NWP09 in Children With Attention Deficit Hyperactivity Disorder (ADHD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01654250
First received: April 27, 2012
Last updated: January 4, 2016
Last verified: January 2016
  Purpose
The safety and efficacy of a chewable formulation of extended-release methylphenidate will be studied in children with ADHD

Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Drug: NWP09
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Onset and Duration of Clinical Effect [ Time Frame: 0.75, 2, 4, 8, 10, 12, 13 hours post-dose ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: 0.75, 2, 4, 8, 10, 12, 13 hours post-dose ] [ Designated as safety issue: No ]
    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.

  • Permanent Product Measure of Performance (PERMP) Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose [ Time Frame: 0.75, 2, 4, 8, 10, 12 and 13 post-dose ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Clinical Global Impression of Severity (CGI-S) [ Time Frame: Baseline, Day 8, 15, 22, 29, 36, 43 ] [ Designated as safety issue: No ]
    CGI-S scale was used to measure features associated with ADHD. The assessment was performed by the investigator of the study research team. The CGI-S classified the participant's current disease status as: 1 = normal, not at all ill, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill participants. This outcome measure was analyzed during open label phase in entire study population prior to randomization into two treatment groups.

  • Clinical Global Impression-Improvement (CGI-I) [ Time Frame: Day 8, 15, 22, 29, 36, 43 ] [ Designated as safety issue: No ]
    The CGI-I measured the participant's disease improvement relative to baseline as followed: 1= very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6= much worse, and 7=very much worse. This outcome measure was analyzed during open label phase in entire study population prior to randomization into two treatment groups.

  • Conners Parent Rating Scale (CPRS) Scores [ Time Frame: Baseline, Day 8, 15, 22, 29, 36, 43 ] [ Designated as safety issue: No ]
    CPRS was used to measure features associated with ADHD and was used to compare scores during the dose optimization period i.e. 1-6 weeks. The assessment was performed by parent or guardian. CPRS consisted of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true). Raw scores were converted to t-scores and t-scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. The participant received normalized t-scores on the following scales: oppositional, cognitive problems/inattention, hyperactivity, anxious-shy, perfectionism, social problems, psychosomatic, ADHD index, restless-impulse, emotional liability, conner's global index, inattentive, hyperactive-impulsive and diagnostic and statistical manual of mental disorders IV (DSM-IV). This outcome measure was analyzed during open label phase in entire study population prior to randomization into two treatment groups.


Enrollment: 90
Study Start Date: July 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
NWP09
Drug: NWP09
Methylphenidate, variable dose, daily dosing, 1 week duration
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01654250

Locations
United States, Arkansas
Clinical Study Centers, LLC
Little Rock, Arkansas, United States, 72211
United States, California
Laboratory School
Huntington Beach, California, United States, 92646
UC Irvine - Hewitt Hall
Irvine, California, United States, 92697
UC Irvine Child Development Center
Irvine, California, United States, 92612
United States, Florida
Florida Clinical Research Center, LLC
Bradenton, Florida, United States, 34201
Woodland Community Church (Laboratory School)
Bradenton, Florida, United States, 34202
United States, Nevada
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, United States, 89128
United States, Texas
Bayou City Research, Ltd.
Houston, Texas, United States, 77007
Westex Clinical Investigations
Lubbock, Texas, United States, 79423
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01654250     History of Changes
Other Study ID Numbers: NWP09-ADHD-300  B7491005 
Study First Received: April 27, 2012
Results First Received: January 4, 2016
Last Updated: January 4, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
ADHD
methylphenidate extended-release

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 02, 2016