A European Study of the Effectiveness of Risk Minimisation Measures for Fenfluramine in Dravet Syndrome (TAPESTRY eRMM)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48742
• EU PAS number:
  EUPAS48741
• Study ID:
  48742
• Official title and acronym:
  A European Study of the Effectiveness of Risk Minimisation Measures for Fenfluramine in Dravet Syndrome (TAPESTRY eRMM)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Denmark

  France

  Germany

  Italy

  Spain

  United Kingdom
• Study description:
  This observational study will assess the effect of additional risk minimisation measures by describing the awareness, knowledge, and compliance of fenfluramine prescribers to the physician-specific educational material, as well as the distribution of the patient/carer educational material by the physicians.
• Study status:
  Ongoing

Study timelines

Date when funding contract was signed

Actual: 27/06/2022

Study start date

Actual: 30/08/2022

Date of final study report

Planned: 11/08/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Zogenix International Ltd., UCB BioSciences Inc.

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)

Other study registration identification numbers and links

EP0220,ZX008-2104