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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-19

Study Completion Date

2021-04-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety, Tolerability and PK Study of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD.

NCT03546400

Attention Deficit Hyperactivity Disorder (ADHD)

WITHDRAWN PHASE4

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

NCT03580005

Attention Deficit Hyperactivity Disorder (ADHD) Attention Deficit Hyperactivity Disorder

WITHDRAWN PHASE4

Efficacy and Safety of Methylphenidate HCl ER Capsules in Children and Adolescents With ADHD

NCT01239030

Attention Deficit Hyperactivity Disorder ADHD

COMPLETED PHASE3

A Safety and Effectiveness Study of Methylphenidate HCl Extended-release Tablets in Adults With Attention Deficit Hyperactivity Disorder

NCT00326391

Attention Deficit Disorder With Hyperactivity

COMPLETED PHASE3

Safety and Efficacy of Methylphenidate in Children With Attention-deficit Hyperactivity Disorder (ADHD)

NCT00428792

Attention Deficit Hyperactivity Disorder

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Attention Deficit Hyperactivity Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blind, placebo-controlled, parallel group study.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double-blind

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

one chewable tablet once daily in morning.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Methylphenidate Hydrochloride Extended Release Chewable Tablet

one chewable tablet once daily in morning.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

48 Months

Maximum Eligible Age

69 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No