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

This study has been completed.
Sponsor:
Information provided by:
Ortho-McNeil Neurologics, Inc.
ClinicalTrials.gov Identifier:
NCT00237302
First received: October 7, 2005
Last updated: May 17, 2011
Last verified: April 2010
  Purpose

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


Condition Intervention Phase
Migraine
Drug: topiramate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Comparison of the Efficacy and Safety of Topiramate Versus Placebo for the Prophylaxis of Migraine in Pediatric Subjects

Resource links provided by NLM:


Further study details as provided by Ortho-McNeil Neurologics, Inc.:

Primary Outcome Measures:
  • Number of migraine days per month (28 days) during the double-blind treatment period relative to the prospective baseline period.

Secondary Outcome Measures:
  • 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.

Enrollment: 162
Study Start Date: July 2001
Study Completion Date: September 2003
Detailed 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).

  Eligibility

Ages Eligible for Study:   6 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00237302

Sponsors and Collaborators
Ortho-McNeil Neurologics, Inc.
Investigators
Study Director: Ortho McNeil Neurologics, Inc. Clinical Trial Ortho-McNeil Neurologics, Inc.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00237302     History of Changes
Other Study ID Numbers: CR002662
Study First Received: October 7, 2005
Last Updated: May 17, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Ortho-McNeil Neurologics, Inc.:
pediatric migraine
migraine headache
migraine prophylaxis
migraine prevention
migraine

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Topiramate
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents

ClinicalTrials.gov processed this record on August 28, 2014