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Pharmacokinetics and Safety of Intravenous Topiramate in Adult Patients

Information source: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy; Migraines

Intervention: intravenous topiramate (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: University of Minnesota - Clinical and Translational Science Institute

Official(s) and/or principal investigator(s):
James C Cloyd, PharmD, Principal Investigator, Affiliation: University of Minnesota - Clinical and Translational Science Institute

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: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

University of Minnesota, Minneapolis, Minnesota 55455, United States
Additional Information

Starting date: August 2008
Last updated: July 12, 2012

Page last updated: August 23, 2015

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