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

This study is currently recruiting participants.

Verified by Nobelpharma, May 2009

First Received: May 21, 2009 Last Updated: May 22, 2009 History of Changes

Sponsor:	Nobelpharma
Information provided by:	Nobelpharma
ClinicalTrials.gov Identifier:	NCT00908453

Purpose

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	Intervention	Phase
Epilepsy	Drug: fosphenytoin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy

Drug Information available for: Fosphenytoin sodium Fosphenytoin

U.S. FDA Resources

Further study details as provided by Nobelpharma:

Primary Outcome Measures:

Incidence of adverse events [ Time Frame: 8 to 12 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

frequency and nature of seizures [ Time Frame: 8 to 12 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	May 2009
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
15mg/kg of loading dose: Experimental	Drug: fosphenytoin 15mg/kg, 18mg/kg or 22.5mg/kg of loading doses of fosphenytoin
18mg/kg of loading dose: Experimental	Drug: fosphenytoin 15mg/kg, 18mg/kg or 22.5mg/kg of loading doses of fosphenytoin
22.5mg/kg of loading dose: Experimental	Drug: fosphenytoin 15mg/kg, 18mg/kg or 22.5mg/kg of loading doses of fosphenytoin

Eligibility

Ages Eligible for Study:	2 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00908453

Contacts

Contact: Kenji Shimizu

+81-3-5651-1206

shimizu@nobelpharma.co.jp

Locations

Japan, Tokyo
National Center of Neurology and Psychiatry	Recruiting
Kodaira, Tokyo, Japan, 187-8551
Contact: Nakagawa nakagawa@ncnp.go.jp

Sponsors and Collaborators

Nobelpharma

Investigators

Study Director:

Eiji Nakagawa, M.D.

National Center of Neurology and Psychiatry

More Information

No publications provided

Responsible Party:	CNS group ( Nobelpharma Co., Ltd. )
Study ID Numbers:	NPC-06-2
Study First Received:	May 21, 2009
Last Updated:	May 22, 2009
ClinicalTrials.gov Identifier:	NCT00908453 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Nobelpharma:

NPC-06
fosphenytoin
phenytoin
pharmacokinetics
safety

Additional relevant MeSH terms:

Phenytoin
Epilepsy
Therapeutic Uses
Nervous System Diseases
Central Nervous System Diseases

Brain Diseases
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants
Fosphenytoin

ClinicalTrials.gov processed this record on February 04, 2010