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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  04/25/2011
 
Trade Name:  Lamictal XR
 
Generic or Proper Name (*):  lamotrigine
 
Indications Studied:  Monotherapy in patients 13 years of age and older with partial seizures who are receiving therapy with a single antiepileptic drug (AED)
 
Therapeutic Category:  Anticonvulsant
 
Ages Studied:  13 years and older
 
Study #:  1
 
Study Type:  Efficacy/Safety
 
Study Design:  Blind/Open Label
 
No Patients:  17
 
No Centers:  65
 
No Countries:  7
 
BPCA(B), PREA(P):  P
 
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