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

Nobelpharma40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Epilepsy

Interventions

fosphenytoinDRUG

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

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

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

Locations (1)

National Center of Neurology and Psychiatry

Kodaira, Tokyo, Japan

Outcomes

Primary Outcomes

Incidence of adverse events

Time frame: 8 to 12 days

Secondary Outcomes

frequency and nature of seizures

Time frame: 8 to 12 days

Data from ClinicalTrials.gov

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