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 must weigh at least 10 kg - Patients who have any epilepsy therapy for 6 months or more - Patients who are treated with 1 to 3 antiepileptic drugs - Patients who have no progressive disease of central nervous system with imaging diagnosis
Exclusion criteria
Exclusion criteria: - Patients with status epilepticus within 3 months - Patients with seizures secondarily to a treatable diseases - Patients with seizures other than partial seizures - Patients with seizures occurring only in clustered patterns - 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 - Patients with a prior exposure to topiramate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: reduction in the incidence of partial seizure during the evaluation period for efficacy | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: reduction in the incidence of partial seizure, responder, reduction in the incidence of SGTC Safety: adverse events Pharmacokinetics: plasma KW-6485 concentration | — |
Outcome results
None listed