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A 6-week Study to Evaluate the Safety and Efficacy of Methylphenidate HCl 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.
 
ClinicalTrials.gov Identifier: NCT03536390
Recruitment Status : Withdrawn (The study was cancelled prior to the enrollment of any participants.)
First Posted : May 24, 2018
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
This 6-week study is to determine if the study drug, Methylphenidate Hydrochloride (HCl) Extended-Release Chewable Tablets (ERCT), is safe, tolerable and effective when compared to a sugar pill or placebo in children 4 to 5 years of age with ADHD.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT) Drug: Placebo Phase 4

Detailed Description:
Phase 4 Double-blind, Randomized, Parallel Group, Placebo-controlled Study of the Efficacy And Safety of Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablets (ERCT) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (ADHD)
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind, placebo-controlled, parallel group study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: A Phase 4, Double-blind, Randomized, Parallel Group, Placebo-controlled Study Of The Efficacy And Safety Of Methylphenidate Hydrochloride (Hcl) Extended Release Chewable Tablet (Erct) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (Adhd)
Estimated Study Start Date : September 19, 2018
Estimated Primary Completion Date : April 22, 2021
Estimated Study Completion Date : April 22, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
one chewable tablet once daily in morning.
 Drug: Placebo
Placebo
Experimental: Methylphenidate Hydrochloride Extended Release Chewable Tablet
one chewable tablet once daily in morning.
 Drug: Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT)
Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT)


Outcome Measures
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Primary Outcome Measures :
  1. Attention Deficit Hyperactivity Rating Scale - IV (ADHD RS-IV) Preschool-Home Version [ Time Frame: Basline, 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. Safety-incidence of treatment emergent adverse events [ Time Frame: 6 Weeks ]
    incidence of treatment emergent adverse events

  2. Change from Baseline in Clinical Global Impression - Severity (CGI-S) score [ Time Frame: Baseline, Weeks 1 through 6 ]
    The CGI-S is a one-item scale for the clinician to assess their impression of the severity of a subject's current state of illness relative to clinician's past experience with patients who have the same diagnosis. A subject's severity of mental illness is assessed considering a clinician's total clinical experience using a scale from 1 to 7 defined as: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill.

  3. Change from Baseline in Clinical Global Impression of Improvement (CGI-I) Scale Score [ Time Frame: Baseline, Weeks 1 through 6 ]
    The CGI-I is a one-item scale to compare the subject's current condition to the condition at the Baseline (Day -1) visit using a scale from 1 to 7 defined as: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.

  4. ADHD RS-IV Preschool-Home Version Total score [ Time Frame: Weeks 1 through 5 ]
    The ADHD RS-IV Preschool Version is an 18-item scale corresponding to the 18 items in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision criteria that is divided into 2 subscales: hyperactivity/impulsivity and inattentiveness. Each item is scored on a 4-point scale ranging from 0 = never/rarely to 3 = very often.

  5. ADHD RS-IV Preschool-Home Version hyperactivity and inattention subscales scores [ Time Frame: Weeks 1 through 6 ]
    The ADHD RS-IV Preschool Version is an 18-item scale corresponding to the 18 items in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision criteria that is divided into 2 subscales: hyperactivity/impulsivity and inattentiveness. Each item is scored on a 4-point scale ranging from 0 = never/rarely to 3 = very often.

  6. ADHD RS-IV Preschool-School Version Total score [ Time Frame: Weeks 3 and 6 ]
    The ADHD RS-IV Preschool - School Version will be completed by the subject's teacher.

  7. ADHD RS-IV Preschool-School Version hyperactivity and inattention subscales scores [ Time Frame: Weeks 3 and 6 ]
    The ADHD RS-IV Preschool - School Version will be completed by the subject's teacher.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   48 Months to 69 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female child 4-5 years of age at screening.
  2. Signed and dated informed consent provided by the subject's parent/legal and assent of the child (as applicable).
  3. Meets DSM-5 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 (PPVT-4)Standard Score >/=70.
  6. Child Global Assessment Scale (CGAS) score </= 55.
  7. Participation in a school type program (day care, preschool, kindergarten, transitional kindergarten, or elementary school) for at least >/=2 half days of the week for at least 3 months and that is anticipated to continue during the study.
  8. History of an adequate course of non medication treatment for ADHD based on investigator judgment or, where such treatments are not available, the severity of the subject's ADHD symptoms are such that medication treatment is deemed necessary by the investigator

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 methylphenidate or other stimulant. If a known allergy to D&C red #30, he/she should not be enrolled in the study.
  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.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03536390


Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03536390    
Other Study ID Numbers: B7491017
First Posted: May 24, 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: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

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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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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Methylphenidate
 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