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

February 10, 2015 updated by: UCB Japan Co. Ltd.

A Double-blind, Randomized, Placebo-controlled 5 Parallel Groups, Confirmatory Trial on the Efficacy and Safety of Levetiracetam Used as add-on Therapy at Doses of 0.5 to 3 g/Day in Patients From 16 to 65 Years With Epilepsy With Partial Onset Seizures Under Treatment With 1 to 3 Anti-epileptic Drug(s)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

352

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chiba, Japan
      • Fukuoka, Japan
      • Gihu, Japan
      • Hiroshima, Japan
      • Kagoshima, Japan
      • Kobe, Japan
      • Kyoto, Japan
      • Miyazaki, Japan
      • Nagaoka, Japan
      • Niigata, Japan
      • Okayama, Japan
      • Osaka, Japan
      • Shizuoka, Japan
      • Tokyo, Japan
      • Toyama, Japan
      • Yamagata, Japan
    • Aichi
      • Aichi-gun, Aichi, Japan
      • Nagoya, Aichi, Japan
      • Nayoga, Aichi, Japan
    • Aomori
      • Hirosaki, Aomori, Japan
    • Fukuoka
      • Kitakyusyu, Fukuoka, Japan
      • Kurume, Fukuoka, Japan
    • Hiroshima
      • Fukuyama, Hiroshima, Japan
    • Hokkaido
      • Asahikawa, Hokkaido, Japan
      • Hakodate, Hokkaido, Japan
      • Sapporo, Hokkaido, Japan
    • Hyogo
      • Kobe, Hyogo, Japan
    • Ishikawa
      • Kahoku-gun, Ishikawa, Japan
    • Kumamoto
      • Kikuchi-gun, Kumamoto, Japan
    • Miyagi
      • Sendai, Miyagi, Japan
    • Nagasaki
      • Omura, Nagasaki, Japan
    • Osaka
      • Izumi, Osaka, Japan
      • Neyagawa, Osaka, Japan
      • Suita, Osaka, Japan
    • Tochigi
      • Kawachi-gun, Tochigi, Japan
    • Tokyo
      • Kodaira, Tokyo, Japan
    • Yamaguchi
      • Ube, Yamaguchi, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Epileptic patients who fulfill the following criteria are eligible for inclusion in the study:

  • Subjects aged from 16 to 65 years at the acquisition of informed consent to the trial participation
  • Seizure type: subjects with epileptic seizures which were diagnosed as partial seizures more than 2 years ago according to "Clinical and electroencephalographic classification of epileptic seizures (1981)" defined by the International League Against Epilepsy (ILAE) and confirmed with an EEG that has been performed within 1 year before Screening or at the Screening Visit
  • Subjects whose previous therapy before screening involved at least two standard anti-epileptic drugs (AEDs) for partial seizures, and in whom it can be confirmed that the doses met the daily dose specified for the treatment of epilepsy in the package insert and that the therapy has been continued for at least 3 months
  • Frequency of epileptic seizures: subjects experiencing partial seizures at least 12 times in 12 weeks during the Baseline Period (Week -12 to Week 0) and at least twice in every 4 weeks

Exclusion Criteria:

The following patients are not eligible for inclusion into the study:

  • Subjects who were diagnosed with status epilepticus within 3 months before screening
  • Subjects with no partial seizures of which frequency was measured during the Baseline Period
  • Subjects who underwent surgery for epilepsy within 2 years before Screening or who were scheduled to undergo brain surgery during the study period and within 4 weeks after the completion of this study
  • Subjects with a history of oral treatment with Levetiracetam (LEV)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lev 0.5 g
Levetiracetam 0.5 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).
Drug: Levetiracetam 250 mg
  • Active Substance: Levetiracetam
  • Pharmaceutical Form: Film-coated tablet
  • Concentration: 250 mg
  • Route of Administration: Oral Use
Other Names:
  • Keppra
Experimental: Lev 1 g
Levetiracetam 1 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).
Drug: Levetiracetam 250 mg
  • Active Substance: Levetiracetam
  • Pharmaceutical Form: Film-coated tablet
  • Concentration: 250 mg
  • Route of Administration: Oral Use
Other Names:
  • Keppra
Drug: Levetiracetam 500 mg
  • Active Substance: Levetiracetam
  • Pharmaceutical Form: Film-coated tablet
  • Concentration: 500 mg
  • Route of Administration: Oral Use
Other Names:
  • Keppra
Experimental: Lev 2 g
Levetiracetam 2 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).
Drug: Levetiracetam 250 mg
  • Active Substance: Levetiracetam
  • Pharmaceutical Form: Film-coated tablet
  • Concentration: 250 mg
  • Route of Administration: Oral Use
Other Names:
  • Keppra
Drug: Levetiracetam 500 mg
  • Active Substance: Levetiracetam
  • Pharmaceutical Form: Film-coated tablet
  • Concentration: 500 mg
  • Route of Administration: Oral Use
Other Names:
  • Keppra
Experimental: Lev 3 g
Levetiracetam 3 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).
Drug: Levetiracetam 250 mg
  • Active Substance: Levetiracetam
  • Pharmaceutical Form: Film-coated tablet
  • Concentration: 250 mg
  • Route of Administration: Oral Use
Other Names:
  • Keppra
Drug: Levetiracetam 500 mg
  • Active Substance: Levetiracetam
  • Pharmaceutical Form: Film-coated tablet
  • Concentration: 500 mg
  • Route of Administration: Oral Use
Other Names:
  • Keppra
Placebo Comparator: Placebo
Placebo tablets as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).
Other: Placebo
  • Active Substance: Placebo
  • Pharmaceutical Form: Film-coated tablet
  • Concentration: 250 mg and 500 mg
  • Route of Administration: Oral Use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent reduction from Baseline in partial (Type I) seizure frequency per week over the Evaluation Period
Time Frame: From Baseline to the 12-week Evaluation Period
From Baseline to the 12-week Evaluation Period

Secondary Outcome Measures

Outcome Measure
Time Frame
Partial (Type I) seizure frequency per week over the Evaluation Period
Time Frame: 12-week Evaluation Period
12-week Evaluation Period
Partial (Type I) seizure responder rates (50 %, 75 %) over the Evaluation Period
Time Frame: From Baseline to the 12-week Evaluation Period
From Baseline to the 12-week Evaluation Period
Seizure freedom over the Evaluation Period
Time Frame: 12-week Evaluation Period
12-week Evaluation Period
Categorized percentage reduction from Baseline in partial (Type I) seizure frequency per week over the Evaluation Period
Time Frame: From Baseline to the 12-week Evaluation Period
From Baseline to the 12-week Evaluation Period
Percentage reduction from Baseline in seizure frequency per week by seizure subtype (IA, IB, IC, IA + IB, other) over the Evaluation Period
Time Frame: From Baseline to the 12-week Evaluation Period
From Baseline to the 12-week Evaluation Period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Japan Co. Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

January 19, 2006

First Submitted That Met QC Criteria

January 20, 2006

First Posted (Estimate)

January 23, 2006

Study Record Updates

Last Update Posted (Estimate)

February 11, 2015

Last Update Submitted That Met QC Criteria

February 10, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N01221
  • 2014-004333-57 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Epilepsies, Partial

Clinical Trials on Levetiracetam 250 mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe