The Risk of Dystonia among Children and Adolescents Treated with Atomoxetine within the Truven MarketScan Database (B4Z-MC-B031)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/23712
• EU PAS number:
  EUPAS11221
• Study ID:
  23712
• Official title and acronym:
  The Risk of Dystonia among Children and Adolescents Treated with Atomoxetine within the Truven MarketScan Database (B4Z-MC-B031)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The proposed study is a retrospective cohort study using secondary data from the Truven Health Analytics MarketScan database. The primary objective is to evaluate the incidence and risk of dystonia among atomoxetine treated patients between 6 to 17 years of age relative to a propensity score matched cohort of stimulant treated patients. This objective will be attained by estimating the hazard ratio (HR) from a Cox proportional hazards regression model.
• Study status:
  Finalised

Research institutions and networks

Institutions

Eli Lilly and Company

Study timelines

Date when funding contract was signed

Actual: 06/01/2016

Study start date

Actual: 11/01/2016

Date of final study report

Planned: 30/09/2016

Actual: 06/03/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Study protocol

Initial protocol

B031 PASS(1.0)

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only