4 | Percent change |
| Percent Change From Baseline in Seizure Frequency Per 28 Days in Treatment Phase [Core Study] | Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Overall seizures | -33.9 | Full Range -100 to 1038.9 | Percent change |
| Percent Change From Baseline in Seizure Frequency Per 28 Days in Treatment Phase [Core Study] | Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Overall partial seizures | -82.5 | Full Range -100 to 95.4 | Percent change |
| Percent Change From Baseline in Seizure Frequency Per 28 Days in Treatment Phase [Core Study] | Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Overall partial seizures | -46.8 | Full Range -100 to 1722.2 | Percent change |
| Percent Change From Baseline in Seizure Frequency Per 28 Days in Treatment Phase [Core Study] | Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Overall generalized seizures | -53.1 | Full Range -100 to 188.7 | Percent change |
| Percent Change From Baseline in Seizure Frequency Per 28 Days in Treatment Phase [Core Study] | Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Overall generalized seizures | 305.4 | Full Range -62.9 to 1277.3 | Percent change |
| Percent Change From Baseline in Seizure Frequency Per 28 Days in Treatment Phase [Core Study] | Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Unclassified Seizures | -73.7 | Full Range -100 to 217.3 | Percent change |
| Percent Change From Baseline in Seizure Frequency Per 28 Days in Treatment Phase [Core Study] | Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Unclassified Seizures | -67.3 | Full Range -100 to -34.6 | Percent change |
| Apparent Clearance (CL/F) of Perampanel [Core Study] | Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | Non-Inducers (N=14, 12) | 0.732 | Standard Deviation 0.374 | Liter per hour |
| Apparent Clearance (CL/F) of Perampanel [Core Study] | Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | Non-Inducers (N=14, 12) | 0.956 | Standard Deviation 0.4 | Liter per hour |
1 to 10 of 290Source ClinicalTrials.gov
See all 290 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Core Study | STARTED | Cohort ( ≥ 2 to < 7 Years of Age) | 22 | |
| Core Study | STARTED | Cohort ( ≥ 7 to < 12 Years of Age) | 28 | |
| Core Study | COMPLETED | Cohort ( ≥ 2 to < 7 Years of Age) | 20 | |
| Core Study | COMPLETED | Cohort ( ≥ 7 to < 12 Years of Age) | 22 | |
| Core Study | NOT COMPLETED | Cohort ( ≥ 2 to < 7 Years of Age) | 2 | |
| Core Study | NOT COMPLETED | Cohort ( ≥ 7 to < 12 Years of Age) | 6 | |
| Extension Phase | STARTED | Cohort ( ≥ 2 to < 7 Years of Age) | 19 | |
| Extension Phase | STARTED | Cohort ( ≥ 7 to < 12 Years of Age) | 22 | |
| Extension Phase | COMPLETED | Cohort ( ≥ 2 to < 7 Years of Age) | 13 | |
| Extension Phase | COMPLETED | Cohort ( ≥ 7 to < 12 Years of Age) | 14 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events572
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 | Abdominal Pain Upper | Gastrointestinal disorders | Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | 0 | 22 | |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | 4 | 28 | |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase | 0 | 19 | |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase | 5 | 22 | |
| other | Vomiting | Gastrointestinal disorders | Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | 3 | 22 | |
| other | Vomiting | Gastrointestinal disorders | Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | 5 | 28 | |
| other | Vomiting | Gastrointestinal disorders | Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase | 4 | 19 | |
| other | Vomiting | Gastrointestinal disorders | Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase | 6 | 22 | |
| other | Fatigue | General disorders | Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | 1 | 22 | |
| other | Fatigue | General disorders | Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | 8 | 28 |
1 to 10 of 572Source ClinicalTrials.gov
See all 572 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | ||
| Total, all-cause mortality | Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | ||
| Total, all-cause mortality | Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase | ||
| Total, all-cause mortality | Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase | ||
| Total, other adverse events | Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | 22 | 22 |
| Total, other adverse events | Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | 25 | 28 |
| Total, other adverse events | Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase | 19 | 19 |
| Total, other adverse events | Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase | 22 | 22 |
| Total, serious adverse events | Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | 3 | 22 |
| Total, serious adverse events | Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | 5 | 28 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30739576 | DERIVED |
Source PubMed
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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Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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