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

Phase 4

Withdrawn

• Conditions: Attention Deficit Hyperactivity Disorder; Attention Deficit Hyperactivity Disorder (ADHD)
• Interventions: Drug: Placebo; Drug: methylphenidate HCl ERCT

• Registration Number: NCT03580005
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-16
• Study First Submitted QC: 2018-07-05
• Study First Posted: 2018-07-09
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-30
• Study Start: 2018-10-31
• Last Update Posted: 2018-11-01
• Primary Completion: 2021-10-12
• Study Completion: 2021-10-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo to match Quillichew ERCT	Placebo	Placebo to match Quillichew ERCT
Quillichew ERCT	methylphenidate HCl ERCT	Quillichew ERCT

Primary Outcome Measures

Name	Time	Method
Safety-incidence of treatment emergent adverse events	6 months	incidence of treatment emergent adverse events
Attention Deficit Hyperactivity Rating Scale - IV (ADHD RS-IV) Preschool-Home Version	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

Name	Time	Method
incidence of adverse events	6 weeks	incidence of adverse events
Clinical Global Impression of Improvement (CGI-I) Scale Score	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.
Intellectual Performance of Children Using Child Behavior Checklist 4-18 Years (CBCL 4-18)	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).
Children's Global Assessment Scale (CGAS)	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.
Mean Clinical Global Impression - Severity (CGI-S) score	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