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

Pfizer

Status and phase: Withdrawn; Phase 4

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Drug: Placebo; Drug: Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03536390

B7491017

Details and patient eligibility

About

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.

Full 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)

Sex: All

Ages: 48 to 69 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

one chewable tablet once daily in morning.

Treatment:

Drug: Placebo

Methylphenidate Hydrochloride Extended Release Chewable Tablet

Experimental group

Description:

one chewable tablet once daily in morning.

Treatment:

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