A Double-blind Confirmatory Trial of L059 (Levetiracetam) in Epilepsy Patients With Partial Onset Seizures

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00280696
First received: January 19, 2006
Last updated: December 5, 2013
Last verified: September 2009
  Purpose

A double-blind, randomized, multicenter, placebo controlled 5 parallel groups, confirmatory trial to evaluated the efficacy and safety of L059 (levetiracetam) used as adjunctive treatment in patients from 16 to 65 years with epilepsy suffering from partial onset seizures.


Condition Intervention Phase
Epilepsies, Partial
Drug: Levetiracetam
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo-controlled 5 Parallel Groups, Confirmatory Trial on the Efficacy and Safety of L059 (Levetiracetam) Used as add-on Therapy in Patients From 16 to 65 Years With Epilepsy With Partial Onset Seizures Under Treatment With Anti-epileptic Drugs

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Percent reduction of partial seizure frequency per week

Secondary Outcome Measures:
  • Seizures frequency per week
  • Safety

Enrollment: 352
Study Start Date: November 2005
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

    1. Age at the start of the baseline period: 16 years old ≤ age <65 years old
    2. Patients with epileptic seizures which were diagnosed as partial seizures more than 2 years ago according to "the revised clinical and electroencephalographic classification of epileptic seizures in 1981" and confirmed with an EEG.
    3. Patients treated with one to three anti-epileptic drugs.

      Exclusion Criteria:

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

    1. Frequency of epileptic seizures: patients diagnosed with epileptic status within 3 months before screening.
    2. Patients with history of cerebrovascular disease including transient ischemic attack (TIA), and those with concurrent distinct symptoms of central nervous system disorders (Alzheimer's disease, brain tumor, etc.) that cause progressive cerebral disorder or progressive neurological disorder.
    3. Patient with mental disease requiring or having required hospitalization within the past 2 years or having a past history of attempted suicide
    4. Patients who underwent surgery for epilepsy within 2 years before screening or who are scheduled to undergo brain surgery during the present study period and within 4 weeks after the completion of the present study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280696

Locations
Japan
Aichi-gun, Aichi, Japan
Nagoya, Aichi, Japan
Nayoga, Aichi, Japan
Hirosaki, Aomori, Japan
Kitakyusyu, Fukuoka, Japan
Kurume, Fukuoka, Japan
Fukuyama, Hiroshima, Japan
Asahikawa, Hokkaido, Japan
Hakodate, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Kobe, Hyogo, Japan
Kahoku-gun, Ishikawa, Japan
Kikuchi-gun, Kumamoto, Japan
Sendai, Miyagi, Japan
Omura, Nagasaki, Japan
Izumi, Osaka, Japan
Neyagawa, Osaka, Japan
Suita, Osaka, Japan
Kawachi-gun, Tochigi, Japan
Kodaira, Tokyo, Japan
Ube, Yamaguchi, 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
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center UCB, Inc.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00280696     History of Changes
Other Study ID Numbers: N01221
Study First Received: January 19, 2006
Last Updated: December 5, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by UCB, Inc.:
Epilepsies, Partial,
Keppra, levetiracetam

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Etiracetam
Anticonvulsants
Piracetam
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014