ong-term study of KW-6485P (6485P-005)
Phase 3
- Conditions
- Symptomatic or cryptogenic localization-related epilepsy
- Registration Number
- JPRN-jRCT2080221336
- Lead Sponsor
- Kyowa Hakko Kirin Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Patients who have completed the evaluation period for efficacy in the phase III study of KW-6485P
Patients who have provided written informed consent from guardian
Exclusion Criteria
Patients who did not reliably complete their epileptic seizure record in the phase III study of KW-6485P
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety: adverse events
- Secondary Outcome Measures
Name Time Method Efficacy: reduction in the incidence of partial seizure, responder, reduction in the incidence of SGTC<br><br>Pharmacokinetics: plasma KW-6485 concentration