Surveys among Health Care Professionals and Patients to assess their knowledge and behaviour with respect to the new (2018) Risk Minimization Measures for valproate use in Europe. (VALNAC09348)

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

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

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Multinational survey

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N03AG01) valproic acid

  valproic acid

  (N03AG02) valpromide

  valpromide
• Medical condition to be studied:
  Epilepsy

  Bipolar disorder

  Pregnancy

Population studied

• Short description of the study population:
  The study focused on female patients of childbearing age received treatment with valproate-containing medicines.; Inclusion criteria: ; Prescribers of valproate: GPs, neurologists (including pediatric neurologists), paediatricians and psychiatrists who prescribed valproate containing medicines to female patients of childbearing potential in the last 6 months.; Gynaecologists: Gynaecologists who have had a consultation with at least one female patient of childbearing potential treated with valproate containing medicines in the last 6 months.; Pharmacists: Pharmacists who have dispensed valproate containing medicines to female patients of childbearing potential in the last 6 months. The survey will enrol only those pharmacists who have dispensed the drug in a pre-specified period of last six months.; ; Patients; • Female patients of childbearing age (i.e., 13 to 49 years of age) and being treated with valproate-containing medicines at the time of the survey; • Who consent to participate in this self-administered survey (for patients between 13 to 17 years of age, the survey shall be filled out by their parent, guardian or caregiver); ; Exclusion criteria: ; • HCPs or patients who may have conflicts of interest with the survey (i.e. patients employed by regulatory bodies or pharmaceutical companies).; • HCPs or patients (with a relative) involved in valproate-related lawsuits or associations for victims of valproate syndrome.
• 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:
  Pregnant women
• Estimated number of subjects:
  2695

Study design details

• Main study objective:
  To evaluate awareness, knowledge and behaviour of Health Care Professionals and Patients with respect to the new (2018) Risk Minimization Measures for valproate use in 6 European countries.
• Data analysis plan:
  All the analyses will be descriptive. Continuous variables will be described by their mean, standard deviation, and median, first quantile (Q1), third quantile (Q3), minimum and maximum. Categorical variables will be described as total number and relative percentage per category. Analysis for the survey will be performed for patients and HCPs (prescribers, gynaecologists and pharmacists) separately for the endpoints described below, and will include the total number of patients and HCPs with valid responses to all relevant questions and the percentage of patients and HCPs with a positive response for the questions. The statistical results of the included European countries will be presented overall and then at country level. The analysis of the Patients’ and HCPs’ surveys will then be broken down by subpopulation of interest, i.e. according to therapeutic indication (epilepsy / bipolar disorders).

Documents

Study results

epi-valproate-VALNAC09348-PASS-Surveys-Abstract-Final-Study-Report-v1.0-sept2023