Migraine Clinical Trial
Official title:
A Comparison of the Efficacy and Safety of Topiramate Versus Placebo for the Prophylaxis of Migraine in Pediatric Subjects
The purpose of this study is to assess the safety and efficacy of topiramate as compared to placebo in preventing migraines in children.
Pediatric migraine headache is a common cause of severe recurring headaches in children,
especially children between the ages of 5 and 15 years. These headaches can be disabling and
tend to interfere with a child's daily activities, such as going to school or playing with
friends. Because pediatric migraine children tend to be misdiagnosed, they are often not
treated effectively. Topiramate, an anti-seizure medication, has been shown to prevent
migraines in adults, and it has been approved to treat seizures in children as young as 2
years of age as add-on treatment (used with another drug) and also can be used alone
(monotherapy) in children as young as 10 years old. Since topiramate has already been
studied in children, information about its safety in children is available. In this study,
children with migraine headaches will be identified. It is not necessary for the child to
have the migraine aura (having blurry vision; seeing flashing lights) to be included in this
study. This is a randomized, double-blind, placebo-controlled study of Topiramate (or
placebo) given for 4 to 5 months. An optional 3-month open-label extension (topiramate only;
no placebo) will follow. The objective of the study is to demonstrate that topiramate is
effective and safe when used to prevent migraine headaches (with or without aura) in
children. Safety will be assessed throughout the study.
Topiramate sprinkle capsules (or placebo), starting at 15 milligrams per day for 1st week;
increased to 30 milligrams per day for week 2; increased to 50 milligrams (in tablets) per
day in week 3, then adjusted as needed to 2 to 3 milligrams/kilogram/day for the rest of
study (140 days total).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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