NCT01991041

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 109 (actual)
• Sponsor: Eisai Limited · Industry
• Sex: All
• Age: 4 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2008-06-01
• Primary completion: 2015-10-01
• Completion: 2015-11-01
• First posted: 2013-11-25
• Last updated: 2016-05-04

Locations

49 sites across 8 countries: Austria, Denmark, France, Germany, Italy, Spain, Sweden, United Kingdom