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

Study Overview
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Brief Summary
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A 6-week double-blind study to evaluate the safety and efficacy of Quillichew extended release chewable tablets in 4-5 year old children with attention deficit hyperactivity disorder.

Official Title
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A Phase 4, Double-blind, Randomized, Parallel Group, Placebo-controlled Study Of The Efficacy And Safety Of Quillichew (Methylphenidate Hydrochloride (Hcl)) Extended Release Chewable Tablets (Erct) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (Adhd)

Conditions
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Attention Deficit Hyperactivity Disorder (ADHD), Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Drug: methylphenidate HCl ERCT
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female child 4-5 years of age at baseline. Signed and dated informed consent document. Meets DSM-V 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 (PPVT4)Standard Score >/=70. Child Global Assessment Scale (CGAS) score </= 55. 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 Quillichew ERCT or other stimulant. 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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Quillichew ERCT<br>Quillichew ERCT | Drug: methylphenidate HCl ERCT<br>* methylphenidate HCl ERCT<br>|
| Placebo Comparator: Placebo to match Quillichew ERCT<br>Placebo to match Quillichew ERCT | Drug: Placebo<br>* Placebo to Match Quillichew ERCT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety-incidence of treatment emergent adverse events | incidence of treatment emergent adverse events | 6 months | 
| 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 | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of adverse events | incidence of adverse events | 6 weeks | 
| Clinical Global Impression of Improvement (CGI-I) Scale Score | CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Clinician responded to a question: Compared to your subject's condition at the beginning of treatment, how much has your subject changed?. Improvement was compared to baseline and was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. | weeks 1-6 | 
| Intellectual Performance of Children Using Child Behavior Checklist 4-18 Years (CBCL 4-18) | CBCL was standardized for children ages 4 to 18 years and measured child internalizing and externalizing behaviors and total problems. The 4-18 years' checklist contains 140 questions and responses were recorded on a Likert scale: 0 = Not True, 1 = Somewhat or Sometimes True, 2 = Very True or Often True. The range of possible values was 0-280 (0=good to 280=worst). | Weeks 1-6 | 
| Children's Global Assessment Scale (CGAS) | CGAS: clinician-rated global assessment item for children based on symptoms and social functioning in home, school, and community settings. Scores on this single item range from 1 (most impaired) to 100 (healthiest); higher levels indicate greater health, with descriptive anchors for every 10-point interval. Scores above 70 on this scale are considered within the normal range; lower score indicates need for increased supervision. | Week 6 | 
| Mean Clinical Global Impression - Severity (CGI-S) score | CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected | Weeks 1-6 |