Clinical trial NCT01654250: NWP09 in Children With Attention Deficit Hyperactivity Disorder (ADHD)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
methylphenidate extended-release
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-07-31
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores-Average of All Post-Dose Time-Points
timeFrame: 0.75 up to 13 hours post-dose
Secondary outcomes:
measure: Onset and Duration of Clinical Effect
timeFrame: 0.75, 2, 4, 8, 10, 12, 13 hours post-dose
measure: 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
timeFrame: 0.75, 2, 4, 8, 10, 12, 13 hours post-dose
measure: Permanent Product Measure of Performance (PERMP) Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose
timeFrame: 0.75, 2, 4, 8, 10, 12 and 13 post-dose
Other outcomes:
measure: Clinical Global Impression of Severity (CGI-S)
timeFrame: Baseline, Day 8, 15, 22, 29, 36, 43
measure: Clinical Global Impression-Improvement (CGI-I)
timeFrame: Day 8, 15, 22, 29, 36, 43
measure: Conners Parent Rating Scale (CPRS) Scores
timeFrame: Baseline, Day 8, 15, 22, 29, 36, 43
Locations:
city: Little Rock
country: United States
facility: Clinical Study Centers, LLC
state: Arkansas
city: Huntington Beach
country: United States
facility: Laboratory School
state: California
city: Irvine
country: United States
facility: UC Irvine Child Development Center
state: California
city: Irvine
country: United States
facility: UC Irvine - Hewitt Hall
state: California
city: Bradenton
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Bradenton
country: United States
facility: Woodland Community Church (Laboratory School)
state: Florida
city: Las Vegas
country: United States
facility: Center for Psychiatry and Behavioral Medicine, Inc.
state: Nevada
city: Houston
country: United States
facility: Bayou City Research, Ltd.
state: Texas
city: Lubbock
country: United States
facility: Westex Clinical Investigations
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.