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)

Pfizer0 sitesSeptember 19, 2018

ConditionsAttention Deficit Hyperactivity Disorder

InterventionsPlacebo Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT)

DrugsMethylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT)Placebo

Overview

Phase: Phase 4
Intervention: Placebo
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Pfizer
Primary Endpoint: Attention Deficit Hyperactivity Rating Scale - IV (ADHD RS-IV) Preschool-Home Version
Status: Withdrawn
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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)

Registry

clinicaltrials.gov

Start Date

September 19, 2018

End Date

April 22, 2021

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female child 4-5 years of age at screening.
•Signed and dated informed consent provided by the subject's parent/legal and assent of the child (as applicable).
•Meets DSM-5 criteria for ADHD based on the K-SADS-PL.
•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.
•Peabody Picture Vocabulary Test 4 (PPVT-4)Standard Score \>/=
•Child Global Assessment Scale (CGAS) score \</=
•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.
•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

•Treated with atomoxetine within 30 days prior to the Baseline.
•Received any investigational products or devices within 30 days prior to the Baseline visit.
•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.
•An intelligence quotient (IQ) \<
•History of acute or chronic medical or psychiatric condition or cardiac or laboratory abnormality.
•Less than 5th percentile for height or weight at Screening.
•History of recent clinically significant self-harming behaviors.

Arms & Interventions

Placebo

one chewable tablet once daily in morning.

Intervention: Placebo

Methylphenidate Hydrochloride Extended Release Chewable Tablet

one chewable tablet once daily in morning.

Intervention: Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT)

Outcomes

Primary Outcomes

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 Outcomes

Change from Baseline in Clinical Global Impression - Severity (CGI-S) score(Baseline, Weeks 1 through 6)
ADHD RS-IV Preschool-School Version Total score(Weeks 3 and 6)
Safety-incidence of treatment emergent adverse events(6 Weeks)
Change from Baseline in Clinical Global Impression of Improvement (CGI-I) Scale Score(Baseline, Weeks 1 through 6)
ADHD RS-IV Preschool-Home Version hyperactivity and inattention subscales scores(Weeks 1 through 6)
ADHD RS-IV Preschool-School Version hyperactivity and inattention subscales scores(Weeks 3 and 6)
ADHD RS-IV Preschool-Home Version Total score(Weeks 1 through 5)