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

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 institutions and networks

Institutions

H. Lundbeck

Leibniz Institute for Prevention Research and Epidemiology - BIPS

Germany

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

Global Database Studies, IQVIA

Czechia

Finland

Germany

Slovakia

Spain

Study timelines

Date when funding contract was signed

Planned: 07/07/2015

Actual: 07/07/2015

Study start date

Planned: 09/10/2017

Actual: 25/11/2017

Data analysis start date

Actual: 20/08/2018

Date of final study report

Planned: 31/03/2021

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

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)