The Study of NPC-06 - Investigation of Safety, Efficacy and Pharmacokinetics of Fosphenytoin
- Registration Number
- NCT00908453
- Lead Sponsor
- Nobelpharma
- 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 loading dose of phenytoin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 15mg/kg of loading dose fosphenytoin - 22.5mg/kg of loading dose fosphenytoin - 18mg/kg of loading dose fosphenytoin -
- Primary Outcome Measures
Name Time Method Incidence of adverse events 8 to 12 days
- Secondary Outcome Measures
Name Time Method frequency and nature of seizures 8 to 12 days
Trial Locations
- Locations (1)
National Center of Neurology and Psychiatry
🇯🇵Kodaira, Tokyo, Japan