NCT00210821

Brief Summary

The purpose of this study is to compare the effectiveness and safety of two treatment regimens in preventing migraines. The antidepressant amitriptyline has been used successfully to prevent migraine headaches.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
347

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2004

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

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

June 10, 2011

Status Verified

May 1, 2010

First QC Date

September 13, 2005

Last Update Submit

June 8, 2011

Conditions

MigraineHeadache

Keywords

migraineheadacheanalgesicsprophylaxisprevention

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the average monthly migraine episode rate.

Secondary Outcomes (1)

  • Change in average monthly rate of days with migraine headache; change in average monthly rate of headache (migraine & non-migraine) days; change in average monthly rate of acute abortive medications; weight changes; quality of life assessments

Interventions

topiramateDRUG

Eligibility Criteria

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

You may qualify if:

  • Migraine headache for at least 6 months, with 3 to 12 headaches a month for the previous 3 months
  • no more than 15 headache days in the previous month before study start
  • no heart rhythm problems or neurologic problems
  • women must not be pregnant and must use birth control

You may not qualify if:

  • Cannot have failed at least 2 previous trials of migraine prevention drugs
  • cannot have failed a previous trial of topiramate or amitriptyline
  • no cluster headaches
  • no migraine with aura without headache
  • no pain that is worse than the migraine pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Migraine DisordersHeadache

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    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

September 13, 2005

First Posted

September 21, 2005

Study Start

February 1, 2004

Study Completion

November 1, 2005

Last Updated

June 10, 2011

Record last verified: 2010-05