Post-authorisation Safety Study to Evaluate the Long-term Safety of Dexamfetamine (Amfexa) (PASS for dexamfetamine)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/43105
• EU PAS number:
  EUPAS7782
• Study ID:
  43105
• Official title and acronym:
  Post-authorisation Safety Study to Evaluate the Long-term Safety of Dexamfetamine (Amfexa) (PASS for dexamfetamine)
• DARWIN EU® study:
  No
• Study countries:
  Germany

  United Kingdom

  United States
• Study description:
  A PASS to further analyse the safety of dexamfetamine specifically targeting assessment of: • cardiovascular events • growth relating to sexual maturation • psychiatric disorders • sexual maturity disorders
• Study status:
  Finalised

Research institutions and networks

Institutions

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 29/07/2016

Actual: 22/06/2016

Study start date

Planned: 01/09/2016

Actual: 01/01/2015

Data analysis start date

Planned: 01/01/2017

Actual: 01/01/2017

Date of interim report, if expected

Planned: 01/01/2017

Actual: 27/01/2017

Date of final study report

Planned: 31/12/2020

Actual: 17/12/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Medice

Study protocol

Initial protocol

Medice dexamfetamine PASS protocol v6 0 01-06-2016

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)