Generalised Tonic-Clonic Seizures, Idiopathic Generalized Epilepsy, Partial Onset Seizures
Conditions
Keywords
Perampanel, Fycompa, Epilepsy, Seizures, Prospective
Brief summary
The primary purpose of this study is to assess the retention rate of perampanel as a reliable proxy for overall effectiveness and tolerability in participants aged at least 12 years who are prescribed perampanel (for partial onset seizures \[POS\] with or without secondary generalization \[SG\] or for primary generalized tonic-clonic seizures \[PGTCS\] associated with idiopathic generalized epilepsy \[IGE\] as first adjunctive to antiepileptic drug (AED) monotherapy as part of their routine clinical care.
Interventions
DRUGPerampanel
Perampanel oral tablets or oral suspension.
Sponsors
Eisai Limited
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of epilepsy 2. History of POS with or without SG or PGTCS associated with IGE 3. Documented POS with or without SG or PGTCS associated with IGE, within the past 12 months 4. Previously treated with 1 or 2 AEDs as monotherapy 5. At least 4 weeks' seizure diary data, or sufficient clinical detail to calculate baseline seizure frequency
Exclusion criteria
1. Episode(s) of status epilepticus within the past 6 months before Screening 2. Previously treated with 2 or more AEDs in combination (other than during cross-titration between AED monotherapies) 3. Previous or current use of perampanel Note: Retrospective inclusions will be allowed but only if the time between the initiation of perampanel treatment and the inclusion does not exceed 7 calendar days 4. Hypersensitivity to perampanel or any of the excipients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention Rate at Month 12 | Month 12 | Retention rate at 12 months is defined as the percentage of participants remaining on perampanel at 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pragmatic Seizure-free Rate at Months 6 and 12 | Months 6 and 12 | Pragmatic seizure-free rate is defined as the percentage of participants (based on all study participants) who are free of all seizures at 6 months (and for the previous 3 months) and at 12 months (and for the previous 6 months). |
| Completer Seizure-free Rate at Months 6 and 12 | Months 6 and 12 | Completer seizure-free rate is defined as the percentage of participants (based on a subset of study participants who remain on perampanel treatment at 6 and 12 months) who are free of all seizures at 6 months (and for the previous 3 months) and at 12 months (and for the previous 6 months), respectively. |
| Median Percent Change From Baseline in Seizure Frequency at Months 6 and 12 | Months 6 and 12 | Seizure frequency change will be measured at 6 months (averaged over the previous 3 months) and at 12 months (averaged over the previous 6 months). |
| 50 Percent (%) Responder Rate at Months 6 and 12 | Months 6 and 12 | 50% responder rate is defined as the percentage of participants with greater than or equal to (\>=) 50% reduction in seizure frequency (averaged over the 3 months before the 6-month visit, and over the 6 months before the12-month visit) relative to baseline. |
| Retention Rate at Month 6 | Month 6 | Retention rate at 6 months is defined as the percentage of participants remaining on perampanel at 6 months. |
| Last Dose of Perampanel at Months 6 and 12 | Months 6 and 12 | — |
| Percentage of Participants by Perampanel Dose Titration Speed | Up to Month 12 | — |
| Duration of Treatment on Perampanel | Up to Month 12 | — |
| Percentage of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs),Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation, and TEAEs by Severity | Up to Month 12 | — |
| Seizure Worsening Rate at Months 6 and 12 | Months 6 and 12 | Seizure worsening rate is defined as the percentage of participants with \>=10% increase in seizure frequency (averaged over the 3 months before the 6-month visit, and over the 6 months before the 12-month visit) relative to baseline. |
Countries
Denmark, France, Germany, Italy, Portugal, Russia, Spain
Outcome results
None listed