Long-term study of KW-6485P (6485P-005)

Long-term administration study of KW-6485P for pediatric patients (extension from phase III study)

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221336

Enrollment

Registered

2010-12-20

Start date

2010-12-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptomatic or cryptogenic localization-related epilepsy

Interventions

investigational material(s) Generic name etc : KW-6485P INN of investigational material : topiramate Therapeutic category code : 113 Antiepileptics Dosage and Administration for Investigational materi

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Patients who did not reliably complete their epileptic seizure record in the phase III study of KW-6485P

Design outcomes

Primary

Measure	Time frame
Safety: adverse events	—

Secondary

Measure	Time frame
Efficacy: reduction in the incidence of partial seizure, responder, reduction in the incidence of SGTC Pharmacokinetics: plasma KW-6485 concentration	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026