A Study of the Effectiveness and Safety of Topiramate for the Prevention of Migraine Attacks in Children
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|ClinicalTrials.gov Identifier: NCT00210535|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : June 8, 2011
|Condition or disease||Intervention/treatment||Phase|
|Migraine Vascular Headaches||Drug: Topiramate; Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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|
|Study Start Date :||June 2005|
|Actual Study Completion Date :||November 2006|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00210535
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|