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Pediatric Studies Characteristics - Detail
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Pediatrics
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 #:
2
Study Type:
Safety/Pharmacokinetic/Tolerability
Study Design:
Open Label
No Patients:
284
No Centers:
74
No Countries:
25
BPCA(B), PREA(P):
B
Asian:
0
Black:
14
Other:
94
White:
176
Native Hawaiian or Pacific Islander:
0
American Indian/Alaska Native:
0
Hispanic/Latino:
0
Non-Hispanic/Non Latino:
0
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