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

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Primary Purpose

Status

Withdrawn

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

methylphenidate HCl ERCT

Placebo

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder (ADHD)

Eligibility Criteria

4 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female child 4-5 years of age at baseline.
Signed and dated informed consent document.
Meets DSM-V criteria for ADHD based on the K-SADS-PL.
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.
Peabody Picture Vocabulary Test 4 (PPVT4)Standard Score >/=70.
Child Global Assessment Scale (CGAS) score </= 55.

Exclusion Criteria:

Treated with atomoxetine within 30 days prior to the Baseline.
Received any investigational products or devices within 30 days prior to the Baseline visit.
History of stimulant nonresponse, intolerability or hypersensitivity to any dose of Quillichew ERCT or other stimulant.
An intelligence quotient (IQ) <70.
History of acute or chronic medical or psychiatric condition or cardiac or laboratory abnormality.
Less than 5th percentile for height or weight at Screening.
History of recent clinically significant self-harming behaviors.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Quillichew ERCT

Placebo to match Quillichew ERCT

Arm Description

Quillichew ERCT

Placebo to match Quillichew ERCT

Outcomes

Primary Outcome Measures

Safety-incidence of treatment emergent adverse events

incidence of treatment emergent adverse events

Attention Deficit Hyperactivity Rating Scale - IV (ADHD RS-IV) Preschool-Home Version

Change from Baseline to end of double-blind treatment in the total score of the Attention Deficit Hyperactivity Rating Scale - IV (ADHD RS-IV) Preschool-Home Version

Secondary Outcome Measures

incidence of adverse events

Clinical Global Impression of Improvement (CGI-I) Scale Score

CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Clinician responded to a question: "Compared to your subject's condition at the beginning of treatment, how much has your subject changed?". Improvement was compared to baseline and was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.

Intellectual Performance of Children Using Child Behavior Checklist 4-18 Years (CBCL 4-18)

CBCL was standardized for children ages 4 to 18 years and measured child internalizing and externalizing behaviors and total problems. The 4-18 years' checklist contains 140 questions and responses were recorded on a Likert scale: 0 = Not True, 1 = Somewhat or Sometimes True, 2 = Very True or Often True. The range of possible values was 0-280 (0=good to 280=worst).

Children's Global Assessment Scale (CGAS)

CGAS: clinician-rated global assessment item for children based on symptoms and social functioning in home, school, and community settings. Scores on this single item range from 1 (most impaired) to 100 (healthiest); higher levels indicate greater health, with descriptive anchors for every 10-point interval. Scores above 70 on this scale are considered within the "normal" range; lower score indicates need for increased supervision.

Mean Clinical Global Impression - Severity (CGI-S) score

CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected

Full Information

NCT ID

NCT03580005

First Posted

May 16, 2018

Last Updated

October 30, 2018

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT03580005

Brief Title

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

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Withdrawn

Why Stopped

The study was cancelled prior to the enrollment of any participants.

Study Start Date

October 31, 2018 (Anticipated)

Primary Completion Date

October 12, 2021 (Anticipated)

Study Completion Date

October 12, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit Hyperactivity Disorder (ADHD), Attention Deficit Hyperactivity Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Quillichew ERCT

Arm Type

Active Comparator

Arm Description

Quillichew ERCT

Arm Title

Placebo to match Quillichew ERCT

Arm Type

Placebo Comparator

Arm Description

Placebo to match Quillichew ERCT

Intervention Type

Drug

Intervention Name(s)

methylphenidate HCl ERCT

Intervention Description

methylphenidate HCl ERCT

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo to Match Quillichew ERCT

Primary Outcome Measure Information:

Title

Safety-incidence of treatment emergent adverse events

Description

incidence of treatment emergent adverse events

Time Frame

6 months

Title

Attention Deficit Hyperactivity Rating Scale - IV (ADHD RS-IV) Preschool-Home Version

Description

Change from Baseline to end of double-blind treatment in the total score of the Attention Deficit Hyperactivity Rating Scale - IV (ADHD RS-IV) Preschool-Home Version

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

incidence of adverse events

Description

incidence of adverse events

Time Frame

6 weeks

Title

Clinical Global Impression of Improvement (CGI-I) Scale Score

Description

CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Clinician responded to a question: "Compared to your subject's condition at the beginning of treatment, how much has your subject changed?". Improvement was compared to baseline and was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.

Time Frame

weeks 1-6

Title

Intellectual Performance of Children Using Child Behavior Checklist 4-18 Years (CBCL 4-18)

Description

CBCL was standardized for children ages 4 to 18 years and measured child internalizing and externalizing behaviors and total problems. The 4-18 years' checklist contains 140 questions and responses were recorded on a Likert scale: 0 = Not True, 1 = Somewhat or Sometimes True, 2 = Very True or Often True. The range of possible values was 0-280 (0=good to 280=worst).

Time Frame

Weeks 1-6

Title

Children's Global Assessment Scale (CGAS)

Description

CGAS: clinician-rated global assessment item for children based on symptoms and social functioning in home, school, and community settings. Scores on this single item range from 1 (most impaired) to 100 (healthiest); higher levels indicate greater health, with descriptive anchors for every 10-point interval. Scores above 70 on this scale are considered within the "normal" range; lower score indicates need for increased supervision.

Time Frame

Week 6

Title

Mean Clinical Global Impression - Severity (CGI-S) score

Description

CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected

Time Frame

Weeks 1-6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Male or female child 4-5 years of age at baseline. Signed and dated informed consent document. Meets DSM-V criteria for ADHD based on the K-SADS-PL. 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. Peabody Picture Vocabulary Test 4 (PPVT4)Standard Score >/=70. Child Global Assessment Scale (CGAS) score </= 55. Exclusion Criteria: Treated with atomoxetine within 30 days prior to the Baseline. Received any investigational products or devices within 30 days prior to the Baseline visit. History of stimulant nonresponse, intolerability or hypersensitivity to any dose of Quillichew ERCT or other stimulant. An intelligence quotient (IQ) <70. History of acute or chronic medical or psychiatric condition or cardiac or laboratory abnormality. Less than 5th percentile for height or weight at Screening. History of recent clinically significant self-harming behaviors.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7491019&StudyName=A+6-month+Open-label+Extension+Study+Of+Protocol+B7491017

Description