Long-term study of KW-6485P

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

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220855

Enrollment

Registered

2009-09-09

Start date

2009-09-09

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 and been eligible for the pharmacokinetic study of KW-6485P for pediatric patients 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 pharmacokinetic study of KW-6485P for pediatric patients

Design outcomes

Primary

Measure	Time frame
Safety: adverse events	—

Secondary

Measure	Time frame
Efficacy: incidence of epileptic seizures Pharmacokinetics: plasma topiramate concentration	—

Outcome results

None listed

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