Epilepsy
Conditions
Keywords
Levetiracetam, Keppra
Brief summary
Double-blind, randomized, placebo-controlled, multi center trial to evaluate the efficacy and safety of levetiracetam as adjunctive treatment in adult Japanese epileptic subjects with partial onset seizures.
Interventions
DRUGLevetiracetam
Sponsors
UCB Japan Co. Ltd.
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* simple and/or complex partial seizures with or without secondary generalization, and first partial seizure \>= 2 years before selection visit; * seizures classifiable according to the ILAE classification; * minimum of 12 partial seizures per 12 weeks with a minimum of two partial seizures per 4 weeks from the selection visit to the end of the baseline period ; * exposed to two or more standard AEDs; * taking up to three of the standard AEDs, at the initiation of the trial.
Exclusion criteria
* medication influencing the CNS, except for medication taken for antiepileptic treatment; * partial seizures uncountable due to clustering, including status epileptics, during the 3 months prior to the selection visit; * history of cerebrovascular disease including transient ischemic attack (TIA) and progressive cerebral disorder or progressive neurological disorder; * presence or history of any clinically significant allergic condition and complication or history of significant alcohol abuse or drug abuse in the past.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| partial onset seizure frequency per week | collection of seizure count throughout the whole study (baseline and treatment periods) |
Secondary
| Measure | Time frame |
|---|---|
| safety and tolerability | safety and tolerability data were collected throughout the study period |
Outcome results
None listed