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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Japan Co. Ltd. )
ClinicalTrials.gov Identifier:
NCT00280696
First received: January 19, 2006
Last updated: February 10, 2015
Last verified: February 2015
  Purpose

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.


Condition Intervention Phase
Epilepsies, Partial
Drug: Levetiracetam 250 mg
Drug: Levetiracetam 500 mg
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Partial (Type I) seizure frequency per week over the Evaluation Period [ Time Frame: 12-week Evaluation Period ] [ Designated as safety issue: No ]
  • Partial (Type I) seizure responder rates (50 %, 75 %) over the Evaluation Period [ Time Frame: From Baseline to the 12-week Evaluation Period ] [ Designated as safety issue: No ]
  • Seizure freedom over the Evaluation Period [ Time Frame: 12-week Evaluation Period ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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)
Arms Assigned Interventions
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 Name: 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 Name: Keppra
Drug: Levetiracetam 500 mg
  • Active Substance: Levetiracetam
  • Pharmaceutical Form: Film-coated tablet
  • Concentration: 500 mg
  • Route of Administration: Oral Use
Other Name: 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 Name: Keppra
Drug: Levetiracetam 500 mg
  • Active Substance: Levetiracetam
  • Pharmaceutical Form: Film-coated tablet
  • Concentration: 500 mg
  • Route of Administration: Oral Use
Other Name: 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 Name: Keppra
Drug: Levetiracetam 500 mg
  • Active Substance: Levetiracetam
  • Pharmaceutical Form: Film-coated tablet
  • Concentration: 500 mg
  • Route of Administration: Oral Use
Other Name: 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

  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:

  • 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)
  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 Japan Co. Ltd.
Investigators
Study Director: UCB Clinical Trial Call Center UCB Pharma
  More Information

Additional Information:
No publications provided

Responsible Party: UCB Pharma ( UCB Japan Co. Ltd. )
ClinicalTrials.gov Identifier: NCT00280696     History of Changes
Other Study ID Numbers: N01221, 2014-004333-57
Study First Received: January 19, 2006
Last Updated: February 10, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by UCB Pharma:
Epilepsies, Partial,
Keppra, levetiracetam

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

ClinicalTrials.gov processed this record on May 27, 2015