Status:
COMPLETED
A Study of the Effectiveness and Safety of Topiramate Versus Placebo for Preventing Chronic Migraine Headaches
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Ortho-McNeil Neurologics, Inc.
Conditions:
Migraine
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the safety and effectiveness of topiramate as compared to placebo for the prevention of headaches in patients with chronic migraine. Topiramate has been approved...
Detailed Description
Migraine headaches can be disabling and can interfere with work and a person's quality of life. Preventing these headaches before they start is the best option. Topiramate, an anti-seizure medication,...
Eligibility Criteria
Inclusion
- Diagnosis of chronic migraine
- \>=15 headache days per month in past 30 days
- \>= 15 headache days, half of which need to be migraine headaches during the prospective baseline period
- MIDAS test score \>= 11 at Visit 1
- In generally good health
- If female, using birth control
- No abnormalities on neurological examination
Exclusion
- Failed \> 2 adequate trials of migraine prevention medications
- Failed topiramate due to lack of effectiveness or adverse events
- Daily headaches of severe intensity during past 30 days
- Cluster, basilar, ophthalmoplegic, or hemiplegic migraines
- Migraines started after age 50
- Other pain greater than migraine pain
- Use of drugs to treat migraines for \> 4 days per week during the past month
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
328 Patients enrolled
Trial Details
Trial ID
NCT00210912
Start Date
September 1 2003
End Date
April 1 2005
Last Update
June 10 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.