A Multicenter, Dose-optimized, Double-blind, Randomized, Placebo-controlled Study To Evaluate The Efficacy Of Nwp09 In Pediatric Patients With Attention Deficit Hyperactivity Disorder (Adhd) In A Laboratory Classroom
Overview
- Phase
- Phase 3
- Intervention
- NWP09
- Conditions
- Attention Deficit Hyperactivity Disorder
- Sponsor
- Pfizer
- Enrollment
- 90
- Locations
- 9
- Primary Endpoint
- Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores-Average of All Post-Dose Time-Points
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The safety and efficacy of a chewable formulation of extended-release methylphenidate will be studied in children with ADHD
Investigators
Eligibility Criteria
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
Arms & Interventions
Active
NWP09
Intervention: NWP09
Placebo
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores-Average of All Post-Dose Time-Points
Time Frame: 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 Outcomes
- Onset and Duration of Clinical Effect(0.75, 2, 4, 8, 10, 12, 13 hours post-dose)
- 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)
- 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)