An Open Label Extension of a Study Comparing Topiramate and Amitriptyline in Migraine Prevention.
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|ClinicalTrials.gov Identifier: NCT00210860|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : June 10, 2011
|Condition or disease||Intervention/treatment||Phase|
|Migraine||Drug: topiramate||Phase 3|
Migraine headaches can be disabling and can interfere with work and a person's quality of life. Preventing these headaches before they start is the best option. Topiramate, an anti-seizure medication, has been shown to help prevent migraine headaches from occurring. This is an open-label study that is an extension of a previous study (CAPSS-277) comparing topiramate and amitriptyline in migraine prevention. It includes patients who completed the previous study and elected to enter open label treatment with topiramate. The study will involve a 4-week Blinded Transition Phase during which patients will be titrated up to a daily topiramate dose of 100 milligrams (or the maximum tolerated dose, whichever is less). Then there will be a 12-week Open-Label Maintenance Phase during which the topiramate dose may be adjusted according to effectiveness and tolerance, but not to exceed a daily dose of 400 milligrams. While on topiramate, patients will record daily entries in their headache records. Patients will be asked questions to help assess their quality of life. Patients will also have physical examinations and laboratory tests performed during the study. The objective of this study is to evaluate the long-term safety and effectiveness of topiramate for the prevention of migraine headaches.
Topiramate oral tablets, 25 milligrams per tablet, will be given in the morning and evening to a dose not to exceed 400 milligrams per day or to the maximum tolerated dose, whichever is less
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||142 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Study of the Safety and Efficacy of Topiramate for Migraine Prophylaxis: Extension Study to CAPSS-277|
|Study Start Date :||September 2004|
|Actual Study Completion Date :||March 2006|
- Patient diary: number, duration, severity of headaches, symptoms, other medications used; QOL: Migraine Disability Assessment, Migraine-Specific Quality of Life, Quality of Life Enjoyment & Satisfaction Questionnaire-Short Form, Weight Satisfaction Scale
- Adverse event reports; physical examinations; vital signs; electrocardiogram; laboratory tests for safety
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00210860
|Study Director:||Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|