Safety, Tolerability and PK Study of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD.

Last updated: October 30, 2018
Sponsor: Pfizer
Overall Status: Trial Not Available

Phase

4

Condition

Learning Disorders

Attention Deficit/hyperactivity Disorder (Adhd - Adults)

Tourette's Syndrome

Treatment

N/A

Clinical Study ID

NCT03546400
B7491020
  • Ages 48-69
  • All Genders

Study Summary

2-week open-label safety, tolerability and pharmacokinetic study of methylphenidate HCl ERCT in 4-5 year old children with ADHD.

Eligibility Criteria

Inclusion

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 ofthe 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 percentilefor 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. History of an adequate course of non medication treatment for ADHD based oninvestigator judgment or, where such treatments are not available, the severity of thesubject's ADHD symptoms are such that medication treatment is deemed necessary by theinvestigator.

Exclusion

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 Baselinevisit.

  3. History of stimulant nonresponse, intolerability or hypersensitivity to any dose ofmethylphenidate or other stimulant.If a subject has 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 laboratoryabnormality.

  6. Less than 5th percentile for height or weight at Screening.

  7. History of recent clinically significant self-harming behaviors.

Study Design

Study Start date:
September 25, 2018
Estimated Completion Date:
December 03, 2020

Study Description

Phase 4, Open-label, Safety, Tolerability And Pharmacokinetic Study Of methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablets (ERCT) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (ADHD)