Migraine in Pediatric Population (12-17 year olds, inclusive)
Conditions
Interventions
Product Name: Topiramate Tablets 25mg
Product Code: GFI-17021-000-CA-008/FD-17021-AQ
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Topiramate
Current Sponsor code: RWJ-17021-000
Concent
Sponsors
Janssen Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Males and females between 12 and 17 years of age, inclusive, with a history consistent with migraine with or without aura conforming to IHS criteria for pediatric subjects for at least 6 months prior to screening Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Previously failed therapy with topiramate for migraine prophylaxis or discontinued due to adverse events Currently taking topiramate Has mixed headaches and is unable to distinguish migraines from other headache types (Note: Episodic tension or sinus headaches will not be considered exclusionary unless they contribute to the total number of headache days exceeding 14 per month during the 3 months before Visit 1 or during the prospective baseline period.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study are to evaluate the efficacy of 2 dosages of topiramate, 50 and 100 mg/day, compared with placebo in the prevention of migraine attacks in subjects 12 to 17 years of age, as assessed by the percent reduction in the frequency of monthly migraine attacks over the last 12 weeks of the double-blind phase compared with baseline ;Secondary Objective: To evaluate the safety of 2 dosages of topiramate, 50 and 100 mg/day, in subjects 12 to 17 years of age with migraine To document exposure to topiramate by estimating the trough plasma topiramate concentrations To explore the effect of 2 dosages of topiramate, 50 and 100 mg/day, on the physical, emotional, social, home, and school functioning of subjects 12 to 17 years of age with migraine. ;Primary end point(s): The primary efficacy end point (i.e., percent reduction in frequency of monthly [28 day] migraine attack, using the 48-hour rule, from the prospective baseline period to the last 12 weeks of the double-blind phase) will be analyzed using an ANCOVA model and the last-observation-carried-forward (LOCF) method. | — |
Countries
Belgium, Finland, Norway, Spain
Outcome results
None listed