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