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: November 5, 2013
Last verified: November 2013
  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
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:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Clinical Global Impression - Improvement (CGI-I) at X Months [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • Mean Clinical Global Impression - Severity (CGI-S) score [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • SKAMP-combined [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PERM-P [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Conners Parent rating Scale [ Time Frame: 2 days ] [ Designated as safety issue: No ]

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:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01654250     History of Changes
Other Study ID Numbers: NWP09-ADHD-300, B7491005
Study First Received: April 27, 2012
Last Updated: November 5, 2013
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
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on August 19, 2014