A Comparison of the Efficacy and Safety of Topiramate Versus Placebo in Preventing Migraine Headaches in Children

Ortho-McNeil

Status and phase

Completed

Phase 3

Conditions

Migraine

Treatments

Drug: topiramate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00237302

CR002662

Details and patient eligibility

About

The purpose of this study is to assess the safety and efficacy of topiramate as compared to placebo in preventing migraines in children.

Full description

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).

Enrollment

162 patients

Sex

All

Ages

6 to 15 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Children who have had several attacks of headaches that meet the International Headache Society Classification of pediatric migraine with or without aura (for example, headache lasts up to 48 hours, has a throbbing quality, is accompanied by nausea or sensitivity to light, is made worse by physical activity)
Average of 3 to 10 migraine days per month for previous 3 months
Weighs more than 20 kilograms (44 pounds)
Able to swallow a tablet whole (without crushing it)

Exclusion criteria

Took topiramate previously to prevent migraines but it was not effective
Had to stop taking topiramate because of side effects
Presence of cluster headaches, migraine aura without headache
Had taken any medications for migraine prevention within 2 weeks before study start
Presence of active liver disease or abnormal kidney function