Skip to main content
OpenTrials
Completed

NCT Number: NCT00908453

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Center of Neurology and Psychiatry

Kodaira, Tokyo, 187-8551, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fosphenytoin

Drug

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

Primary outcomes

  1. Incidence of adverse events

    Time frame: 8 to 12 days

Secondary outcomes

  1. frequency and nature of seizures

    Time frame: 8 to 12 days

Sponsors and collaborators

Lead sponsor

Nobelpharma

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 25, 2009
Registry last updated
May 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.