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Attention Deficit Hyperactivity Disorder (ADHD)Phase 4NCT03580005

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

A Phase 4 study testing methylphenidate HCl ERCT in people with Attention Deficit Hyperactivity Disorder (ADHD) and Attention Deficit Hyperactivity Disorder, run by Pfizer.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 5 years
What is being tested?
methylphenidate HCl ERCT
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
31 Oct 2018to 12 Oct 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 5 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

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)

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.

Being tested
methylphenidate HCl ERCT, Placebo
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • methylphenidate HCl ERCTDrug

    methylphenidate HCl ERCT

  • PlaceboDrug

    Placebo to Match Quillichew ERCT

Study groups in NCT03580005
Study groupRoleWhat they receive
Quillichew ERCTActive comparatorQuillichew ERCT
Receives: Drug: methylphenidate HCl ERCT
Placebo to match Quillichew ERCTPlacebo comparatorPlacebo to match Quillichew ERCT
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety-incidence of treatment emergent adverse events

    incidence of treatment emergent adverse events

    Measured: 6 months

  2. 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

    Measured: 6 weeks

Secondary outcomes (5)

  1. incidence of adverse events

    incidence of adverse events

    Measured: 6 weeks

  2. 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.

    Measured: weeks 1-6

  3. 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).

    Measured: Weeks 1-6

  4. 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.

    Measured: Week 6

  5. 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

    Measured: Weeks 1-6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2018
  2. Study start31 Oct 2018 (estimated)
  3. Primary completion12 Oct 2021 (estimated)
  4. Study completion12 Oct 2021 (estimated)

Why it stopped: The study was cancelled prior to the enrollment of any participants.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03580005
Sponsor's protocol ID
B7491019
Status last verified
Oct 2018
First submitted
16 May 2018
Last updated
1 Nov 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing methylphenidate HCl ERCT in people with Attention Deficit Hyperactivity Disorder (ADHD) and Attention Deficit Hyperactivity Disorder, run by Pfizer.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 1 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety-incidence of treatment emergent adverse events (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03580005.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2018.

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