The Effectiveness and Safety of Topiramate on Prevention of Chronic Migraine

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

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 migraine headaches over a period of 16 weeks.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Pharmaceutica N.V., Belgium
• Treatments: Topiramate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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).