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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
 
BPCA(B), PREA(P):  B
 
Countries:  Argentina, Brazil, Finland, France, Israel, Norway, Romania, Spain, US
 
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