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A 6-week Study to Evaluate the Safety and Efficacy of Quillichew ERCT in 4-5 Year Old Children With ADHD.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03580005
Recruitment Status : Withdrawn (The study was cancelled prior to the enrollment of any participants.)
First Posted : July 9, 2018
Last Update Posted : November 1, 2018
Information provided by (Responsible Party):

Brief Summary:
A 6-week double-blind study to evaluate the safety and efficacy of Quillichew extended release chewable tablets in 4-5 year old children with attention deficit hyperactivity disorder.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder (ADHD) Attention Deficit Hyperactivity Disorder Drug: methylphenidate HCl ERCT Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 4, Double-blind, Randomized, Parallel Group, Placebo-controlled Study Of The Efficacy And Safety Of Quillichew (Methylphenidate Hydrochloride (Hcl)) Extended Release Chewable Tablets (Erct) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (Adhd)
Estimated Study Start Date : October 31, 2018
Estimated Primary Completion Date : October 12, 2021
Estimated Study Completion Date : October 12, 2021

Arm Intervention/treatment
Active Comparator: Quillichew ERCT
Quillichew ERCT
Drug: methylphenidate HCl ERCT
methylphenidate HCl ERCT

Placebo Comparator: Placebo to match Quillichew ERCT
Placebo to match Quillichew ERCT
Drug: Placebo
Placebo to Match Quillichew ERCT

Primary Outcome Measures :
  1. Safety-incidence of treatment emergent adverse events [ Time Frame: 6 months ]
    incidence of treatment emergent adverse events

  2. Attention Deficit Hyperactivity Rating Scale - IV (ADHD RS-IV) Preschool-Home Version [ Time Frame: 6 weeks ]
    Change from Baseline to end of double-blind treatment in the total score of the Attention Deficit Hyperactivity Rating Scale - IV (ADHD RS-IV) Preschool-Home Version

Secondary Outcome Measures :
  1. incidence of adverse events [ Time Frame: 6 weeks ]
    incidence of adverse events

  2. Clinical Global Impression of Improvement (CGI-I) Scale Score [ Time Frame: weeks 1-6 ]
    CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Clinician responded to a question: "Compared to your subject's condition at the beginning of treatment, how much has your subject changed?". Improvement was compared to baseline and was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.

  3. Intellectual Performance of Children Using Child Behavior Checklist 4-18 Years (CBCL 4-18) [ Time Frame: Weeks 1-6 ]
    CBCL was standardized for children ages 4 to 18 years and measured child internalizing and externalizing behaviors and total problems. The 4-18 years' checklist contains 140 questions and responses were recorded on a Likert scale: 0 = Not True, 1 = Somewhat or Sometimes True, 2 = Very True or Often True. The range of possible values was 0-280 (0=good to 280=worst).

  4. Children's Global Assessment Scale (CGAS) [ Time Frame: Week 6 ]
    CGAS: clinician-rated global assessment item for children based on symptoms and social functioning in home, school, and community settings. Scores on this single item range from 1 (most impaired) to 100 (healthiest); higher levels indicate greater health, with descriptive anchors for every 10-point interval. Scores above 70 on this scale are considered within the "normal" range; lower score indicates need for increased supervision.

  5. Mean Clinical Global Impression - Severity (CGI-S) score [ Time Frame: Weeks 1-6 ]
    CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   4 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or female child 4-5 years of age at baseline.
  2. Signed and dated informed consent document.
  3. Meets DSM-V criteria for ADHD based on the K-SADS-PL.
  4. ADHD RS-IV Preschool Home Version score at Screening and Baseline >/= 90th percentile for gender and age in >/=1 of the following: hyperactive-impulsive subscale, inattentive subscale, or total score.
  5. Peabody Picture Vocabulary Test 4 (PPVT4)Standard Score >/=70.
  6. Child Global Assessment Scale (CGAS) score </= 55.

Exclusion Criteria:

  1. Treated with atomoxetine within 30 days prior to the Baseline.
  2. Received any investigational products or devices within 30 days prior to the Baseline visit.
  3. History of stimulant nonresponse, intolerability or hypersensitivity to any dose of Quillichew ERCT or other stimulant.
  4. An intelligence quotient (IQ) <70.
  5. History of acute or chronic medical or psychiatric condition or cardiac or laboratory abnormality.
  6. Less than 5th percentile for height or weight at Screening.
  7. History of recent clinically significant self-harming behaviors.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03580005

Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer Identifier: NCT03580005    
Other Study ID Numbers: B7491019
First Posted: July 9, 2018    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents