Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
  • Print
  • Share
  • E-mail
-
 
Approval Date:  05/29/2009
 
Trade Name:  Lamictal XR
 
Generic or Proper Name (*):  lamotrigine
 
Indications Studied:  Adjunctive therapy for partial onset seizures in patients e13 years of age
 
Therapeutic Category:  Anticonvulsant
 
Ages Studied:  13 years and older
 
Study #:  1
 
Study Type:  Efficacy/Safety/Pharmacokinetic/Tolerability
 
Study Design:  Single-Blind/Placebo/Parallel Group/Population Pharmacokinetic
 
No Patients:  9
 
No Centers:  154
 
No Countries:  9
 
BPCA(B), PREA(P):  P
 
-
-