Post-marketing Surveillance of Long-term Administration of Inovelon Tablets in Patients With Lennox-Gastaut Syndrome

Completed

• Conditions: Lennox-Gastaut Syndrome
• Interventions: Drug: Rufinamide

• Registration Number: NCT02175173
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

This surveillance's objectives are

1. Unknown adverse reactions

2. Incidences of adverse drug reaction

3. Efficacy during long-term administration

4. Factors considered to have effect to safety and effectiveness

5. Incidences of status epileptics, skin disorders and hyper sensitivity reaction, and central nervous system-related adverse events(ataxia , somnolence and/or dizzy, etc.)

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-13
• Study First Submitted: 2014-06-10
• Study First Submitted QC: 2014-06-24
• Study First Posted: 2014-06-26
• Status Verified: 2022-11
• Primary Completion: 2022-11-02
• Study Completion: 2022-11-02
• Last Update Submitted: 2023-02-17
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 707

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
E2080	Rufinamide	Children ages \>= 4 years: Patients weighing 15.0-30.0 kg: oral daily dose of 200 mg in two divided doses after meals for the first 2 days. The dose will be increased by up to 200 mg/day every two days. The maintenance dose should be 1000 mg/day in two divided doses after meals. The dose can be increased or decreased within a range not exceeding 1000 mg/day, and should be increased by up to 200 mg/day at intervals not less than 2 days. Patients weighing \>= 30.1 kg: Adults: oral daily dose of 400 mg in two divided doses after meals for the first 2 days, then increased by up to 400 mg/day every two days. The maintenance dose should be 1800 mg/day for patients weighing 30.1-50.0 kg, 2400 mg/day for patients weighing 50.1-70.0 kg, and 3200 mg/day for patients weighing 70.1 kg or over in two divided doses after meals. Dose can be increased or decreased within a range not exceeding the above maintenance dose, and should be increased by up to 400 mg/day at intervals not less than 2 days.

Primary Outcome Measures

Name	Time	Method
Investigations on adverse events and adverse drug reactions	Up to 2 years

Secondary Outcome Measures

Name	Time	Method
Overall assessments of the improvement in the seriousness of seizures	12 weeks and every 6 months up to 2years
Frequency of attacks	12 weeks and every 6 months up to 2years