Study identification

PURI

https://redirect.ema.europa.eu/resource/27280

EU PAS number

EUPAS7537

Study ID

27280

Official title and acronym

A drug utilisation study in patients treated with EXELON®/PROMETAX® (rivastigmine) transdermal patch

DARWIN EU® study

No

Study countries

Germany
Greece
Portugal
United Kingdom

Study description

Exelon/Prometax is indicated for mild to moderately severe Alzheimer’s dementia. Postmarketing adverse event reports have documented instances of medication misuse and medication error. EMA/CHMP requested development of educational materials to help minimise multiple patch use. The aim of this DUS is to assess the extent of inappropriate use of Exelon/Prometax patches following introduction of this new educational materials and to assess titration patterns. This proposed DUS is a prospective, non-interventional, multinational, multicentre, cohort field post-authorization safety study (PASS) of physician prescribing patterns and patient use of Exelon/Prometax patches. The study will be implemented in EU, e.g., Germany, Greece, Portugal, United Kingdom. The total study population is ~800 patients. Total duration of patient data collection will be up to 11 months for each patient.

Study status

Finalised
Research institution and networks

Institutions

Multiple centres
Multiple centres: 80 centres are involved in the study

Contact details

Novartis Clinical Disclosure Officer

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

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

More details on funding

Novartis
Study protocol
Initial protocol

cena713d2409-redacted protocol

English (756.01 KB - PDF)View document
Updated protocol

ena713d2409-v02--protocol amendment redacted

English (1.06 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)