A 6-week Study to Evaluate the Safety and Efficacy of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD
NCT03536390
ABOUT THIS STUDY
FOR MORE INFORMATION
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Adult Trials: 18+ Years
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
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
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.
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| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title ICMJE | A 6-week Study to Evaluate the Safety and Efficacy of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD | ||||
| Official Title ICMJE | 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) | ||||
| 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) | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Double-blind, placebo-controlled, parallel group study. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Double-blind Primary Purpose: Treatment
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| Condition ICMJE | Attention Deficit Hyperactivity Disorder | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Withdrawn | ||||
| Actual Enrollment ICMJE | 0 | ||||
| Original Estimated Enrollment ICMJE | 80 | ||||
| Estimated Study Completion Date ICMJE | April 22, 2021 | ||||
| Estimated Primary Completion Date | April 22, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 48 Months to 69 Months (Child) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03536390 | ||||
| Other Study ID Numbers ICMJE | B7491017 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Pfizer | ||||
| Study Sponsor ICMJE | Pfizer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Pfizer | ||||
| Verification Date | October 2018 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||