XYREM EU-RMP: Effectiveness Assessment Protocol of Educational Materials

Study identification

• EU PAS number:
  EUPAS15024
• Study ID:
  29341
• Official title and acronym:
  XYREM EU-RMP: Effectiveness Assessment Protocol of Educational Materials
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Germany

  Italy

  Spain

  Sweden

  United Kingdom
• Study description:
  The overall research question is to evaluate the effectiveness of the educational material risk minimization measures (RMMs) being implemented in the EU to mitigate the important identified risks of respiratory and central nervous system (CNS) depression, depression and suicidality, abuse and misuse of XYREM, diversion and criminal use, overdose, dependency/withdrawal, and interactions of XYREM with alcohol, the important potential risks associated with sodium overload, in patients prescribed XYREM.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Actual: 07/12/2015

Study start date

Actual: 01/01/2016

Data analysis start date

Planned: 29/12/2017

Date of final study report

Planned: 14/04/2019

Actual: 09/04/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

UCB BioPharma SPRL

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)