The Study of NPC-06 - Investigation of Safety, Efficacy and Pharmacokinetics of Fosphenytoin
Information source: Nobelpharma
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy
Intervention: fosphenytoin (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Nobelpharma Official(s) and/or principal investigator(s):
Eiji Nakagawa, M.D., Study Director, Affiliation: National Center of Neurology and Psychiatry
Overall contact:
Kenji Shimizu, Phone: +81-3-5651-1206, Email: shimizu@nobelpharma.co.jp
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: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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
Kenji Shimizu, Phone: +81-3-5651-1206, Email: shimizu@nobelpharma.co.jp
National Center of Neurology and Psychiatry, Kodaira, Tokyo 187-8551, Japan; Recruiting
Nakagawa, Email: nakagawa@ncnp.go.jp
Additional Information
Starting date: May 2009
Ending date: December 2009
Last updated: May 22, 2009
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