The Effectiveness and Safety of Topiramate on Prevention of Chronic Migraine

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 3

Conditions

Migraine

Treatments

Drug: topiramate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00216606

CR003928

Details and patient eligibility

About

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.

Full 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-week period in which each patient's dose is adjusted and then kept stable for the last 4 weeks of the 16-week double-blind phase. The individualized dose will start at 25 milligrams of topiramate per day and will be increased 25 milligrams per day once weekly and then raised to either the target--100 milligrams per day--or the maximum dose that is well tolerated up to 200 milligrams per day. Patients who are randomized to receive topiramate will remain on the optimized dose. The comparison phase of the study is a 16-week period in which the change in migraine days of patients on topiramate (taking at least 50 milligrams per day) is compared with the change in migraine days for patients on the placebo. Also studied will be the patients' health-related quality of life as assessed by questionnaires filled out at specific visits as well as the patients' views of the safety and tolerability of topiramate. The study hypothesis is that the number of migraine days, periods, and attacks from the baseline period to the last 4 weeks in the double-blind period is reduced more in the topiramate group than the placebo group. During the 16-week comparison period, patients will take by mouth a dose of 50 milligrams to 200 milligrams of topiramate daily.

Enrollment

59 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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).