Pharmacokinetics and Safety of Intravenous Topiramate in Adult Patients

NCT ID: NCT00753493

Last Updated: 2019-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Epilepsy Migraines

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

This is a one arm pharmacokinetic and safety study.

Group Type EXPERIMENTAL

intravenous topiramate

Intervention Type DRUG

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

Interventions

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intravenous topiramate

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

Intervention Type DRUG

Other Intervention Names

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Topamax

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James C Cloyd, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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0804M29861

Identifier Type: -

Identifier Source: org_study_id

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