NCT00753493

Pharmacokinetics and Safety of Intravenous Topiramate in Adult Patients

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsy
• Migraines

Interventions

Type	Name	Description
DRUG	intravenous topiramate	Single 25 mg IV dose given in addition to subject's normal morning dose of topiramate

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2008-09-16
• Last updated: 2019-07-18

Locations

1 site across 1 country: United States