Pharmacokinetics and Safety of Intravenous Topiramate in Adult Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00753493
First received: September 12, 2008
Last updated: July 12, 2012
Last verified: July 2012
  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 1

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:


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 ]

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00753493     History of Changes
Other Study ID Numbers: 0804M29861
Study First Received: September 12, 2008
Last Updated: July 12, 2012
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 August 28, 2014