Status:
COMPLETED
A Comparison of the Efficacy and Safety of Topiramate Versus Placebo in Preventing Migraine Headaches in Children
Lead Sponsor:
Ortho-McNeil Neurologics, Inc.
Conditions:
Migraine
Eligibility:
All Genders
6-15 years
Phase:
PHASE3
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.
Detailed Description
Pediatric migraine headache is a common cause of severe recurring headaches in children, especially children between the ages of 5 and 15 years. These headaches can be disabling and tend to interfere ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2003
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT00237302
Start Date
July 1 2001
End Date
September 1 2003
Last Update
May 19 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.