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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 #:  2
Study Type:  Efficacy/Safety
Study Design:  Blind/Open Label
No Patients:  7
No Centers:  38
No Countries:  1