Etude d’impact de la communication menée auprès des médecins prescripteurs d’Epitomax® et ses génériques en France

Study type

• Study topic:
  Human medicinal product
• Study type:
  Not applicable
• If ‘Not applicable’, further details on the study type:
  Impact assessment of the communication carried out with Epitomax prescribing physicians® and its generics in France, Cross-sectional
• If ‘other’, further details on the scope of the study:
  Impact assessment of the communication carried out with Epitomax prescribing physicians® and its generics in France

Study drug and medical condition

• Medicinal product name, other:
  TOPIRAMATE
• Study drug International non-proprietary name (INN) or common name:
  TOPIRAMATE
• Anatomical Therapeutic Chemical (ATC) code:
  (N03AX11) topiramate

  topiramate

Population studied

• Short description of the study population:
  Epitomax prescribing physicians®
• 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)
• Estimated number of subjects:
  4678

Study design details

• Main study objective:
  Comparisons of topiramate prescriptions before and after DHCP letter sent to prescribers. Assessments of indication, patients characteristics, treatment details
• Outcomes:
  the impact of the communication plan carried out with physicians in private practice (generalists, psychiatrists, neurologists and paediatricians) involved in the prescription of topiramate-based specialties on the proportion of off-label prescriptions, Describe the situation before & after the communication plan including:how to use topiramate in real conditions of use: profile of patients treated, prescribing methods(dose & duration), demographic characteristics, indication that motivated the prescription of treatment, profile of the prescribers of topiramate-based medicinal products including all the originally-prescribing specialties
• Data analysis plan:
  Cross-sectional, retrospective, observational study of the before/after type conducted using data obtained from panels of prescribers practicing in a non-hospital setting and representative of the national activity.