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

Epilepsy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00908453
• Other study ID #: NPC-06-2
• Status: Completed
• Phase: Phase 3
• First received: May 21, 2009
• Last updated: May 21, 2010
• Start date: May 2009
• Est. completion date: February 2010

Study information

• Verified date: May 2010
• Source: Nobelpharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

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

Locations

Country	Name	City	State
Japan	National Center of Neurology and Psychiatry	Kodaira	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Nobelpharma

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		8 to 12 days	No
Secondary	frequency and nature of seizures		8 to 12 days	No