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 Details — Status: Completed

Administrative data

• NCT number: NCT00753493
• Other study ID #: 0804M29861
• Status: Completed
• Phase: Phase 1
• Start date: August 2008
• Est. completion date: August 2010

Study information

• Verified date: July 2019
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Migraines

Intervention

Drug:
• intravenous topiramate
Single 25 mg IV dose given in addition to subject's normal morning dose of topiramate

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety as measured by the occurrence of adverse events	Occurrence of adverse events in the 4 days following Topiramate dose	96 hours after dosing