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

2014-08-27 03:16:07 | BioPortfolio

Summary

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).

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Epilepsy

Intervention

Levetiracetam

Location

Chuo
Japan

Status

Recruiting

Source

UCB, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:07-0400

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Medical and Biotech [MESH] Definitions

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