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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail

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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