WEUKBRE5744: European Survey of Patient and Prescriber Understanding of Risks Associated with TROBALT™ (116771)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/42075
• EU PAS number:
  EUPAS4126
• Study ID:
  42075
• Official title and acronym:
  WEUKBRE5744: European Survey of Patient and Prescriber Understanding of Risks Associated with TROBALT™ (116771)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Germany

  Norway

  Slovakia

  Spain

  Sweden

  Switzerland

  United Kingdom
• Study description:
  This is a cross-sectional survey of prescribers and patients on the effectiveness of the physician guide and the patient information leaflet on physician and patient understanding of the significant risks of TROBALT (retigabine). This forms part of the European Risk Management Plan (RMP) requirements.
• Study status:
  Finalised

Research institution and networks

Institutions

United BioSource Corporation (UBC)

Switzerland

Study timelines

Date when funding contract was signed

Actual: 18/09/2012

Study start date

Actual: 18/09/2012

Date of final study report

Planned: 27/09/2014

Actual: 31/01/2014

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Study protocol

Initial protocol

Redacted 1166771_Protocol_Trobalt_EU_Survey_Amendment 11-Sep-2012_FINAL

Updated protocol

WEUKBRE5744-protocol-redact

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)