RESEARCH TRIANGLE PARK, NC, August 1, 2006 Data published in today's issue of Pediatrics show that lamotrigine (LAMICTAL) is an effective add-on therapy for the treatment of Primary Generalized Tonic-Clonic (PGTC) seizures in a subgroup of children and adolescents. This is the first published analysis of data from a randomized, double-blind, controlled clinical trial of PGTC seizures focusing on patients 2 to 20 years of age.1C PGTC seizures, also know as "grand mal" seizures, are the most common form of generalized seizures, occurring in approximately 20 percent of patients with epilepsy. Lamictal is not currently indicated for the treatment of PGTC seizures.
"PGTC seizures are more common in children than in adults, and are associated with increased risk of injury or death," said Edwin Trevathan, M.D., M.P.H., Director of the Division of Pediatric and Developmental Neurology at Washington University School of Medicine and Neurologist-in-Chief, St. Louis Children's Hospital, St. Louis, MO, key investigator of the clinical study. "These study findings are important since physicians and neurologists continue to have limited treatment options available for generalized seizures in this age group."
PGTC seizures usually occur without warning and are associated with wide-ranging physical and behavioral changes with potentially life-threatening complications.
Patients who experience PGTC seizures become stiff, lose consciousness, and jerk repetitively. Patients may fall to the ground, bite their tongue, and/or lose bladder control. Serious injury including bone fractures can occur. The seizure will typically last for a few minutes and then be followed by a period of drowsiness, confusion, headache, and sleep. For some people who have this type of seizure, it can take many hours to fully recover.
ABOUT THE STUDY
A randomized, double-blind, placebo-controlled study was conducted to assess the
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Contact: Vanessa Kelepecz
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Cohn & Wolfe
1-Aug-2006