Pharmacokinetics and Safety of Intravenous Topiramate in Adult Patients
- Registration Number
- NCT00753493
- Lead Sponsor
- University of Minnesota
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Persons taking topiramate
- Persons 18 years of age and older
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 intravenous topiramate This is a one arm pharmacokinetic and safety study.
- Primary Outcome Measures
Name Time Method Safety as measured by the occurrence of adverse events 96 hours after dosing Occurrence of adverse events in the 4 days following Topiramate dose
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States