Pharmacokinetics and Safety of Intravenous Topiramate in Adult Patients

University of Minnesota (UMN)

Status and phase: Completed; Phase 1

Conditions: Epilepsy; Migraines

Treatments: Drug: intravenous topiramate

Study type: Interventional

Funder types: Other

Identifiers

NCT00753493

0804M29861

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

1

Experimental group

Description:

This is a one arm pharmacokinetic and safety study.

Treatment:

Drug: intravenous topiramate