Attention Deficit Hyperactivity DisorderPhase 4NCT03536390
A 6-week Study to Evaluate the Safety and Efficacy of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD
A Phase 4 study testing Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT) in people with Attention Deficit Hyperactivity Disorder, run by Pfizer.
Trial summary
This 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. Read more about this study
- Who is it for?
- Ages 48 to 69 months
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 19 Sep 2018to 22 Apr 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 48 to 69 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female child 4-5 years of age at screening.
- Signed and dated informed consent provided by the subject's parent/legal and assent of the child (as applicable).
- Meets DSM-5 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 (PPVT-4)Standard Score >/=70.
- Child Global Assessment Scale (CGAS) score </= 55.
- 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.
- 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
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 methylphenidate or other stimulant. If a known allergy to D\&C red #30, he/she should not be enrolled in the study.
- 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 Methylphenidate Hydrochloride (Hcl) Extended Release Chewable Tablet (Erct) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (Adhd)
This 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.
Read the detailed description
Phase 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)
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (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 Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT)Drug
Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT)
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | one chewable tablet once daily in morning. Receives: Drug: Placebo |
| Methylphenidate Hydrochloride Extended Release Chewable Tablet | Experimental | one chewable tablet once daily in morning. Receives: Drug: Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Basline, 6 Weeks
Secondary outcomes (7)
Safety-incidence of treatment emergent adverse events
incidence of treatment emergent adverse events
Measured: 6 Weeks
Change from Baseline in Clinical Global Impression - Severity (CGI-S) score
The CGI-S is a one-item scale for the clinician to assess their impression of the severity of a subject's current state of illness relative to clinician's past experience with patients who have the same diagnosis. A subject's severity of mental illness is assessed considering a clinician's total clinical experience using a scale from 1 to 7 defined as: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill.
Measured: Baseline, Weeks 1 through 6
Change from Baseline in Clinical Global Impression of Improvement (CGI-I) Scale Score
The CGI-I is a one-item scale to compare the subject's current condition to the condition at the Baseline (Day -1) visit using a scale from 1 to 7 defined as: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.
Measured: Baseline, Weeks 1 through 6
ADHD RS-IV Preschool-Home Version Total score
The ADHD RS-IV Preschool Version is an 18-item scale corresponding to the 18 items in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision criteria that is divided into 2 subscales: hyperactivity/impulsivity and inattentiveness. Each item is scored on a 4-point scale ranging from 0 = never/rarely to 3 = very often.
Measured: Weeks 1 through 5
ADHD RS-IV Preschool-Home Version hyperactivity and inattention subscales scores
The ADHD RS-IV Preschool Version is an 18-item scale corresponding to the 18 items in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision criteria that is divided into 2 subscales: hyperactivity/impulsivity and inattentiveness. Each item is scored on a 4-point scale ranging from 0 = never/rarely to 3 = very often.
Measured: Weeks 1 through 6
ADHD RS-IV Preschool-School Version Total score
The ADHD RS-IV Preschool - School Version will be completed by the subject's teacher.
Measured: Weeks 3 and 6
ADHD RS-IV Preschool-School Version hyperactivity and inattention subscales scores
The ADHD RS-IV Preschool - School Version will be completed by the subject's teacher.
Measured: Weeks 3 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start19 Sep 2018 (estimated)
- Primary completion22 Apr 2021 (estimated)
- Study completion22 Apr 2021 (estimated)
Why it stopped: The study was cancelled prior to the enrollment of any participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Double-blind, placebo-controlled, parallel group study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536390
- Sponsor's protocol ID
- B7491017
- Status last verified
- Oct 2018
- First submitted
- 4 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03536390
- Acronym / sponsor ID
- B7491017
- Conditions
- Attention Deficit Hyperactivity Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was cancelled prior to the enrollment of any participants.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2018 (estimated)
- Primary completion
- 22 Apr 2021 (estimated)
- Study completion
- 22 Apr 2021 (estimated)
- First posted
- 24 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 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 description
Phase 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, placebo-controlled, parallel group study.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placeboone chewable tablet once daily in morning. |
| Methylphenidate Hydrochloride Extended Release Chewable Tablet | Experimental | Drug: Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT)one chewable tablet once daily in morning. |
Who may qualify
- Ages
- 48 to 69 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Male or female child 4-5 years of age at screening.
- Signed and dated informed consent provided by the subject's parent/legal and assent of the child (as applicable).
- Meets DSM-5 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 (PPVT-4)Standard Score >/=70.
Key exclusion criteria (7 listed)
- 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 methylphenidate or other stimulant. If a known allergy to D\&C red #30, he/she should not be enrolled in the study.
- An intelligence quotient (IQ) <70.
- History of acute or chronic medical or psychiatric condition or cardiac or laboratory abnormality.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT)Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT) | Drug | Methylphenidate Hydrochloride Extended Release Chewable Tablet |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Attention Deficit Hyperactivity Rating Scale - IV (ADHD RS-IV) Preschool-Home Version
Time frame: Basline, 6 Weeks
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
7 secondary outcomes
Safety-incidence of treatment emergent adverse events
Time frame: 6 Weeks
Change from Baseline in Clinical Global Impression - Severity (CGI-S) score
Time frame: Baseline, Weeks 1 through 6
Change from Baseline in Clinical Global Impression of Improvement (CGI-I) Scale Score
Time frame: Baseline, Weeks 1 through 6
ADHD RS-IV Preschool-Home Version Total score
Time frame: Weeks 1 through 5
ADHD RS-IV Preschool-Home Version hyperactivity and inattention subscales scores
Time frame: Weeks 1 through 6
ADHD RS-IV Preschool-School Version Total score
Time frame: Weeks 3 and 6
ADHD RS-IV Preschool-School Version hyperactivity and inattention subscales scores
Time frame: Weeks 3 and 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2018.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: 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
Related trials for Attention Deficit Hyperactivity Disorder
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
RecruitingPhase 2
A Study to Evaluate Safety and Efficacy of ALKS 7290 Compared With Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder (ALKS 7290-201)
Attention Deficit Disorder With Hyperactivity (ADHD)
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingObservational study
Pharmacogenomics of Stimulant Treatment Response
Attention-Deficit/ Hyperactivity Disorder (ADHD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT) in people with 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 8 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?
Attention Deficit Hyperactivity Rating Scale - IV (ADHD RS-IV) Preschool-Home Version (time frame: Basline, 6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.