Pharmacokinetics and Safety of Intravenous Topiramate in Adult Patients - Full Text View

Sponsor:	University of Minnesota - Clinical and Translational Science Institute
Information provided by:	University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:	NCT00753493

Purpose

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.

Condition	Intervention	Phase
Epilepsy Migraines	Drug: intravenous topiramate	Phase I

Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase I Pharmacokinetic and Safety Study of Intravenous Topiramate in Adult Patients

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy Migraine

Drug Information available for: Topiramate

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:

Pharmacokinetics [ Time Frame: 96 hours after dosing ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	August 2008
Study Completion Date:	August 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 This is a one arm pharmacokinetic and safety study.	Drug: intravenous topiramate Single 25 mg IV dose given in addition to subject's normal morning dose of topiramate Other Name: Topamax

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753493

Locations

United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

University of Minnesota - Clinical and Translational Science Institute

Investigators

Principal Investigator:

James C Cloyd, PharmD

University of Minnesota - Clinical and Translational Science Institute

More Information

No publications provided

Responsible Party:	James Cloyd, University of Minnesota
ClinicalTrials.gov Identifier:	NCT00753493 History of Changes
Other Study ID Numbers:	0804M29861
Study First Received:	September 12, 2008
Last Updated:	May 31, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

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

Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents

ClinicalTrials.gov processed this record on February 09, 2012