European Registry of Anti-Epileptic Drug Use in Patients with Lennox-Gastaut Syndrome (LGS)

Study identification

• EU PAS number:
  EUPAS5180
• Study ID:
  38601
• Official title and acronym:
  European Registry of Anti-Epileptic Drug Use in Patients with Lennox-Gastaut Syndrome (LGS)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Denmark

  France

  Germany

  Italy

  Spain

  Sweden

  United Kingdom
• Study description:
  This is a registry study, where sites will enter patients with LGS who require a modification in anti-epileptic therapy (either the addition of another anti-epileptic drug, or the change of one drug to another). This will include patients who are started on rufinamide. Patients will be reviewed according to local practice, but it is envisaged that review will occur at approximately one month, three months and six months, and then every six months. Upon entry to the registry baseline details concerning disease severity, diagnosis, prior therapy, and developmental assessment will be recorded. On each subsequent visit the patient (usually through their caregiver) will be asked about current medication, general seizure profile, any seizures deemed to be of medical significance, tolerability, AEs (including suicidal-related events), and healthcare resource utilisation.
• Study status:
  Finalised

Research institutions and networks

Institutions

Eisai

Multiple centres: 49 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 01/05/2008

Study start date

Actual: 30/07/2008

Data analysis start date

Actual: 01/08/2011

Date of interim report, if expected

Planned: 01/12/2013

Date of final study report

Planned: 01/03/2017

Actual: 05/09/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eisai Limited

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)