An Open Label Study of Levetiracetam in Japanese Pediatric Patients With Partial Seizures

UCB

Status and phase

Completed

Phase 3

Conditions

Epilepsy

Partial Seizures

Treatments

Drug: Levetiracetam

Study type

Interventional

Funder types

Industry

Identifiers

NCT01063764

N01223

2014-004335-39 (EudraCT Number)

Details and patient eligibility

About

Objective of the First Period: To evaluate the efficacy of Levetiracetam dry syrup at doses up to a maximum of 60 mg/kg/day or 3000 mg/day used as an adjunctive therapy in Japanese pediatric patients (4 to 16 years) with uncontrolled partial seizures despite treatment with 1 or 2 anti-epileptic drug(s).

Full description

Objectives of the Second Period: To provide the Levetiracetam treatment to subjects who are judged by the investigators to benefit from the long-term treatment and who are willing to continuously receive this drug. To continuously evaluate the safety of the Levetiracetam long-term administration at doses ranging from 20 mg/kg/day or 1000 mg/day to 60 mg/kg/day or 3000 mg/day in subjects who completed the First Period of this study.

Enrollment

73 patients

Sex

All

Ages

4 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The patient has partial Epilepsy and the diagnosis must be confirmed in the last 6 months
The patients must be on a stable 1 or 2 anti-epileptic drug(s) treatment during the 4 weeks prior to Baseline and must have at least 8 partial seizures during the 8-week prospective Baseline Period
Patient at the age of 4 to 16 years, and at the body weight of 11 to 82 kg

Exclusion criteria

The patient has a treatable seizure etiology
The patient has Epilepsy secondary to a progressive cerebral disease or any other progressively neurodegenerative disease, including Rasmussen and Landau-Kleffner diseases
The patient has a history of status Epilepticus during the 3 months prior to Visit 1
The patient has a past and present history of pseudo seizures
The patient has a current diagnosis of Lennox-Gastaut syndrome