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

This study has been completed.
Information provided by:
Nobelpharma Identifier:
First received: May 21, 2009
Last updated: May 21, 2010
Last verified: May 2010
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
Drug: fosphenytoin
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Nobelpharma:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: 8 to 12 days ]

Secondary Outcome Measures:
  • frequency and nature of seizures [ Time Frame: 8 to 12 days ]

Estimated Enrollment: 40
Study Start Date: May 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00908453

National Center of Neurology and Psychiatry
Kodaira, Tokyo, Japan, 187-8551
Sponsors and Collaborators
Study Director: Eiji Nakagawa, M.D. National Center of Neurology and Psychiatry
  More Information

Responsible Party: Nobelpharma Co., Ltd., CNS group Identifier: NCT00908453     History of Changes
Other Study ID Numbers: NPC-06-2
Study First Received: May 21, 2009
Last Updated: May 21, 2010

Keywords provided by Nobelpharma:

Additional relevant MeSH terms:
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers processed this record on April 28, 2017