Post-marketing surveillance of long term administration of Inovelon tablets in patients with Lennox-Gastaut syndrome (INO01T)

Study type

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

  Effectiveness study (incl. comparative)

Study drug and medical condition

• Name of medicine:
  INOVELON
• Medical condition to be studied:
  Lennox-Gastaut syndrome

Population studied

• Age groups:
  • Paediatric Population (< 18 years)

    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  300

Study design details

• Main study objective:
  Post marketing surveiilance to determine the incidence of ADRs, including the incidence of skin disorders, hypersensitivity reactions and central nervous system related adverse events.The efficacy of long-term administration
• Data analysis plan:
  Descriptive analysis