A 6-week Study to Evaluate the Safety and Efficacy of Quillichew ERCT in 4-5 Year Old Children With ADHD.
NCT03580005
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1. Male or female child 4-5 years of age at baseline.
2. Signed and dated informed consent document.
3. Meets DSM-V 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 (PPVT4)Standard Score >/=70.
6. Child Global Assessment Scale (CGAS) score = 55.
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
Quillichew ERCT or other stimulant.
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 | |||||
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Brief Title ICMJE | A 6-week Study to Evaluate the Safety and Efficacy of Quillichew 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 Quillichew (Methylphenidate Hydrochloride (Hcl)) Extended Release Chewable Tablets (Erct) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (Adhd) | ||||
Brief Summary | 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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||||
Condition ICMJE |
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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 | 88 | ||||
Estimated Study Completion Date ICMJE | October 12, 2021 | ||||
Estimated Primary Completion Date | October 12, 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 | 4 Years to 5 Years (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 | NCT03580005 | ||||
Other Study ID Numbers ICMJE | B7491019 | ||||
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 |