MedPath

Pharmacokinetic study of KW-6485P

Phase 1
Conditions
Symptomatic or cryptogenic localization related epilepsy
Registration Number
JPRN-jRCT2080220854
Lead Sponsor
Kyowa Hakko Kirin Co., Ltd.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Sex
All
Target Recruitment
25
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath