ue (14.2 percent) and sedation (13.3 percent). However, somnolence, sedation and fatigue typically occurred early in the study and most resolved as treatment continued. The incidence of syncopal events was less than 1 percent. In some of the patients who did experience syncope, potential contributing factors were noted (such as dehydration, sudden change in body position, and hot environment). While small changes in average blood pressure and pulse rate occurred, cardiovascular events were uncommon.

For all doses, the mean ADHD-RS-IV total scores and subscale scores showed significant improvement from baseline to endpoint: -18.1 points on the ADHD-RS-IV total; -8.5 points on the ADHD-RS-IV hyperactive/impulsive subscale and -9.5 points on the ADHD-RS-IV inattentive subscale (P <.001).

Similar to the 303 study, the objective of the 305 open-label trial was to assess the long-term safety and efficacy of GXR for the treatment of ADHD in children and adolescents aged 6 to 17 years. During the first month of this study, investigators made weekly adjustments as needed to each participants' once-daily GXR doses from 1 mg to 4 mg for optimal dosing, as defined by 30 percent or more improvement in ADHD-RS-IV total scores.

In this trial, the most commonly reported treatment emergent adverse events greater than 10 percent were somnolence (29.9 percent), headache (19.7 percent), upper respiratory tract infection (15.1 percent), fatigue (12.4 percent) and sedation (11.2 percent). The incidence of syncopal events was less than 2 percent. As in the 303 open-label study, potential contributing factors were noted in some of the patients who did experience syncope. No clinically relevant trends in ECGs, hematologic or laboratory parameters, vital signs, urinalyses, or physical examination were seen.

Interim results from trial 305 showed that for all doses, the mean ADHD-RS-IV total scores showed significant improvement of -21.6 p
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Contact: Marion E. Glick
212-601-8273
Porter Novelli
23-May-2007

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