Study identification

PURI

https://redirect.ema.europa.eu/resource/32511

EU PAS number

EUPAS28367

Study ID

32511

Official title and acronym

A Multicenter, Multinational, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra® When Used In Routine Medical Practice (LIBERATE)

DARWIN EU® study

No

Study countries

Argentina
Canada
Czechia
France
Germany
Ireland
Israel
Lebanon
Netherlands
Norway
Portugal
Spain
United Arab Emirates

Study description

The primary objective of the study is to collect additional safety data including the incidence rate of seizure and other specific Adverse Events (AEs) of interest from participants taking Fampyra in routine clinical practice. The secondary objectives of this study are to characterize utilization patterns of Fampyra in routine clinical practice, to assess the effectiveness of risk minimization measures as described in the risk management plan for Fampyra, to assess the change over time in participant self-reported evaluation of the physical and psychological impact of Multiple Sclerosis (MS) while taking Fampyra and to assess the change over time in physician assessment of walking ability in participants taking Fampyra (MS participants only).

Study status

Finalised
Research institutions and networks

Institutions

Biogen
First published:
01/02/2024
Institution
Multiple centres: 168 centres are involved in the study

Contact details

Study Director Biogen

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Biogen
Study protocol
Initial protocol

218MS401 Protocol V3 FINAL 24Feb14_Redacted

English (1.32 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

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

EU RMP category 3 (required)