NWP09 in Children With Attention Deficit Hyperactivity Disorder (ADHD)
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
2 other identifiers
interventional
90
1 country
9
Brief Summary
The safety and efficacy of a chewable formulation of extended-release methylphenidate will be studied in children with ADHD
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2012
Shorter than P25 for phase_3
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedFirst Posted
Study publicly available on registry
July 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedResults Posted
Study results publicly available
February 3, 2016
CompletedFebruary 3, 2016
January 1, 2016
3 months
April 27, 2012
January 4, 2016
January 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores-Average of All Post-Dose Time-Points
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.
0.75 up to 13 hours post-dose
Secondary Outcomes (3)
Onset and Duration of Clinical Effect
0.75, 2, 4, 8, 10, 12, 13 hours 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
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
Other Outcomes (3)
Clinical Global Impression of Severity (CGI-S)
Baseline, Day 8, 15, 22, 29, 36, 43
Clinical Global Impression-Improvement (CGI-I)
Day 8, 15, 22, 29, 36, 43
Conners Parent Rating Scale (CPRS) Scores
Baseline, Day 8, 15, 22, 29, 36, 43
Study Arms (2)
Active
EXPERIMENTALNWP09
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Children aged 6 to 12 years with ADHD who require pharmacologic treatment for this condition
You may not qualify if:
- Other serious illnesses or conditions that would put the patient at particular risk for safety events or would interfere with treatment/assessment of ADHD
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (9)
Clinical Study Centers, LLC
Little Rock, Arkansas, 72211, United States
Laboratory School
Huntington Beach, California, 92646, United States
UC Irvine Child Development Center
Irvine, California, 92612, United States
UC Irvine - Hewitt Hall
Irvine, California, 92697, United States
Florida Clinical Research Center, LLC
Bradenton, Florida, 34201, United States
Woodland Community Church (Laboratory School)
Bradenton, Florida, 34202, United States
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, 89128, United States
Bayou City Research, Ltd.
Houston, Texas, 77007, United States
Westex Clinical Investigations
Lubbock, Texas, 79423, United States
Related Publications (1)
Wigal SB, Childress A, Berry SA, Belden H, Walters F, Chappell P, Sherman N, Orazem J, Palumbo D. Efficacy and Safety of a Chewable Methylphenidate Extended-Release Tablet in Children with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2017 Oct;27(8):690-699. doi: 10.1089/cap.2016.0177. Epub 2017 May 30.
PMID: 28557548DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2012
First Posted
July 31, 2012
Study Start
July 1, 2012
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
February 3, 2016
Results First Posted
February 3, 2016
Record last verified: 2016-01