A Double-blind Confirmatory Trial of Levetiracetam in Epilepsy Patients With Partial Onset Seizures
NCT ID: NCT00280696
Last Updated: 2015-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
352 participants
INTERVENTIONAL
2005-11-30
2007-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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).
Levetiracetam 250 mg
* Active Substance: Levetiracetam
* Pharmaceutical Form: Film-coated tablet
* Concentration: 250 mg
* Route of Administration: Oral Use
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).
Levetiracetam 250 mg
* Active Substance: Levetiracetam
* Pharmaceutical Form: Film-coated tablet
* Concentration: 250 mg
* Route of Administration: Oral Use
Levetiracetam 500 mg
* Active Substance: Levetiracetam
* Pharmaceutical Form: Film-coated tablet
* Concentration: 500 mg
* Route of Administration: Oral Use
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).
Levetiracetam 250 mg
* Active Substance: Levetiracetam
* Pharmaceutical Form: Film-coated tablet
* Concentration: 250 mg
* Route of Administration: Oral Use
Levetiracetam 500 mg
* Active Substance: Levetiracetam
* Pharmaceutical Form: Film-coated tablet
* Concentration: 500 mg
* Route of Administration: Oral Use
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).
Levetiracetam 250 mg
* Active Substance: Levetiracetam
* Pharmaceutical Form: Film-coated tablet
* Concentration: 250 mg
* Route of Administration: Oral Use
Levetiracetam 500 mg
* Active Substance: Levetiracetam
* Pharmaceutical Form: Film-coated tablet
* Concentration: 500 mg
* Route of Administration: Oral Use
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).
Placebo
* Active Substance: Placebo
* Pharmaceutical Form: Film-coated tablet
* Concentration: 250 mg and 500 mg
* Route of Administration: Oral Use
Interventions
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Levetiracetam 250 mg
* Active Substance: Levetiracetam
* Pharmaceutical Form: Film-coated tablet
* Concentration: 250 mg
* Route of Administration: Oral Use
Levetiracetam 500 mg
* Active Substance: Levetiracetam
* Pharmaceutical Form: Film-coated tablet
* Concentration: 500 mg
* Route of Administration: Oral Use
Placebo
* Active Substance: Placebo
* Pharmaceutical Form: Film-coated tablet
* Concentration: 250 mg and 500 mg
* Route of Administration: Oral Use
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
16 Years
65 Years
ALL
No
Sponsors
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UCB Japan Co. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
UCB Pharma
Locations
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Aichi-gun, Aichi-ken, Japan
Nagoya, Aichi-ken, Japan
Nayoga, Aichi-ken, Japan
Hirosaki, Aomori, Japan
Chiba, Chiba, Japan
Fukuoka, Fukuoka, Japan
Kitakyushu, Fukuoka, Japan
Kurume, Fukuoka, Japan
Gifu, Gihu, Japan
Fukuyama, Hiroshima, Japan
Hiroshima, Hiroshima, Japan
Asahikawa, Hokkaido, Japan
Hakodate, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Kobe, Hyōgo, Japan
Kahoku-gun, Ishikawa-ken, Japan
Kagoshima, Kagoshima-ken, Japan
Kikuchi-gun, Kumamoto, Japan
Kyoto, Kyoto, Japan
Sendai, Miyagi, Japan
Miyazaki, Miyazaki, Japan
Nagaoka, Nagaoka, Japan
Ōmura, Nagasaki, Japan
Niigata, Niigata, Japan
Okayama, Okayama-ken, Japan
Izumi, Osaka, Japan
Neyagawa, Osaka, Japan
Osaka, Osaka, Japan
Suita, Osaka, Japan
Shizuoka, Shizuoka, Japan
Kawachi-gun, Tochigi, Japan
Kodaira, Tokyo, Japan
Tokyo, Tokyo, Japan
Toyama, Toyama, Japan
Yamagata, Yamagata, Japan
Ube, Yamaguchi, Japan
Kobe, , Japan
Countries
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References
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Inoue Y, Yagi K, Ikeda A, Sasagawa M, Ishida S, Suzuki A, Yoshida K; Japan Levetiracetam N01221 Study Group. Efficacy and tolerability of levetiracetam as adjunctive therapy in Japanese patients with uncontrolled partial-onset seizures. Psychiatry Clin Neurosci. 2015 Oct;69(10):640-8. doi: 10.1111/pcn.12300. Epub 2015 May 13.
Other Identifiers
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2014-004333-57
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
N01221
Identifier Type: -
Identifier Source: org_study_id
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