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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

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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Recruitment Status : Withdrawn (The study was cancelled prior to the enrollment of any participants.)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

Tracking Information
First Submitted Date  ICMJE May 4, 2018
First Posted Date  ICMJE May 24, 2018
Last Update Posted Date November 1, 2018
Estimated Study Start Date  ICMJE September 19, 2018
Estimated Primary Completion Date April 22, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: May 14, 2018)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2018)
  • Safety-incidence of treatment emergent adverse events [ Time Frame: 6 Weeks ]
    incidence of treatment emergent adverse events
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2018)
  • Safety-incidence of treatment emergent adverse events [ Time Frame: 6 Weeks ]
    incidence of treatment emergent adverse events
  • 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.
  • Change from Baseline in Clinical Global Impression of Improvement (CGI-I) Scale Score [ Time Frame: 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.
  • 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.
  • 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A 6-week Study to Evaluate the Safety and Efficacy of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD
Official Title  ICMJE 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)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE Attention Deficit Hyperactivity Disorder
Intervention  ICMJE
  • Drug: Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT)
    Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT)
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    one chewable tablet once daily in morning.
    Intervention: Drug: Placebo
  • Experimental: Methylphenidate Hydrochloride Extended Release Chewable Tablet
    one chewable tablet once daily in morning.
    Intervention: Drug: Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 30, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: May 14, 2018)
80
Estimated Study Completion Date  ICMJE April 22, 2021
Estimated Primary Completion Date April 22, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 48 Months to 69 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03536390
Other Study ID Numbers  ICMJE B7491017
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP