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A Study of Levetiracetam in Japanese Pediatric Patients With Generalized Tonic-clonic Seizures

NCT01292837 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2015-05-15

Study results available
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Summary

To evaluate the efficacy and safety of Levetiracetam dry syrup at doses up to 60 mg/kg/day or 3000 mg/day used as adjunctive therapy in Japanese pediatric patients aged ≥4 to \<16 years with uncontrolled Generalized Tonic-Clonic (GTC) seizures despite treatment with 1 or 2 Anti-Epileptic Drugs (AEDs).

Conditions

  • Epilepsy
  • Generalized Tonic-clonic Seizures

Interventions

DRUG

Levetiracetam

The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks.

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
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-06-30
Completion
2013-06-30

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 NCT01292837 on ClinicalTrials.gov