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

NCT01991041 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 109

Last updated 2016-05-04

No results posted yet for this study

Summary

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.

Conditions

  • Lennox-Gastaut Syndrome

Sponsors & Collaborators

  • Eisai Limited

    lead INDUSTRY

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2015-10-31
Completion
2015-11-30

Countries

  • Austria
  • Denmark
  • France
  • Germany
  • Italy
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01991041 on ClinicalTrials.gov