A global postmarketing observational safety study to evaluate the safety and tolerability of Fycompa (perampanel) as add-on therapy in epilepsy patients aged > 12 years

Study identification

• EU PAS number:
  EUPAS10320
• Study ID:
  38590
• Official title and acronym:
  A global postmarketing observational safety study to evaluate the safety and tolerability of Fycompa (perampanel) as add-on therapy in epilepsy patients aged > 12 years
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Denmark

  France

  Israel

  Russian Federation

  Spain

  Sweden

  United Kingdom
• Study description:
  The objective of the study is to address the need for additional safety information on AEs of interest in the categories of important identified risks, important potential risks, and important missing information in the EU Risk Management Plan (RMP) for perampanelgiven as add-on therapy in patients with epilepsy.This will be achieved by assessment of events of dizziness, blurred vision, somnolence, aggression, balance disorders, ataxia, falls, unintended pregnancy, weight gain, suicidality, drug abuse, misuse, dependence, withdrawal, off-label use, skin photosensitivity, unintendedpregnancy while taking levonorgestrel-containing contraceptives, and outcomes associated with any suspected drug-drug interaction.
• Study status:
  Finalised

Research institutions and networks

Institutions

Eisai

Multiple centres: 100 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:05/12/2012

Actual:05/12/2012

Study start date

Actual:06/06/2014

Data analysis start date

Planned:30/06/2017

Date of final study report

Planned:31/12/2017

Actual:24/07/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eisai Ltd

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)