Pharmacokinetics and Safety of Intravenous Topiramate in Adult Patients

University of Minnesota20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Epilepsy Migraines

Interventions

intravenous topiramateDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Safety as measured by the occurrence of adverse events

Occurrence of adverse events in the 4 days following Topiramate dose

Time frame: 96 hours after dosing

Data from ClinicalTrials.gov

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