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

Completed

• Conditions: Lennox-Gastaut Syndrome

• Registration Number: NCT01991041
• Lead Sponsor: Eisai Limited

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2013-11-18
• Study First Submitted QC: 2013-11-18
• Study First Posted: 2013-11-25
• Primary Completion: 2015-10
• Study Completion: 2015-11
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-03
• Last Update Posted: 2016-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety during the use of rufinamide and other anti-epileptic drugs	At least three years	Evaluation of the incidence of seizures of medical significance (including status epilepticus, new / worsening of seizure types and withdrawal seizures) during exposure to anti-epileptic drugs, including rufinamide, in patients with LGS; incidence of hypersensitivity reactions during the exposure to anti-epileptic drugs, including rufinamide; common AEs identified with anti-epileptic drugs, as they may be related to this specific population; including sedation, neurological AEs, suicidal-related events, events associated with blood dyscrasias, and the potential increased risk of infections.

Secondary Outcome Measures

Name	Time	Method
Long term use of rufinamide, and other anti-epileptic drugs	At least three years	Evaluation, within the constraints of this population, of the impact on maturation anddevelopment that anti-epileptic drugs, including rufinamide, has on the LGS population; seizure control in LGS patients, including those taking rufinamide and other anti-epileptic drugs; assessment of healthcare resource utilisation.