The Study of NPC-06 - Investigation of Safety, Efficacy and Pharmacokinetics of Fosphenytoin

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00908453

Enrollment

Registered

2009-05-25

Start date

2009-05-31

Completion date

2010-02-28

Last updated

2010-05-24

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

Conditions

Epilepsy

Keywords

NPC-06, fosphenytoin, phenytoin, pharmacokinetics, safety

Brief summary

The study is to evaluate safety, efficacy and pharmacokinetics of intravenously administered fosphenytoin in patients with neurosurgery, head trauma, epilepsy or status epilepticus who are requiring a loading dose of phenytoin.

Interventions

DRUGfosphenytoin

15mg/kg, 18mg/kg or 22.5mg/kg of loading doses of fosphenytoin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to No maximum

Healthy volunteers

Inclusion criteria

* male or female, hospitalized patients 2 years of age or older * Adult patients or guardian for pediatric patients to provide written informed consent

Exclusion criteria

* patient with a history of hypersensitivity to hydantoins * patient with hypotension, sinus bradycardia, sino-atrial block, second or third degree A-V block, or Adams-Stokes syndrome * pregnant or nursing female patients

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events	8 to 12 days

Secondary

Measure	Time frame
frequency and nature of seizures	8 to 12 days

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026