NCT00753493

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2008

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 12, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

July 18, 2019

Status Verified

July 1, 2019

Enrollment Period

2 years

First QC Date

September 12, 2008

Last Update Submit

July 15, 2019

Conditions

EpilepsyMigraines

Outcome Measures

Primary Outcomes (1)

  • Safety as measured by the occurrence of adverse events

    Occurrence of adverse events in the 4 days following Topiramate dose

    96 hours after dosing

Study Arms (1)

1

EXPERIMENTAL

This is a one arm pharmacokinetic and safety study.

Drug: intravenous topiramate

Interventions

intravenous topiramateDRUG

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

Also known as: Topamax
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Persons taking topiramate
  • Persons 18 years of age and older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

EpilepsyMigraine Disorders

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesHeadache Disorders, PrimaryHeadache Disorders

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • James C Cloyd, PharmD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2008

First Posted

September 16, 2008

Study Start

August 1, 2008

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

July 18, 2019

Record last verified: 2019-07

Locations

US(1)