Epilepsies, Partial
Conditions
Keywords
Epilepsies, Partial,, Keppra, levetiracetam
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.
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
OTHERPlacebo
* Active Substance: Placebo * Pharmaceutical Form: Film-coated tablet * Concentration: 250 mg and 500 mg * Route of Administration: Oral Use
Sponsors
UCB Japan Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Japan
Outcome results
None listed