The Study of NPC-06 - Investigation of Safety, Efficacy and Pharmacokinetics of Fosphenytoin
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2009
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 21, 2009
CompletedFirst Posted
Study publicly available on registry
May 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedMay 24, 2010
May 1, 2010
9 months
May 21, 2009
May 21, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of adverse events
8 to 12 days
Secondary Outcomes (1)
frequency and nature of seizures
8 to 12 days
Study Arms (3)
15mg/kg of loading dose
EXPERIMENTAL18mg/kg of loading dose
EXPERIMENTAL22.5mg/kg of loading dose
EXPERIMENTALInterventions
15mg/kg, 18mg/kg or 22.5mg/kg of loading doses of fosphenytoin
Eligibility Criteria
You may qualify if:
- male or female, hospitalized patients 2 years of age or older
- Adult patients or guardian for pediatric patients to provide written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nobelpharmalead
Study Sites (1)
National Center of Neurology and Psychiatry
Kodaira, Tokyo, 187-8551, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Eiji Nakagawa, M.D.
National Center of Neurology and Psychiatry
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 21, 2009
First Posted
May 25, 2009
Study Start
May 1, 2009
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
May 24, 2010
Record last verified: 2010-05