Symptomatic or cryptogenic localization related epilepsy
Conditions
Sponsors
Kyowa Hakko Kirin Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who have been diagnosed with symptomatic or cryptogenic localization related epilepsy Patients who have simple partial seizure, complex partial seizure, or secondarily generalized seizure Patients who have provided written informed consent from guardian Patients who experience partial seizure regardless of the treatment of other antiepileptic drugs Patients who have no progressive disease of central nervous system with imaging diagnosis
Exclusion criteria
Exclusion criteria: Patients with seizures secondarily to a treatable diseases Patients with seizures other than partial seizures Patients with a serious disorder of cardiac, hepatic, renal, pulmonary, hematologic, metabolic, or endocrinologic system Patients with a progressive neurological disorder Patients with a complication or history of severe psychiatric symptom Patients with a history of renal or urinary calculus Patients with a complication or history of angle-closure glaucoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: plasma topiramate concentration Safety: adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: incidence of epileptic seizures | — |
Outcome results
None listed