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

Attention Deficit Hyperactivity Disorder Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03580005
• Other study ID #: B7491019
• Status: Withdrawn
• Phase: Phase 4
• Start date: October 31, 2018
• Est. completion date: October 12, 2021

Study information

• Verified date: October 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 12, 2021
• Est. primary completion date: October 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Attention Deficit Hyperactivity Disorder (ADHD)
• Disease
• Hyperkinesis

Intervention

Drug:
• methylphenidate HCl ERCT
methylphenidate HCl ERCT
• Placebo
Placebo to Match Quillichew ERCT

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety-incidence of treatment emergent adverse events	incidence of treatment emergent adverse events	6 months
Primary	Attention Deficit Hyperactivity Rating Scale - IV (ADHD RS-IV) Preschool—Home Version	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	6 weeks
Secondary	incidence of adverse events	incidence of adverse events	6 weeks
Secondary	Clinical Global Impression of Improvement (CGI-I) Scale Score	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.	weeks 1-6
Secondary	Intellectual Performance of Children Using Child Behavior Checklist 4-18 Years (CBCL 4-18)	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).	Weeks 1-6
Secondary	Children's Global Assessment Scale (CGAS)	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.	Week 6
Secondary	Mean Clinical Global Impression - Severity (CGI-S) score	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	Weeks 1-6

External Links

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