Pharmacokinetics and Safety of Intravenous Topiramate in Adult Patients
Information source: University of Minnesota
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy; Migraines
Intervention: intravenous topiramate (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: University of Minnesota Official(s) and/or principal investigator(s):
James C Cloyd, PharmD, Principal Investigator, Affiliation: University of Minnesota
Overall contact:
Annie M Clark, PharmD, Phone: 612-625-2216, Email: clar0097@umn.edu
Summary
The aims of this study are to determine, in adult patients on maintenance topiramate
therapy, the steady-state pharmacokinetics and safety of orally and intravenously
administered topiramate.
Clinical Details
Official title: Phase I Pharmacokinetic and Safety Study of Intravenous Topiramate in Adult Patients
Study design: Treatment, Open Label, Single Group Assignment, Pharmacokinetics Study
Primary outcome: Pharmacokinetics
Detailed description:
The long-term goal of this research project is to develop a more effective, safer therapy
for neonatal seizures. Prior to using an investigational intravenous topiramate formulation
in children and neonates, the pharmacokinetics and safety of the formulation must be
demonstrated in adults. The immediate aims of this study are to determine the
pharmacokinetics and safety of a novel intravenous topiramate formulation. An additional
aim is to determine if sex, advancing age, or genotype affects topiramate absorption,
distribution, or elimination.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Persons taking topiramate
- Persons 18 years of age and older
Exclusion Criteria:
- Patients who are pregnant
- Patients who are breast feeding
- Patients with significant medical problems who may not tolerate intravenous
administration
- Patients taking medications known to affect topiramate disposition
Locations and Contacts
Annie M Clark, PharmD, Phone: 612-625-2216, Email: clar0097@umn.edu
University of Minnesota, Minneapolis, Minnesota 55455, United States; Recruiting
Annie M Clark, PharmD, Phone: 612-625-2216, Email: clar0097@umn.edu
James C Cloyd, PharmD, Phone: 612-624-4609, Email: cloyd001@umn.edu
Additional Information
Starting date: August 2008
Ending date: August 2010
Last updated: March 16, 2009
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