Status:
COMPLETED
The Effectiveness and Safety of Topiramate on Prevention of Chronic Migraine
Lead Sponsor:
Janssen Pharmaceutica N.V., Belgium
Conditions:
Migraine
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of individualized doses (50 to 200 milligrams) of topiramate tablets compared against placebo for the prevention of chronic migrai...
Detailed Description
Previous studies have shown that topiramate is effective in preventing chronic migraine headaches. This study will start with a 4-week baseline period in which no treatment is given, followed by a 12-...
Eligibility Criteria
Inclusion
- History of migraine for \>= 1 year
- Headache type meets HIS (International Headache Society) criteria for migraine
- History reflects "chronic" headache--an average of \>= 15 migraine days per month in the 3 months preceding trial entry
- History of chronic migraine for \>=1 year\>=15 headaches per month with an average duration of 4 hours if not treated
- Patient is otherwise neurologically and physically healthy on a pre-trial exam.
Exclusion
- Any other type of chronic headache (besides migraine) from section 2 to 13 of the International Headache Society classification or headache resulting directly resulting some other factor (except for medication overuse)
- Onset of migraine after age 50
- Use of an anticonvulsant drug in the month prior to trial entry
- Use of an antidepressant unless dose has been used at a stable dose for \>=3 months
- Use of migraine prevention medicine in the 3 months prior to trial entry unless the drug has been used for at least 3 months and used at a stable dose for at least a month
- Use of a carbonic anhydrase inhibitor such as acetazolamide (used to treat high blood pressure, glaucoma and seizures) or triamterene (a "water pill" for swelling and high blood pressure).
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00216606
Start Date
December 1 2003
End Date
July 1 2005
Last Update
February 1 2011
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