Phase III study of KW-6485P (6485P-004)

Phase 3

• Conditions: Symptomatic or cryptogenic localization-related epilepsy

• Registration Number: JPRN-jRCT2080221158
• Lead Sponsor: Kyowa Hakko Kirin Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 60

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

- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified