NCT00237302

Brief Summary

The purpose of this study is to assess the safety and efficacy of topiramate as compared to placebo in preventing migraines in children.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
162

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2001

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

July 1, 2001

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
Last Updated

May 19, 2011

Status Verified

April 1, 2010

First QC Date

October 7, 2005

Last Update Submit

May 17, 2011

Conditions

Migraine

Keywords

pediatric migrainemigraine headachemigraine prophylaxismigraine preventionmigraine

Outcome Measures

Primary Outcomes (1)

  • Number of migraine days per month (28 days) during the double-blind treatment period relative to the prospective baseline period.

Secondary Outcomes (1)

  • Monthly rates of migraine episodes, non-migraine headache episodes, and total headache days; percentage of treatment responders; severity and duration of migraines; frequency and severity of associated migraine symptoms, and use of rescue medicines.

Interventions

topiramateDRUG

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children who have had several attacks of headaches that meet the International Headache Society Classification of pediatric migraine with or without aura (for example, headache lasts up to 48 hours, has a throbbing quality, is accompanied by nausea or sensitivity to light, is made worse by physical activity)
  • Average of 3 to 10 migraine days per month for previous 3 months
  • Weighs more than 20 kilograms (44 pounds)
  • Able to swallow a tablet whole (without crushing it)

You may not qualify if:

  • Took topiramate previously to prevent migraines but it was not effective
  • Had to stop taking topiramate because of side effects
  • Presence of cluster headaches, migraine aura without headache
  • Had taken any medications for migraine prevention within 2 weeks before study start
  • Presence of active liver disease or abnormal kidney function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Migraine Disorders

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • Ortho McNeil Neurologics, Inc. Clinical Trial

    Ortho-McNeil Neurologics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 7, 2005

First Posted

October 12, 2005

Study Start

July 1, 2001

Study Completion

September 1, 2003

Last Updated

May 19, 2011

Record last verified: 2010-04