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

Eisai

Status: Completed

Conditions: Lennox-Gastaut Syndrome

Treatments: Drug: Rufinamide

Study type: Observational

Funder types: Industry

Identifiers

NCT02175173

INO01T

Details and patient eligibility

About

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.)

Enrollment: 707 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

All patients with Lennox-Gastaut syndrome and administrated Inovelon

Trial design

707 participants in 1 patient group

E2080

Description:

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.

Treatment:

Drug: Rufinamide