Attention Deficit Hyperactivity Disorder (ADHD)Phase 4NCT03546400
Safety, Tolerability and PK Study of Methylphenidate HCl 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), run by Pfizer.
Trial summary
2-week open-label safety, tolerability and pharmacokinetic study of methylphenidate HCl ERCT in 4-5 year old children 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 (ADHD)
- What is being tested?
- methylphenidate HCl ERCT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 25 Sep 2018to 3 Dec 2020
- 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.
- 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 subject has 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, 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.
Read the 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)
- Being tested
- methylphenidate HCl ERCT
- 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
| Study group | Role | What they receive |
|---|---|---|
| methylphenidate HCl ERCT | Other | methylphenidate HCl ERCT Receives: Drug: methylphenidate HCl ERCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameter-Tmax
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
Measured: 2 weeks
PK parameter- Cmax
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
Measured: 2 weeks
PK parameter- AUClast
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
Measured: 2 weeks
PK parameter-AUC0-2
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
Measured: 2 weeks
PK parameter-AUC2-6
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
Measured: 2 weeks
PK parameter-AUC6-24
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
Measured: 2 weeks
PK parameter-AUCinf
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
Measured: 2 weeks
PK parameter- t1/2
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
Measured: 2 weeks
PK parameter-CL/F
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
Measured: 2 weeks
PK parameter-Vz/F
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
Measured: 2 weeks
Secondary outcomes (1)
incidence of treatment emergent adverse events (safety and tolerability)
incidence of treatment emergent adverse events (safety and tolerability)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start25 Sep 2018 (estimated)
- Primary completion3 Dec 2020 (estimated)
- Study completion3 Dec 2020 (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 Disorder (ADHD)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- 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
- NCT03546400
- Sponsor's protocol ID
- B7491020
- 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, 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)
- ClinicalTrials.gov ID
- NCT03546400
- Acronym / sponsor ID
- B7491020
- 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
- 25 Sep 2018 (estimated)
- Primary completion
- 3 Dec 2020 (estimated)
- Study completion
- 3 Dec 2020 (estimated)
- First posted
- 6 Jun 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.
2-week open-label safety, tolerability and pharmacokinetic study of methylphenidate HCl ERCT in 4-5 year old children with ADHD.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| methylphenidate HCl ERCT | Other | Drug: methylphenidate HCl ERCTmethylphenidate HCl ERCT |
Who may qualify
- Ages
- 48 to 69 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 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 subject has 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 HCl ERCTmethylphenidate HCl ERCT | Drug | methylphenidate HCl ERCT |
Primary outcome
PK parameter-Tmax
Time frame: 2 weeks
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
PK parameter- Cmax
Time frame: 2 weeks
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
PK parameter- AUClast
Time frame: 2 weeks
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
PK parameter-AUC0-2
Time frame: 2 weeks
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
PK parameter-AUC2-6
Time frame: 2 weeks
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
PK parameter-AUC6-24
Time frame: 2 weeks
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
PK parameter-AUCinf
Time frame: 2 weeks
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
PK parameter- t1/2
Time frame: 2 weeks
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
PK parameter-CL/F
Time frame: 2 weeks
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
PK parameter-Vz/F
Time frame: 2 weeks
PK profile of methylphenidate following a single oral dose of 30 mg methylphenidate HCl ERCT.
1 secondary outcome
incidence of treatment emergent adverse events (safety and tolerability)
Time frame: 2 weeks
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.
- 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
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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 HCl ERCT in people with Attention Deficit Hyperactivity Disorder (ADHD), 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 7 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. 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?
PK parameter-Tmax (time frame: 2 weeks). The study lists 10 primary outcomes in all. 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.