A Study of the Effectiveness and Safety of Topiramate for the Prevention of Migraine Attacks in Children

June 6, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Topiramate for the Prophylaxis of Migraine in Pediatric Subjects 12 to 17 Years of Age

The primary purpose of this study is to evaluate the effectiveness and safety of topiramate compared with placebo in the prevention of migraine attacks in children (12 to 17 years of age).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an outpatient, randomized, double-blind, placebo-controlled study to evaluate the effectiveness of 2 dosages of topiramate (50 and 100 milligrams/day) compared with placebo in the prevention of migraine attacks in children 12 to 17 years of age. The study is composed of 3 phases: pretreatment, double-blind treatment for 4 months (16 weeks), and posttreatment. During the study, patients will maintain headache and medication records to document the following: occurrence and duration of headaches; severity of headache pain; whether or not the headache is pulsating or aggravated by physical activity; associated symptoms, such as nausea, vomiting, photophobia, phonophobia, abdominal pain; and medication taken to relieve headache pain or symptoms. Assessment of efficacy include the percent reduction in the frequency of monthly migraine attacks over the last 12 weeks of the double-blind treatment phase compared with prospective BL period. In addition, the percent reduction in (a) average monthly migraine days, (b) average monthly headache days, and (c) monthly migraine rate, over the last 12 weeks of the double-blind treatment phase compared with the pretreatment phase will be assessed. Safety assessments include the incidence of adverse events, measurement of vital signs (pulse, blood pressure, oral temperature), results of pregnancy tests, physical and neurologic examinations, clinical laboratory tests (hematology, biochemistry, and urinalysis), and monitoring for visual or ocular disturbances, heat intolerance, renal or urinary disturbance, depression and rash. The study hypothesis is that the percent reduction in frequency of monthly (28-day) migraine attacks (using the 48-hour rule) from the prospective baseline period (pretreatment phase) to the last 12 weeks of the double-blind phase will be significantly better for the topiramate groups than for the placebo group. Topiramate tablets (25 milligrams) or placebo, beginning at 25mg once daily (Week 1), increasing to twice daily total of 50mg or 100mg (Week 4). Maximum dosage of topiramate (or placebo) continues for next 12 weeks. Dosage may be reduced once at investigator's discretion.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • History of migraine (with or without aura) conforming to International Headache Society (IHS) criteria for pediatric subjects for >=6 months prior to screening
  • Requires migraine prophylactic therapy, and if previously treated to prevent attacks, had unsatisfactory response to therapy
  • Experienced an average of 3 to 12 migraine attacks and no more than 14 headache days per month during the 3 months prior to the study
  • Females must be sexually abstinent, surgically sterile, or using adequate contraceptive measures, and have negative pregnancy tests before and during the study

Exclusion Criteria:

  • Currently taking or previously unable to tolerate topiramate, or previously failed therapy with topiramate for migraine prophylaxis
  • Has mixed headaches and is unable to distinguish migraines from other headache types
  • Overuses pain medications or specific agents for abortive treatment of migraine attacks
  • Has a body mass index (BMI) greater than 40 or weighs more than 200 pounds, or is markedly underweight (below 5th percentile) for his or her age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Percent reduction in the frequency of monthly migraine attacks (using 48-hour rule) over the last 12 weeks of the double-blind treatment phase compared with the 4-week prospective baseline period.

Secondary Outcome Measures

Outcome Measure
Percent reduction in (a) average monthly migraine days, (b) average monthly headache days, and (c) monthly migraine rate, over the last 12 weeks of the double-blind treatment phase compared with the prospective baseline period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

June 8, 2011

Last Update Submitted That Met QC Criteria

June 6, 2011

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR002245

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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