A 6-week Study to Evaluate the Safety and Efficacy of Methylphenidate HCl 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 Methylphenidate Hydrochloride (Hcl) Extended Release Chewable Tablet (Erct) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (Adhd)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03536390
• Other study ID #: B7491017
• Status: Withdrawn
• Phase: Phase 4
• Start date: September 19, 2018
• Est. completion date: April 22, 2021

Study information

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

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 22, 2021
• Est. primary completion date: April 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 48 Months to 69 Months

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Basline, 6 Weeks
Secondary	Safety-incidence of treatment emergent adverse events	incidence of treatment emergent adverse events	6 Weeks
Secondary	Change from Baseline in Clinical Global Impression - Severity (CGI-S) score	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.	Baseline, Weeks 1 through 6
Secondary	Change from Baseline in Clinical Global Impression of Improvement (CGI-I) Scale Score	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.	Baseline, Weeks 1 through 6
Secondary	ADHD RS-IV Preschool—Home Version Total score	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.	Weeks 1 through 5
Secondary	ADHD RS-IV Preschool—Home Version hyperactivity and inattention subscales scores	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.	Weeks 1 through 6
Secondary	ADHD RS-IV Preschool—School Version Total score	The ADHD RS-IV Preschool - School Version will be completed by the subject's teacher.	Weeks 3 and 6
Secondary	ADHD RS-IV Preschool—School Version hyperactivity and inattention subscales scores	The ADHD RS-IV Preschool - School Version will be completed by the subject's teacher.	Weeks 3 and 6

External Links

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•   To obtain contact information for a study center near you, click here.
•   To obtain contact information for a study center near you, click here.
•   To obtain contact information for a study center near you, click here.