Safety, Tolerability and PK Study of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03546400
Recruitment Status :
(The study was cancelled prior to the enrollment of any participants.)
2-week open-label safety, tolerability and pharmacokinetic study of methylphenidate HCl ERCT in 4-5 year old children with ADHD.
Condition or disease
Attention Deficit Hyperactivity Disorder (ADHD)
Drug: methylphenidate HCl ERCT
Phase 4, Open-label, Safety, Tolerability And Pharmacokinetic Study Of methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablets (ERCT) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (ADHD)
A Phase 4, Open-label, Safety, Tolerability And Pharmacokinetic Study Of Methylphenidate Hydrochloride (Hcl) Extended Release Chewable Tablet (Erct) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (Adhd)
Estimated Study Start Date :
September 25, 2018
Estimated Primary Completion Date :
December 3, 2020
Estimated Study Completion Date :
December 3, 2020
Resource links provided by the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
48 Months to 69 Months (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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 >/=70.
Child Global Assessment Scale (CGAS) score </= 55.
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.
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 subject has a known allergy to D&C red #30, he/she should not be enrolled in the study.
An intelligence quotient (IQ) <70.
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.
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests
Layout table for additional information
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:
Layout table for MeSH terms
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Nervous System Diseases
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action