Pharmacokinetics and Safety of Intravenous Topiramate in Adult Patients

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Migraines Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intravenous topiramate

Drug

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

Other names: Topamax

Primary outcomes

Safety as measured by the occurrence of adverse events

Time frame: 96 hours after dosing

Occurrence of adverse events in the 4 days following Topiramate dose

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Sep 16, 2008
Registry last updated: Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed