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

Last updated on November 8, 2019

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Attention Deficit Hyperactivity Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
48-69 months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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. Participation in a school type program (day care, preschool, kindergarten,
transitional kindergarten, or elementary school) for at least >/=2 half days of the
week for at least 3 months and that is anticipated to continue during the study.

8. 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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 known allergy to D&C red #30, he/she should
not be enrolled in the study.

4. An intelligence quotient (IQ)

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.

NCT03536390
Pfizer
Not yet recruiting
A 6-week Study to Evaluate the Safety and Efficacy of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD

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Descriptive Information
Brief Title  ICMJE A 6-week Study to Evaluate the Safety and Efficacy of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD
Official Title  ICMJE A Phase 4, Double-blind, Randomized, Parallel Group, Placebo-controlled Study Of The Efficacy And Safety Of Methylphenidate Hydrochloride (Hcl) Extended Release Chewable Tablet (Erct) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (Adhd)
Brief SummaryThis 6-week study is to determine if the study drug, Methylphenidate Hydrochloride (HCl) Extended-Release Chewable Tablets (ERCT), is safe, tolerable and effective when compared to a sugar pill or placebo in children 4 to 5 years of age with ADHD.
Detailed DescriptionPhase 4 Double-blind, Randomized, Parallel Group, Placebo-controlled Study of the Efficacy And Safety of Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablets (ERCT) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (ADHD)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Double-blind, placebo-controlled, parallel group study.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Double-blind

Primary Purpose: Treatment

Condition  ICMJE Attention Deficit Hyperactivity Disorder
Intervention  ICMJE
  • Drug: Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT)
    Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT)
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    one chewable tablet once daily in morning.
    Intervention: Drug: Placebo
  • Experimental: Methylphenidate Hydrochloride Extended Release Chewable Tablet
    one chewable tablet once daily in morning.
    Intervention: Drug: Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT)
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 30, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: May 14, 2018)
80
Estimated Study Completion Date  ICMJE April 22, 2021
Estimated Primary Completion DateApril 22, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  7. Participation in a school type program (day care, preschool, kindergarten, transitional kindergarten, or elementary school) for at least >/=2 half days of the week for at least 3 months and that is anticipated to continue during the study.
  8. 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 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 48 Months to 69 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03536390
Other Study ID Numbers  ICMJE B7491017
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:Yes
Studies a U.S. FDA-regulated Device Product:No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
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/da...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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