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

NCT01063764 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2015-03-05

Study results available
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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).

Conditions

Interventions

DRUG

Levetiracetam

First Period: Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks. Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.

Sponsors & Collaborators

  • UCB Japan Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · +1 877 822 9493 (UCB)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-04-30
Completion
2013-10-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01063764 on ClinicalTrials.gov