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REFOCUS: Research Study for NWP09 Chewable Tablet Use in Children With ADHD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01654250
First received: April 27, 2012
Last updated: April 2, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacy and safety of NWP09, an extended-release, once-daily chewable tablet formulation of methylphenidate in the treatment of children with ADHD.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder (ADHD)
 Drug: NWP09
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
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:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Average of seven (7) SKAMP-Combined (Swanson, Kotkin, Alger, M-Flynn, Pelham) Rating Scale scores collected at 7 time points during a single day [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    SKAMP is a 13-item rating scale that evaluates classroom behavior (7 items for Attention, and 6 items for Deportment). Answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 78.


Enrollment: 90
Study Start Date: July 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NWP09
once-daily chewable tablet
 Drug: NWP09
Methylphenidate HCl extended-release chewable tablets
Placebo Comparator: Placebo
once-daily chewable tablet
 Drug: placebo
placebo chewable tablets

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ADHD
  • In need of pharmacological treatment for ADHD

Exclusion Criteria:

  • Other psychiatric diagnoses
  • Significant cognitive impairment
  • Chronic medical illnesses
  • Structural cardiac defects
  • Significant abnormal lab tests
  • Taking disallowed medications
  • Positive drug test
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01654250

Locations
United States, Arkansas
Clinical Study Centers
Little Rock, Arkansas, United States, 72211
United States, California
UC-Irvine - Child Development Center
Irvine, California, United States, 92612
United States, Florida
Florida Clinical Research Center, LLC
Bradenton, Florida, United States, 34201
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: Richard Mamelok, MD Pfizer
  More Information

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01654250     History of Changes
Other Study ID Numbers: NWP09-ADHD-300
Study First Received: April 27, 2012
Last Updated: April 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
ADHD

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

ClinicalTrials.gov processed this record on May 23, 2013