Pharmacokinetics and Safety of Intravenous Topiramate in Adult Patients



Status:Completed
Conditions:Migraine Headaches, Neurology, Epilepsy
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - Any
Updated:11/8/2017
Start Date:August 2008
End Date:August 2010

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Trial Summary
Trial Overview
Inclusion Criteria

Phase I Pharmacokinetic and Safety Study of Intravenous Topiramate in Adult Patients

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.

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.

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
We found this trial at
1
site
Univ of Minnesota
Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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