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Pharmacokinetics and Safety of Intravenous Topiramate in Adult Patients

Primary Purpose

Epilepsy, Migraines

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

intravenous topiramate

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Minnesota

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

This is a one arm pharmacokinetic and safety study.

Outcomes

Primary Outcome Measures

Safety as measured by the occurrence of adverse events

Occurrence of adverse events in the 4 days following Topiramate dose

Secondary Outcome Measures

Full Information

NCT ID

NCT00753493

First Posted

September 12, 2008

Last Updated

July 15, 2019

Sponsor

University of Minnesota

1. Study Identification

Unique Protocol Identification Number

NCT00753493

Brief Title

Pharmacokinetics and Safety of Intravenous Topiramate in Adult Patients

Official Title

Phase I Pharmacokinetic and Safety Study of Intravenous Topiramate in Adult Patients

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Minnesota

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epilepsy, Migraines

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

This is a one arm pharmacokinetic and safety study.

Intervention Type

Drug

Intervention Name(s)

intravenous topiramate

Other Intervention Name(s)

Topamax

Intervention Description

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

Primary Outcome Measure Information:

Title

Safety as measured by the occurrence of adverse events

Description

Occurrence of adverse events in the 4 days following Topiramate dose

Time Frame

96 hours after dosing

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James C Cloyd, PharmD

Organizational Affiliation

University of Minnesota

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Minnesota

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Pharmacokinetics and Safety of Intravenous Topiramate in Adult Patients

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