A Double-blind Confirmatory Trial of Levetiracetam in Epilepsy Patients With Partial Onset Seizures
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)
2 other identifiers
interventional
352
1 country
37
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2005
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 19, 2006
CompletedFirst Posted
Study publicly available on registry
January 23, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedFebruary 11, 2015
February 1, 2015
2 years
January 19, 2006
February 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent reduction from Baseline in partial (Type I) seizure frequency per week over the Evaluation Period
From Baseline to the 12-week Evaluation Period
Secondary Outcomes (5)
Partial (Type I) seizure frequency per week over the Evaluation Period
12-week Evaluation Period
Partial (Type I) seizure responder rates (50 %, 75 %) over the Evaluation Period
From Baseline to the 12-week Evaluation Period
Seizure freedom over the Evaluation Period
12-week Evaluation Period
Categorized percentage reduction from Baseline in partial (Type I) seizure frequency per week over the 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
From Baseline to the 12-week Evaluation Period
Study Arms (5)
Lev 0.5 g
EXPERIMENTALLevetiracetam 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).
Lev 1 g
EXPERIMENTALLevetiracetam 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).
Lev 2 g
EXPERIMENTALLevetiracetam 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).
Lev 3 g
EXPERIMENTALLevetiracetam 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).
Placebo
PLACEBO COMPARATORPlacebo tablets as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).
Interventions
* Active Substance: Levetiracetam * Pharmaceutical Form: Film-coated tablet * Concentration: 250 mg * Route of Administration: Oral Use
* Active Substance: Levetiracetam * Pharmaceutical Form: Film-coated tablet * Concentration: 500 mg * Route of Administration: Oral Use
* Active Substance: Placebo * Pharmaceutical Form: Film-coated tablet * Concentration: 250 mg and 500 mg * Route of Administration: Oral Use
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Unknown Facility
Aichi-gun, Aichi-ken, Japan
Unknown Facility
Nagoya, Aichi-ken, Japan
Unknown Facility
Nayoga, Aichi-ken, Japan
Unknown Facility
Hirosaki, Aomori, Japan
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Chiba, Chiba, Japan
Unknown Facility
Fukuoka, Fukuoka, Japan
Unknown Facility
Kitakyushu, Fukuoka, Japan
Unknown Facility
Kurume, Fukuoka, Japan
Unknown Facility
Gifu, Gihu, Japan
Unknown Facility
Fukuyama, Hiroshima, Japan
Unknown Facility
Hiroshima, Hiroshima, Japan
Unknown Facility
Asahikawa, Hokkaido, Japan
Unknown Facility
Hakodate, Hokkaido, Japan
Unknown Facility
Sapporo, Hokkaido, Japan
Unknown Facility
Kobe, Hyōgo, Japan
Unknown Facility
Kahoku-gun, Ishikawa-ken, Japan
Unknown Facility
Kagoshima, Kagoshima-ken, Japan
Unknown Facility
Kikuchi-gun, Kumamoto, Japan
Unknown Facility
Kyoto, Kyoto, Japan
Unknown Facility
Sendai, Miyagi, Japan
Unknown Facility
Miyazaki, Miyazaki, Japan
Unknown Facility
Nagaoka, Nagaoka, Japan
Unknown Facility
Ōmura, Nagasaki, Japan
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Niigata, Niigata, Japan
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Okayama, Okayama-ken, Japan
Unknown Facility
Izumi, Osaka, Japan
Unknown Facility
Neyagawa, Osaka, Japan
Unknown Facility
Osaka, Osaka, Japan
Unknown Facility
Suita, Osaka, Japan
Unknown Facility
Shizuoka, Shizuoka, Japan
Unknown Facility
Kawachi-gun, Tochigi, Japan
Unknown Facility
Kodaira, Tokyo, Japan
Unknown Facility
Tokyo, Tokyo, Japan
Unknown Facility
Toyama, Toyama, Japan
Unknown Facility
Yamagata, Yamagata, Japan
Unknown Facility
Ube, Yamaguchi, Japan
Unknown Facility
Kobe, Japan
Related Publications (1)
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.
PMID: 25854635DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
UCB Pharma
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2006
First Posted
January 23, 2006
Study Start
November 1, 2005
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
February 11, 2015
Record last verified: 2015-02