The Study of NPC-06 - Investigation of Safety, Efficacy and Pharmacokinetics of Fosphenytoin
Information source: Nobelpharma
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy
Intervention: fosphenytoin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Nobelpharma Official(s) and/or principal investigator(s): Eiji Nakagawa, M.D., Study Director, Affiliation: National Center of Neurology and Psychiatry
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.
Clinical Details
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Incidence of adverse events
Secondary outcome: frequency and nature of seizures
Eligibility
Minimum age: 2 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
National Center of Neurology and Psychiatry, Kodaira, Tokyo 187-8551, Japan
Additional Information
Starting date: May 2009
Last updated: May 21, 2010
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