Back to resultsThe Study of NPC-06 - Investigation of Safety, Efficacy and Pharmacokinetics of Fosphenytoin
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
fosphenytoin
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring NPC-06, fosphenytoin, phenytoin, pharmacokinetics, safety
Eligibility 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
Sites / Locations
- National Center of Neurology and Psychiatry
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
15mg/kg of loading dose
18mg/kg of loading dose
22.5mg/kg of loading dose
Arm Description
Outcomes
Primary Outcome Measures
Incidence of adverse events
Secondary Outcome Measures
frequency and nature of seizures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00908453
Brief Title
The Study of NPC-06 - Investigation of Safety, Efficacy and Pharmacokinetics of Fosphenytoin
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Nobelpharma
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
NPC-06, fosphenytoin, phenytoin, pharmacokinetics, safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
15mg/kg of loading dose
Arm Type
Experimental
Arm Title
18mg/kg of loading dose
Arm Type
Experimental
Arm Title
22.5mg/kg of loading dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
fosphenytoin
Intervention Description
15mg/kg, 18mg/kg or 22.5mg/kg of loading doses of fosphenytoin
Primary Outcome Measure Information:
Title
Incidence of adverse events
Time Frame
8 to 12 days
Secondary Outcome Measure Information:
Title
frequency and nature of seizures
Time Frame
8 to 12 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eiji Nakagawa, M.D.
Organizational Affiliation
National Center of Neurology and Psychiatry
Official's Role
Study Director
Facility Information:
Facility Name
National Center of Neurology and Psychiatry
City
Kodaira
State/Province
Tokyo
ZIP/Postal Code
187-8551
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
The Study of NPC-06 - Investigation of Safety, Efficacy and Pharmacokinetics of Fosphenytoin
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