Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000494

EU PAS number

EUPAS1000000494

Study ID

1000000494

Official title and acronym

Post-Authorization Safety Study to Assess the Effectiveness of the Newly Implemented Risk Minimization Measures for Topiramate: Drug Utilization Study

DARWIN EU® study

No

Study countries

France
Germany
Spain
Sweden
United Kingdom

Study description

This is a pre-post, observational study using data derived from existing healthcare databases to answer the research question whether the newly implemented risk minimization measures for topiramate are associated with change in topiramate use and pregnancy exposure to the drug among women of childbearing potential with epilepsy or migraine diagnosis.
The study aims to describe the prevalence and the incidence of topiramate use among women of child-bearing potential (WOCBP) with epilepsy or migraine during the pre- and post-implementation period of the newly implemented risk minimization measures (RMMs).
In addition, the study aims to quantify exposure to topiramate during pregnancy among incident users of topiramate at two critical points:
(1) being pregnant at treatment initiation, and
(2) becoming pregnant during treatment.

Study status

Planned
Research institutions and networks

Institutions

Syneos Health
United Kingdom
First published:
06/03/2024
InstitutionNon-Pharmaceutical companyENCePP partner
Karolinska Institutet
Sweden
First published:
01/02/2024
InstitutionEducational Institution

Contact details

Brian Buysse

Primary lead investigator
ORCID number:
0000-0003-0026-9360
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Topiramate Safety Consortium of 30 MAHs, led by Janssen
Study protocol
Initial protocol

Protocol_abstract_Topiramate PASS_7054981_DUS.pdf

English (91.81 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 1 (imposed as condition of marketing authorisation)

Regulatory procedure number

EMEA/H/A-31/1520