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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail

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Approval Date:  12/22/2009
Trade Name:  Topamax
Generic or Proper Name (*):  topiramate
Indications Studied:  Adjunctive Treatment for Partial Onset Epilepsy in Infants and Toddlers 1 to 24 months
Therapeutic Category:  Anticonvulsant
Ages Studied:  12 years and older
Study #:  1
Study Type:  Efficacy/Safety
Study Design:  Single-Blind/Placebo
No Patients:  141
No Centers:  34
No Countries:  9
Countries:  Argentina, Brazil, Finland, France, Israel, Norway, Romania, Spain, US