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

A Phase 4, Open-label, Safety, Tolerability And Pharmacokinetic Study Of Methylphenidate Hydrochloride (Hcl) Extended Release Chewable Tablet (Erct) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (Adhd)

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

Study Overview

• Status: Withdrawn
• Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
• Intervention / Treatment: Drug: methylphenidate HCl ERCT

Detailed 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)

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 5 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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. 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 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 laboratory abnormality.
6. Less than 5th percentile for height or weight at Screening.
7. History of recent clinically significant self-harming behaviors.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: methylphenidate HCl ERCT	Drug: methylphenidate HCl ERCT; methylphenidate HCl ERCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameter-Tmax	PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.	2 weeks
PK parameter- Cmax	PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.	2 weeks
PK parameter- AUClast	PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.	2 weeks
PK parameter-AUC0-2	PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.	2 weeks
PK parameter-AUC2-6	PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.	2 weeks
PK parameter-AUC6-24	PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.	2 weeks
PK parameter-AUCinf	PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.	2 weeks
PK parameter- t1/2	PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.	2 weeks
PK parameter-CL/F	PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.	2 weeks
PK parameter-Vz/F	PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of treatment emergent adverse events (safety and tolerability)	incidence of treatment emergent adverse events (safety and tolerability)	2 weeks

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.
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Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 25, 2018
• Primary Completion (ANTICIPATED): December 3, 2020
• Study Completion (ANTICIPATED): December 3, 2020

Study Registration Dates

• First Submitted: May 4, 2018
• First Submitted That Met QC Criteria: June 1, 2018
• First Posted (ACTUAL): June 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 1, 2018
• Last Update Submitted That Met QC Criteria: October 30, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Methylphenidate
• Other Study ID Numbers: B7491020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No