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
Endpoint Classification: Safety/Efficacy Study
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 ] [ 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


Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Nobelpharma:

Additional relevant MeSH terms:
Anticonvulsants processed this record on May 26, 2016