At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 180 enrolled
Drug / intervention
Perampaneldrug
Likely dose
Not stated in record
Key inclusion· 6
- ✓Age 4 to <12 years at informed consent/assent
- ✓Diagnosed with partial-onset seizures (with or without secondary generalization) or primary generalized tonic-clonic seizures, established ≥6 months prior by clinical history and EEG
- ✓≥1 seizure (simple motor, complex partial-onset, or complex with secondary generalization) in 12 weeks before Visit 2 (4 weeks in Japan only)
- ✓Minimum weight 16 kg (35 lb)
Key exclusion· 19
- ✕Pseudo-seizures (psychogenic nonepileptic seizures) within ~5 years before Visit 1
- ✕Status epilepticus requiring hospitalization in 6 months before Visit 1
- ✕Unstable psychiatric diagnosis with significant suicide risk, suicidal behavior/ideation, current psychotic disorder, or acute mania
- ✕Suicidal ideation with intent ± plan in 6 months before Visit 2 (C-SSRS questions 4-5 positive) in participants aged ≥6 years
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Multicenter Study With an Extension Phase to Evaluate the Safety, Tolerability, and Exposure-Efficacy Relationship of Perampanel Oral Suspension When Administered as an Adjunctive Therapy in Pediatric Subjects (Age 4 to Less Than 12 Years) With Inadequately Controlled Partial-Onset Seizures or Primary Generalized Tonic Clonic Seizures
In Brief
A Phase 3 clinical trial evaluating Perampanel for Partial-Onset or Primary Generalized Tonic-Clonic Seizures. Completed, enrolled 180 participants across 91 sites in 12 countries.
Detailed Summary
This is an open-label, multicenter study with an Extension Phase to evaluate the safety and tolerability of perampanel oral suspension when administered as an adjunctive therapy in children (ages 4 to less than \[\<\] 12 years) with inadequately controlled partial onset seizures (POS) or primary generalized tonic clonic (PGTC) seizures.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Canada, Czechia, France, Hungary, Italy, Japan, Latvia, Poland, South Korea, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 2016
Enrollment StartNov 2016
Primary CompletionFeb 2019
Study CompletionDec 2021
TodayJul 2026
First PostedJul 29, 2016
Enrollment StartNov 16, 2016
Primary CompletionFeb 5, 2019
Study CompletionDec 6, 2021
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 9.9 years ago
Interventions
Perampaneldrug
E2007