A global postmarketing observational safety study to evaluate the safety and tolerability of Fycompa (perampanel) as add-on therapy in epilepsy patients aged > 12 years

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  FYCOMPA
• Medical condition to be studied:
  Epilepsy

Population studied

• Short description of the study population:
  Subjects who did not meet all of the inclusion criteria or who met any of the exclusion criteria were not eligible to receive treatment.; Inclusion Criteria; 1. Male or female subjects aged ≥12 years (or as regionally appropriate) at the time of informed consent; 2. Subjects prescribed perampanel for the adjunctive treatment of epilepsy within 7 days of the Screening Visit; 3. Subjects who provided informed consent; Exclusion Criteria; 1. Participation in another study involving administration of an investigational drug or device whilst participating in this observational study; 2. Prior participation in a perampanel clinical study; 3. Hypersensitivity to perampanel
• 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:
  Epilepsy patients
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  Incidence of TEAEs of interest defined as: dizziness, blurred vision, somnolence, aggression, balance disorders, ataxia, falls, unintended pregnancy, weight gain, suicidality, drug abuse, misuse, dependence, withdrawal, off-label use, skin photosensitivity, unintended pregnancywhile taking levonorgestrel-containing contraceptives, and outcomes associated with any suspected drug-drug interaction.
• Data analysis plan:
  The incidence of TEAEs will be summarized. The incidence of TEAEs of interest, as defined in the primary and secondary variables will be summarized or listed as appropriate. The incidence of SAEs, TEAEs leading to discontinuation, TEAEs by severity, and TEAEs by relationship to treatment will be summarized.HADS scores will be summarized.Change from baseline in weight and the proportion of patients who have at least a 5% and 10% increase in weight from baseline to EOS will be summarized.Duration of treatment and perampanel dose information will be summarized