Study identification

PURI

https://redirect.ema.europa.eu/resource/36996

EU PAS number

EUPAS21056

Study ID

36996

Official title and acronym

Extrapyramidal symptoms in patients treated with Abilify Maintena®: Cohort study with a 2-year follow-up using European automated healthcare databases

DARWIN EU® study

No

Study countries

Germany
Italy
Sweden

Study description

This post-authorisation safety study (PASS) will be conducted using longitudinal automatic healthcare databases. It uses a non-comparative historical cohort design to further assess the risk of EPS-related events linked to the use of Abilify Maintena®, in routine clinical practice.All new users of Abilify Maintena® (incident users) between country-specific market entry date and the end of the inclusion period will be included in the analysis. The first observed prescription of Abilify Maintena® for a patient after market entry is called the index prescription, and the index date relates to the date of this index prescription. The crude incidence of EPS-related events and incidence per patient-month will be estimated, using the number of exposed patients with at least one EPS-related event (during treatment exposure period). In addition, an analysis on time to EPS onset will be performed using Kaplan-Meier estimator of survival function and Cox proportional hazards regression model. In addition, a Cox proportional hazards regression model will be performed to measure the effect of known risk factors described in Section 9.3.3 Other Variables on the occurrence of EPS-related event in this population.

Study status

Ongoing
Research institution and networks

Institutions

H. Lundbeck
First published:
01/02/2024
Institution
RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
19/02/2024
Institution
Not-for-profitENCePP partner

Contact details

Non-interventional Research Manager H. Lundbeck A/S

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Start date of data analysis

Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

H. Lundbeck A/S
Study protocol
Initial protocol

15893N_Abstract_EUPAS_register_FINAL

English (137.97 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 3 (required)