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

This study has been completed.
Sponsor:
Information provided by:
Nobelpharma
ClinicalTrials.gov Identifier:
NCT00908453
First received: May 21, 2009
Last updated: May 21, 2010
Last verified: May 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy
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
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

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

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

No publications provided

Responsible Party: Nobelpharma Co., Ltd., CNS group
ClinicalTrials.gov Identifier: NCT00908453     History of Changes
Other Study ID Numbers: NPC-06-2
Study First Received: May 21, 2009
Last Updated: May 21, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Fosphenytoin
 Phenytoin
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013