CONCERTA(R) in the Classroom: New Data on Attention in Children... (174; versus placebo. These studies inclu...)

CONCERTA(R) in the Classroom: New Data on Attention in Children With ADHD

Date:11/4/2009

174; versus placebo. These studies include a wide range of endpoints based on standardized ADHD measurements, which were tested in a simulated classroom environment, as well as observational input from subjects' parents, teachers and physicians.

"These studies were designed to assess clinically significant improvements in attention, behavior and cognition using a wide range of measures," said H. Lynn Starr, M.D., Director of Medical Affairs for Ortho-McNeil Janssen Scientific Affairs, LLC, and lead author of the poster. "The data presented today provide new insights for healthcare professionals to consider when choosing a medication for children with ADHD."

The primary endpoint analysis in the data set presented today evaluated the onset and duration of effect of CONCERTA® among a representative population of 78 children with ADHD, using a timed mathematical problem-solving measurement known as Permanent Product Measure of Performance, or PERMP.

PERMP is a validated, time sensitive, skill-adjusted math test designed to evaluate a subject's ability to attend, initiate and complete written seatwork. This test was designed to show increase in productivity or attention to detail but does not assess a child's ability to learn math. This data set reflected two components of the PERMP assessment: math problems attempted (PERMP-A) and completed correctly (PERMP-C) within a series of 10-minute time periods. Assessments were performed 30 minutes before the first dose of CONCERTA® or placebo, and periodically throughout the school day simulated in the study.

In these findings, 9- to-12-year-old children who were previously untreated or sub-optimally treated for ADHD received CONCERTA®, which was increased until an optimal individualized dose was achieved (to a maximum of 54 mg/day) over one to six weeks. Children were treated with the optimal dose or placebo in the two separate days of the double-blind, randomized,
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SOURCE McNeil Pediatrics(TM)
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CONCERTA(R) in the Classroom: New Data on Attention in Children...(174; versus placebo. These studies inclu...),Health