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

Pfizer

Status and phase: Withdrawn; Phase 4

Conditions: Attention Deficit Hyperactivity Disorder; Attention Deficit Hyperactivity Disorder (ADHD)

Treatments: Drug: methylphenidate HCl ERCT; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03580005

B7491019

Details and patient eligibility

About

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.

Sex: All

Ages: 4 to 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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.

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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Quillichew ERCT

Active Comparator group

Description:

Quillichew ERCT

Treatment:

Drug: methylphenidate HCl ERCT

Placebo to match Quillichew ERCT

Placebo Comparator group

Description:

Placebo to match Quillichew ERCT

Treatment:

Drug: Placebo