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Pharmacokinetics and Safety of Intravenous Topiramate in Adult Patients

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ClinicalTrials.gov Identifier: NCT00753493
Recruitment Status : Completed
First Posted : September 16, 2008
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:
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 or disease Intervention/treatment Phase
Epilepsy Migraines Drug: intravenous topiramate Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Pharmacokinetic and Safety Study of Intravenous Topiramate in Adult Patients
Study Start Date : August 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Topiramate

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00753493


Locations
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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: James C Cloyd, PharmD University of Minnesota
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT00753493    
Other Study ID Numbers: 0804M29861
First Posted: September 16, 2008    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Topiramate
Anticonvulsants
Hypoglycemic Agents
Physiological Effects of Drugs