Clinical trial NCT03536390: A 6-week Study to Evaluate the Safety and Efficacy of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD
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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-05-24
Enrollment: 0
Sex: ALL
Minimum age (years): 48
Maximum age (years): 69
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, placebo-controlled, parallel group study.
Primary purpose: TREATMENT

Brief 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.

Detailed 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)

Eligibility criteria: 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.

Primary outcomes:
measure: Attention Deficit Hyperactivity Rating Scale - IV (ADHD RS-IV) Preschool-Home Version
timeFrame: Basline, 6 Weeks
Secondary outcomes:
measure: Safety-incidence of treatment emergent adverse events
timeFrame: 6 Weeks
measure: Change from Baseline in Clinical Global Impression - Severity (CGI-S) score
timeFrame: Baseline, Weeks 1 through 6
measure: Change from Baseline in Clinical Global Impression of Improvement (CGI-I) Scale Score
timeFrame: Baseline, Weeks 1 through 6
measure: ADHD RS-IV Preschool-Home Version Total score
timeFrame: Weeks 1 through 5
measure: ADHD RS-IV Preschool-Home Version hyperactivity and inattention subscales scores
timeFrame: Weeks 1 through 6
measure: ADHD RS-IV Preschool-School Version Total score
timeFrame: Weeks 3 and 6
measure: ADHD RS-IV Preschool-School Version hyperactivity and inattention subscales scores
timeFrame: Weeks 3 and 6
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: