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Pharmacokinetics and Safety of Intravenous Topiramate in Adult Patients

Epilepsy Clinical Trial

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

Clinical Trial 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 Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00753493
Study type Interventional
Source University of Minnesota - Clinical and Translational Science Institute
Contact
Status Completed
Phase Phase 1
Start date August 2008
Completion date August 2010
View Details
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