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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

September 12, 2008
July 12, 2012
August 2008
August 2010   (final data collection date for primary outcome measure)
Pharmacokinetics [ Time Frame: 96 hours after dosing ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00753493 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Pharmacokinetics and Safety of Intravenous Topiramate in Adult Patients
Phase I Pharmacokinetic and Safety Study 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.

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.

Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Epilepsy
  • Migraines
Drug: intravenous topiramate
Single 25 mg IV dose given in addition to subject's normal morning dose of topiramate
Other Name: Topamax
Experimental: 1
This is a one arm pharmacokinetic and safety study.
Intervention: Drug: intravenous topiramate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00753493
0804M29861
Yes
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
Not Provided
Principal Investigator: James C Cloyd, PharmD University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP