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 - Pediatric Migraine Prophylaxis

Phase 1

• Conditions: Migraine in Pediatric Population (12-17 year olds, inclusive)

• Registration Number: EUCTR2005-001234-32-FI
• Lead Sponsor: Janssen Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-07-11
• Study Completion: 2006-11-29
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 102

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

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.)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified