Epilepsy, Migraines
Conditions
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.
Interventions
DRUGintravenous topiramate
Single 25 mg IV dose given in addition to subject's normal morning dose of topiramate
Sponsors
University of Minnesota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety as measured by the occurrence of adverse events | 96 hours after dosing | Occurrence of adverse events in the 4 days following Topiramate dose |
Countries
United States
Outcome results
None listed