Status:
COMPLETED
The Study of NPC-06 - Investigation of Safety, Efficacy and Pharmacokinetics of Fosphenytoin
Lead Sponsor:
Nobelpharma
Conditions:
Epilepsy
Eligibility:
All Genders
2+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- male or female, hospitalized patients 2 years of age or older
- Adult patients or guardian for pediatric patients to provide written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00908453
Start Date
May 1 2009
End Date
February 1 2010
Last Update
May 24 2010
Active Locations (1)
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1
National Center of Neurology and Psychiatry
Kodaira, Tokyo, Japan, 187-8551