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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  05/08/2009
 
Trade Name:  Lamictal
 
Generic or Proper Name (*):  lamotrigine
 
Indications Studied:  Adjunctive treatment for partial seizures in pediatric patients 1  24 months
 
Therapeutic Category:  Anticonvulsant
 
Ages Studied:  1-24 months
 
Study #:  1
 
Study Type:  Efficacy/Safety/Pharmacokinetic
 
Study Design:  Single-Blind/Placebo
 
No Patients:  177
 
No Centers:  14
 
No Countries:  14
 
BPCA(B), PREA(P):  B
 
Asian:  2
 
Black:  13
 
Other:  4
 
White:  149
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  9
 
Non-Hispanic/Non Latino:  0
 
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