Migraine Clinical Trial
Official title:
An Open-label Study of the Safety and Efficacy of Topiramate for Migraine Prophylaxis: Extension Study to CAPSS-277
The purpose of this study is to assess the long-term safety and effectiveness of topiramate for the prevention of migraine headaches in adults. Topiramate has been approved to prevent migraine headaches in adults.
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
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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