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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00908453
First Posted: May 25, 2009
Last Update Posted: May 24, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nobelpharma
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00908453


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

Responsible Party: Nobelpharma Co., Ltd., CNS group
ClinicalTrials.gov Identifier: NCT00908453     History of Changes
Other Study ID Numbers: NPC-06-2
First Submitted: May 21, 2009
First Posted: May 25, 2009
Last Update Posted: May 24, 2010
Last Verified: May 2010

Keywords provided by Nobelpharma:
NPC-06
fosphenytoin
phenytoin
pharmacokinetics
safety

Additional relevant MeSH terms:
Fosphenytoin
Phenytoin
Anticonvulsants
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