An observational study in Idiopathic Generalized Epilepsy, Partial Onset Seizures and Generalised Tonic-Clonic Seizures, sponsored by Eisai Limited. Completed at 36 sites in 7 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2023-02-09.
Sponsored by Eisai Limited · Observational
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.
Approximately 300 participants with diagnosis of epilepsy (POS with or without SG or PGTCS associated with IGE)
Exclusion Criteria:
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
Participants with a diagnosis of epilepsy (POS with or without SG or PGTCS associated with IGE) will initiate treatment with perampanel as first adjunctive treatment as per the clinical judgment of the treating physician as part of routine clinical care. All participants will be observed prospectively for up to 12 months after initiation of perampanel treatment.
Drug: Perampanel
Perampanel oral tablets or oral suspension.
Also known as: Fycompa
Retention Rate at Month 12
Retention rate at 12 months is defined as the percentage of participants remaining on perampanel at 12 months.
Time frame: Month 12
Retention Rate at Month 6
Retention rate at 6 months is defined as the percentage of participants remaining on perampanel at 6 months.
Time frame: Month 6
Pragmatic Seizure-free Rate at 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).
Time frame: Months 6 and 12
Completer Seizure-free Rate at 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.
Time frame: Months 6 and 12
Median Percent Change From Baseline in Seizure Frequency at 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).
Time frame: Months 6 and 12
50 Percent (%) Responder Rate at 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.
Time frame: Months 6 and 12
Seizure Worsening Rate at 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.
Time frame: Months 6 and 12
Last Dose of Perampanel at Months 6 and 12
Time frame: Months 6 and 12
Percentage of Participants by Perampanel Dose Titration Speed
Time frame: Up to Month 12
Duration of Treatment on Perampanel
Time frame: 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
Time frame: Up to Month 12
Plan to share: Yes — Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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Eisai Limited