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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:  1-24 months
 
Study #:  1
 
Study Type:  Pharmacokinetic/Tolerability
 
Study Design:  Open label/Population Pharmacokinetic
 
No Patients:  55
 
BPCA(B), PREA(P):  B
 
Asian:  0
 
Black:  4
 
Other:  8
 
White:  43
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  0
 
Non-Hispanic/Non Latino:  0
 
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