Agomelatine Drug Utilisation Study in Selected European Countries: A Multinational, Observational Study to Assess Effectiveness of Risk-Minimisation Measures

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/30635
• EU PAS number:
  EUPAS17678
• Study ID:
  30635
• Official title and acronym:
  Agomelatine Drug Utilisation Study in Selected European Countries: A Multinational, Observational Study to Assess Effectiveness of Risk-Minimisation Measures
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  France

  Germany

  Spain
• Study description:
  Non-interventional, multinational Post-Autorisation Safety Study in patients initiating agomelatine treatment in routine clinical practice in Denmark, France, Germany, and Spain. The study includes a retrospective medical data abstraction to collect patient data before and after the last minimization measures in order to evaluate adherence to the liver test monitoring regimen and compliance with relevant contraindications and a cross-sectional patient survey to assess patients’ reasons for non-compliance with the liver test monitoring regimen. Medical data abstraction will collect characteristics of agomelatine users including relevant comorbidities, date, dose, and duration of agomelatine prescriptions and of fluvoxamine and/or ciprofloxacin, date of liver function tests (ALT and AST) and results. The patient survey will collect patients’ characteristics, knowledge of the key liver safety information, and reasons for non-compliance with liver test monitoring when applicable.
• Study status:
  Finalised

Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

Multiple centres: 51 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 02/05/2016

Study start date

Planned: 31/01/2017

Actual: 14/05/2017

Date of interim report, if expected

Planned: 31/07/2017

Date of final study report

Planned: 31/03/2018

Actual: 23/03/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Institut de Recherches Internationales Servier

Study protocol

Initial protocol

Protocole -11.2016

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)