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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:
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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