NWP09 in Children With Attention Deficit Hyperactivity Disorder (ADHD)

The SKAMP scale measured the manifestations of attention deficit hyperactivity disorder (ADHD) using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score comprised of 13 items (including subscales: attention with items 1-4, deportment with items 5-8, quality of work with items 9-11 and compliance with items 12-13). The SKAMP composite score was obtained by summing up each item score where each item was rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible combined score of 0 to 78; where higher score signified worst impairment. Average of all post dose SKAMP-combined scores measured at 0.75, 2, 4, 8, 10, 12 and 13 hours post-dose was calculated.

Onset and duration of clinical effect was determined using SKAMP combined rating scale at each post-dose time point. Onset of effect was defined as first assessment time showing statistical significance (i.e. p was less than or equal to [=<] 0.05) between NWP09 and placebo and duration of effect was defined as the as last consecutive time-point at which difference was statistically significant between NWP09 and placebo. SKAMP scale measured the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score was comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined score was obtained by summing up each item score where each item was rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment.

SKAMP scale measured the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. The SKAMP subscales were obtained by summing the individual items as follows: Attention (items 1-4) and Deportment (items 5-8), where each item was rated on a 7-point scale (0=normal to 6=maximal impairment). SKAMP attention subscale was reported which evaluates concentration in the classroom and comprises of 4 items, with a total possible score for of 0 to 24; higher score indicates worst impairment. SKAMP deportment subscale was reported which assesses behavior in the classroom and comprises of 4 items, with a total possible score for each sub-scale of 0 to 24; higher score indicates worst impairment.

The PERMP score measured the manifestations of attention deficit hyperactivity disorder. The PERMP is a 10-minute written test, on 80 math problems, performed as seatwork in the classroom. At the end of the 10- minute math test , the PERMP score of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session was used to measure participant's performance. The total score range from 0-160 with higher scores indicating better performance.