Status: Ongoing First registered on: 26/09/2017
Last updated on: 01/09/2020
1. Study identification
EU PAS Register NumberEUPAS21056
Official titleExtrapyramidal symptoms in patients treated with Abilify Maintena®: Cohort study with a 2-year follow-up using European automated healthcare databases
Study title acronym
Study typeObservational study
Brief description of the studyThis 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.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameH. Lundbeck A/S
Centre locationValby, Denmark
Details of (Primary) lead investigator
Title Dr
Last name H. Lundbeck A/S
First name Non-interventional Research Manager
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?3

EPID Research
BIPS GmbH
RTI-HS
Countries in which this study is being conducted
International study

Germany
Italy
Sweden
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed07/07/201507/07/2015
Start date of data collection09/10/201725/11/2017
Start date of data analysis20/08/2018
Date of interim report, if expected
Date of final study report31/03/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesH. Lundbeck A/S100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name H. Lundbeck A/S
First name Non-interventional Research Manager
Address line 1Ottiliavej 9
Address line 2 
Address line 3 
CityValby 
PostcodeDK-2500 
CountryDenmark
Phone number (incl. country code)49-1784767805 
Alternative phone number 
Fax number (incl. country code) 
Email address LundbeckClinicalTrials@lundbeck.com
Public Enquiries
Title Dr 
Last name H. Lundbeck A/S 
First name Non-interventional Research Manager 
Address line 1Ottiliavej 9 
Address line 2 
Address line 3 
CityValby 
PostcodeDK-2500 
CountryDenmark 
Phone number (incl. country code)49-1784767805 
Alternative phone number 
Fax number (incl. country code) 
Email address LundbeckClinicalTrials@lundbeck.com 
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