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Sponsored by: |
Janssen Cilag Pharmaceutica S.A.C.I., Greece |
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Information provided by: | Janssen Cilag Pharmaceutica S.A.C.I., Greece |
ClinicalTrials.gov Identifier: | NCT00297336 |
A 6-month, observational, post authorization safety study for the collection and evaluation of safety data on topiramate as a prophylactic treatment for migraines in adult patients.
Condition | Intervention | Phase |
---|---|---|
Migraine |
Drug: topiramate |
Phase IV |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | An Open-Label Observational Safety Study During Administration of Topamac, for the Prophylaxis of Migraine |
Estimated Enrollment: | 80 |
Study Start Date: | March 2005 |
Study Completion Date: | February 2007 |
Previous studies have shown that topiramate is effective in preventing migraine headaches. This is a 6-month observational study to evaluate the safety of topiramate in the prevention of migraine in adult patients. The study duration is 6-months, with 5 study visits during the study. The dosage of topiramate should then be increased at 1-week intervals by increments of 25 mg daily. If the patient is unable to tolerate the individualized regimen, longer intervals between doses increments may be used. The recommended total daily dose of topiramate treatment for the prevention of migraine is 100mg daily administered in two divided doses. Some patients may benefit from the total daily dose of 50mg daily. There are patients who received a total daily dose of up to 200mg daily. Dose and individualization rate should be determined by the clinical outcome. The primary objective of this study is the collection and evaluation of data on the safety of topiramate in the prevention of migraine in adult patients over 6 months.
Topiramate will be administered according to the physician's prescription; dose and individualization rate (rate at which the dose of topiramate would be increased) will be determined by the clinical outcome.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR002116 |
Study First Received: | February 24, 2006 |
Last Updated: | March 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00297336 |
Health Authority: | Greece: Hellenic Republic Ministry Of Health And Welfare National Organization For Medicines |
chronic headache Topiramate 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 |