Study type

Study type

Non-interventional study

Scope of the study

Drug utilisation
Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

VALPROIC ACID
VALPROMIDE

Anatomical Therapeutic Chemical (ATC) code

(N03AG01) valproic acid
valproic acid
(N03AG02) valpromide
valpromide

Medical condition to be studied

Epilepsy
Bipolar disorder
Pregnancy
Population studied

Age groups

Adolescents (12 to < 18 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)

Special population of interest

Pregnant women

Estimated number of subjects

2304
Study design details

Main study objective

The primary objective is mentioned in study summary due to lack of space here. The aim of this study is to describe the prescribing practices before and after the dissemination of the new risk minimization measures (RMMs) (planned over Q2 2018 - Q4 2018, depending on approval by National Competent Authorities) in Europe and to assess the effectiveness of these measures.

Data analysis plan

Given the study objectives the analyses will be mainly descriptive and will be conducted by country, database, and study time periods (both pre-implementation periods and post-implementation period). Categorical variables will be presented as counts (n), proportions (%) with confidence interval (CI) where relevant. Continuous variables will be presented as means with standard deviation (SD) and as medians with interquartile range (IQR), where appropriate. The main analyses will compare the prescribing practices in WCBP receiving valproate during the pre- and post-implementation periods with respect to key elements of the PPP and will compare the incidence of valproate exposed pregnancies, and characteristics of exposed pregnancies during the same periods to meet the primary study objective.