A Study of the Effectiveness and Safety of Topiramate for the Prevention of Migraine Attacks in Children
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
1 other identifier
interventional
110
0 countries
N/A
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2005
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedJune 8, 2011
January 1, 2010
September 13, 2005
June 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
June 1, 2005
Study Completion
November 1, 2006
Last Updated
June 8, 2011
Record last verified: 2010-01