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

Sponsor

Nobelpharma (Industry)

Overall Status

Completed

CT.gov ID

NCT00908453

Collaborator

(none)

Enrollment

Location

Arms

9.1

Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy	Drug: fosphenytoin	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

Feb 1, 2010

Actual Study Completion Date :

Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 15mg/kg of loading dose	Drug: fosphenytoin 15mg/kg, 18mg/kg or 22.5mg/kg of loading doses of fosphenytoin
Experimental: 18mg/kg of loading dose	Drug: fosphenytoin 15mg/kg, 18mg/kg or 22.5mg/kg of loading doses of fosphenytoin
Experimental: 22.5mg/kg of loading dose	Drug: fosphenytoin 15mg/kg, 18mg/kg or 22.5mg/kg of loading doses of fosphenytoin

Arm

Intervention/Treatment

Experimental: 15mg/kg of loading dose

Drug: fosphenytoin

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

Experimental: 18mg/kg of loading dose

Drug: fosphenytoin

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

Experimental: 22.5mg/kg of loading dose

Drug: fosphenytoin

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

Outcome Measures

Primary Outcome Measures

Incidence of adverse events [8 to 12 days]

Secondary Outcome Measures

frequency and nature of seizures [8 to 12 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years and Older

Sexes Eligible for Study:

All

Accepts 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