NWP09 in Children With Attention Deficit Hyperactivity Disorder (ADHD)

Phase 3

Completed

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Drug: Placebo; Drug: NWP09

• Registration Number: NCT01654250
• Lead Sponsor: Pfizer

Brief Summary

The safety and efficacy of a chewable formulation of extended-release methylphenidate will be studied in children with ADHD

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-27
• Study Start: 2012-07
• Study First Submitted QC: 2012-07-26
• Study First Posted: 2012-07-31
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Disposition First Submitted: 2013-11-05
• Disposition First Submitted QC: 2013-11-05
• Disposition First Posted: 2013-11-28
• Status Verified: 2016-01
• Results First Submitted: 2016-01-04
• Results First Submitted QC: 2016-01-04
• Last Update Submitted: 2016-01-04
• Results First Posted: 2016-02-03
• Last Update Posted: 2016-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Children aged 6 to 12 years with ADHD who require pharmacologic treatment for this condition

Exclusion Criteria

• Other serious illnesses or conditions that would put the patient at particular risk for safety events or would interfere with treatment/assessment of ADHD

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Active	NWP09	NWP09

Primary Outcome Measures

Name	Time	Method
Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores-Average of All Post-Dose Time-Points	0.75 up to 13 hours post-dose	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.

Secondary Outcome Measures

Name	Time	Method
Onset and Duration of Clinical Effect	0.75, 2, 4, 8, 10, 12, 13 hours post-dose	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.
Permanent Product Measure of Performance (PERMP) Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose	0.75, 2, 4, 8, 10, 12 and 13 post-dose	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.
Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP) SKAMP Attention and Deportment Subscale Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose	0.75, 2, 4, 8, 10, 12, 13 hours post-dose	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.

Trial Locations

Locations (9)

Westex Clinical Investigations; 🇺🇸 Lubbock, Texas, United States

Laboratory School; 🇺🇸 Huntington Beach, California, United States

Clinical Study Centers, LLC; 🇺🇸 Little Rock, Arkansas, United States

Woodland Community Church (Laboratory School); 🇺🇸 Bradenton, Florida, United States

Florida Clinical Research Center, LLC; 🇺🇸 Bradenton, Florida, United States

UC Irvine Child Development Center; 🇺🇸 Irvine, California, United States

UC Irvine - Hewitt Hall; 🇺🇸 Irvine, California, United States

Center for Psychiatry and Behavioral Medicine, Inc.; 🇺🇸 Las Vegas, Nevada, United States

Bayou City Research, Ltd.; 🇺🇸 Houston, Texas, United States