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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  01/29/2010
 
Trade Name:  Lamictal XR
 
Generic or Proper Name (*):  lamotrigine
 
Indications Studied:  Adjunctive therapy for Primary Generalized Tonic-Clonic seizures
 
Therapeutic Category:  Anticonvulsant
 
Ages Studied:  13 years and older
 
Study #:  1
 
Study Type:  Efficacy/Safety/Pharmacokinetic
 
Study Design:  Single-Blind/Parallel Group
 
No Patients:  19
 
No Centers:  51
 
No Countries:  10
 
BPCA(B), PREA(P):  P
 
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