A Prospective, Non-Interventional, Observational, Multicenter Study to Investigate Dosage, Effectiveness, and Safety of Perampanel When Used as First Adjunctive Therapy in the Routine Clinical Care of Subjects >=12 Years With Partial Onset Seizures With or Without Secondary Generalization or With Primary Generalized Tonic-Clonic Seizures Associated With Idiopathic Generalized Epilepsy

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Investigate Dosage
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Observational, prospective, multicenter study

Study drug and medical condition

• Name of medicine:
  FYCOMPA
• Medical condition to be studied:
  Idiopathic generalised epilepsy

  Generalised tonic-clonic seizure
• Additional medical condition(s):
  Partial Onset Seizures

Population studied

• Short description of the study population:
  The study population included subjects aged ≥12 to 65 years diagnosed with epilepsy (partial onset seizures with or without secondary generalization or with primary generalized tonic–clonic seizures associated with idiopathic generalized epilepsy) who had prescribed treatment with perampanel as first adjunctive to antiepileptic drug (AED) monotherapy as part of their routine clinical care.; Inclusion criteria:; Subjects were eligible for participation in the study if they were at least 12 years of age at screening and had a diagnosis of epilepsy and a history of POS with or without SG or PGTCS associated with IGE (according to the International League Against Epilepsy [ILAE] Classification of Epileptic Seizures, 1981 and ILAE Classification of Epileptic Syndromes, 1989) who had previously been treated with 1 or 2 AEDs as monotherapy. ; ; Exclusion criteria:; Subjects with previous or current use of perampanel at the time of screening were excluded.
• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with epilepsy
• Estimated number of subjects:
  300

Study design details

• Main study objective:
  The primary objective of this study was 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 POS with or without SG or for PGTCS associated with IGE) as first adjunctive to AED monotherapy as part of their routine clinical care.
• Outcomes:
  The primary outcome assessed the percentage of participants remaining on perampanel (retention rate) at 12 months. Assess perampanel retention rate at 6 months, pragmatic and completer seizure-free rate, seizure frequency and worsening rate, perampanel last dose and 50 percent responder rate at months 6 and 12, percentage of participants by perampanel dose titration speed, duration of treatment on perampanel, treatment-emergent adverse events (TEAEs), Serious AEs, TEAEs leading to discontinuation and severity.
• Data analysis plan:
  Data was obtained by personnel at the study site, by reviewing medical records, seizure diaries, and records of healthcare providers’ interviews with participants/caregivers at clinic visits. Data was summarized by the sponsor after study data was collected and data validation was completed. Descriptive statistics were used to calculate number and percentage for categorical variables, and mean, standard deviation, median, interquartile range, minimum and maximum, for continuous variables. Statistical analyses were performed using Statistical Analysis System software or other validated statistical software as required.