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CONCERTA(R) in the Classroom: New Data on Attention in Children With ADHD
Date:11/4/2009

cts quickly and lasts through the day, providing treatment coverage when a child may need it in the early morning, through the activities of the day and into the early evening hours."

The results presented today showed significant improvements in attention with CONCERTA® versus placebo as measured by a validated, time-sensitive math test administered throughout the day.

At one hour post-dose, subjects who received CONCERTA® attempted 38 percent more math problems compared with baseline (from 75.8 problems attempted before treatment to 104.4 problems attempted after treatment), while those receiving placebo showed no change from baseline (from 80.6 problems attempted before treatment to 80 problems attempted after treatment).

The results were statistically significant throughout the study's interim time points, from the first testing point at one hour after dosing (p<0.0001) through to the final assessment at 12.5 hours (p<0.0001). Accuracy, as measured by percentage of problems correct, was similar for both treatment groups and was consistent across the period of observation (placebo, 92.1 percent to 93.5 percent and CONCERTA®, 94.0 percent to 94.3 percent).

Adverse events in the study were consistent with those previously reported for CONCERTA®. Adverse events reported by 5 percent or more of the patients during the study included decreased appetite, abdominal pain, headache, irritability, initial insomnia, nasal congestion, pyrexia and dizziness. No subject discontinued because of adverse events, and no serious adverse events or deaths were reported.

*Matthew Brams, M.D., is a paid consultant and speaker for McNeil Pediatrics(TM), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

About the Poster

This is the first data set from two randomized, double-blind, placebo-controlled, crossover analog simulated-classroom trials examining CONCERTA&#
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SOURCE McNeil Pediatrics(TM)
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