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A Double-blind Confirmatory Trial of Levetiracetam in Epilepsy Patients With Partial Onset Seizures

NCT00280696 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2015-02-11

No results posted yet for this study

Summary

A double-blind, randomized, multicenter, placebo controlled 5 parallel groups, confirmatory trial to evaluated the efficacy and safety of levetiracetam used as adjunctive treatment in patients from 16 to 65 years with epilepsy suffering from partial onset seizures.

Conditions

  • Epilepsies, Partial

Interventions

DRUG

Levetiracetam 250 mg

* Active Substance: Levetiracetam * Pharmaceutical Form: Film-coated tablet * Concentration: 250 mg * Route of Administration: Oral Use

DRUG

Levetiracetam 500 mg

* Active Substance: Levetiracetam * Pharmaceutical Form: Film-coated tablet * Concentration: 500 mg * Route of Administration: Oral Use

OTHER

Placebo

* Active Substance: Placebo * Pharmaceutical Form: Film-coated tablet * Concentration: 250 mg and 500 mg * Route of Administration: Oral Use

Sponsors & Collaborators

  • UCB Japan Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · UCB Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2007-11-30
Completion
2007-11-30

Countries

  • Japan

Study Locations

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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 NCT00280696 on ClinicalTrials.gov