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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
352
* 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
Unnamed facility
Aichi-gun, Aichi-ken, Japan
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
Partial (Type I) seizure frequency per week over the Evaluation Period
Time frame: 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
Seizure freedom over the Evaluation Period
Time frame: 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
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
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Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Nayoga, Aichi-ken, Japan
Unnamed facility
Hirosaki, Aomori, Japan
Unnamed facility
Chiba, Chiba, Japan
Unnamed facility
Fukuoka, Fukuoka, Japan
Unnamed facility
Kitakyushu, Fukuoka, Japan
Unnamed facility
Kurume, Fukuoka, Japan
Unnamed facility
Gifu, Gihu, Japan
Unnamed facility
Fukuyama, Hiroshima, Japan
...and 27 more locations