A Comparison of the Efficacy and Safety of Topiramate Versus Placebo in Preventing Migraine Headaches in Children
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||A Comparison of the Efficacy and Safety of Topiramate Versus Placebo for the Prophylaxis of Migraine in Pediatric Subjects|
- Number of migraine days per month (28 days) during the double-blind treatment period relative to the prospective baseline period.
- Monthly rates of migraine episodes, non-migraine headache episodes, and total headache days; percentage of treatment responders; severity and duration of migraines; frequency and severity of associated migraine symptoms, and use of rescue medicines.
|Study Start Date:||July 2001|
|Study Completion Date:||September 2003|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00237302
|Study Director:||Ortho McNeil Neurologics, Inc. Clinical Trial||Ortho-McNeil Neurologics, Inc.|