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Sponsored by: |
Janssen Pharmaceutica N.V., Belgium |
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Information provided by: | Janssen Pharmaceutica N.V., Belgium |
ClinicalTrials.gov Identifier: | NCT00216606 |
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.
Condition | Intervention | Phase |
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Migraine |
Drug: topiramate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Double-Blind Placebo Controlled Trial to Investigate the Efficacy and Tolerability of Topiramate in the Prophylaxis of Chronic Migraine |
Estimated Enrollment: | 60 |
Study Start Date: | October 2003 |
Estimated Study Completion Date: | July 2005 |
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 milliigrams of topirimate per day and will be increased 25 milligrams per day once weekly and then raised to either the target--100 miligrams 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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR003928 |
Study First Received: | September 13, 2005 |
Last Updated: | October 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00216606 |
Health Authority: | Belgium: Ministry of Social Affairs, Public Health and the Environment |
Topiramate Headache Migraine headache Migraine Chronic migraine |
Migraine Disorders Headache Topiramate Central Nervous System Diseases |
Headache Disorders, Primary Brain Diseases Headache Disorders |
Anti-Obesity Agents Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases Protective Agents |
Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions Anticonvulsants |