Attention-Deficit/Hyperactivity DisorderPhase 4PK003NCT02470234
Pharmacokinetic Study of Methylphenidate HCl Extended-Release Capsules in Children 4 to Under 6 Years of Age With ADHD
A Phase 4 study testing Methylphenidate HCl ER Capsules, 10 mg, Methylphenidate HCl ER Capsules, 15 mg and Methylphenidate HCl ER Capsules, 20 mg in people with Attention-Deficit/Hyperactivity Disorder, run by Rhodes Pharmaceuticals, L.P. at 2 sites in United States.
Trial summary
To assess the pharmacokinetics of a single dose of Aptensio XR® (methylphenidate hydrochloride extended-release) capsules under fed conditions in male or female children 4 to under 6 years of age with ADHD. Read more about this study
- Who is it for?
- Ages 4 to 5 years
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder
- What is being tested?
- Methylphenidate HCl ER Capsules, 10 mg, Methylphenidate HCl ER Capsules, 15 mg and Methylphenidate HCl ER Capsules, 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jul 2016to 7 Aug 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient is a male or female between the ages of 4 and under 6 years old.
- Patient has a history consistent with ADHD, meets the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD, inattentive, hyperactivity or combined.
- Patient must meet criteria for ADHD diagnosis on Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime (KSADS-PL) and clinical interview by experienced clinician; symptoms must have been present for at least 6 months.
- Subject has had prior behavioral treatment or subject's symptoms are severe enough to warrant treatment without prior behavioral treatment, and patient is on a stable dose of either immediate-release or extended-release methylphenidate.
- Subject must have age- and sex-adjusted ratings of ≥ 90th percentile Total Score on the Attention Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Preschool Version, a Clinical Global Impressions -Severity Score of ≥4 and a Child Global Assessment Scale rating of <65 after methylphenidate washout and prior to obtaining pharmacokinetic samples. Ratings may be completed via telephone on day-1.
- Parents or guardians of patients must have the ability to read and understand the language in which the Informed Consent is written and are mentally and physically competent to provide written informed consents for their child.
- Patient and/or parent are/is able to understand English in order to provide assent and is otherwise able to comply with the study protocol.
Who cannot join
- Patient has allergy to methylphenidate or amphetamines, or history of serious adverse reaction to methylphenidate.
- Patient has a history of tension, agitation, glaucoma, thyrotoxicosis, tachyarrhythmias or severe angina pectoris or patient with serious or unstable medical illness such as asthma, diabetes or seizures.
- A history of motor or vocal tics or Tourette's syndrome
- Patient is receiving monoamine oxidase inhibitors, anticonvulsants (phenobarbital, phenytoin, primidone), coumarin anticoagulants, presser agents, guanethidine, tricyclic antidepressants (imipramine, desipramine, selective serotonin inhibitors (SSRIs), or herbal remedies (e.g., melatonin).
- Patient has serious hypertension.
- Patient has a history of disorders of the sensory organs, particularly deafness, severe or profound retardation.
Show all 11Show fewer
- Patient has any other unstable psychiatric condition requiring treatment.
- Patient is at risk for substance abuse.
- Evidence of current physical, sexual, or emotional abuse
- Living with anyone who currently abuses stimulants or cocaine
- History of bipolar disorder in both biological parents
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke Psychiatry and Behavioral Sciences, Duke University School of Medicine
Durham, North Carolina, 27705
Qps-Mra, Llc
South Miami, Florida, 33143
About this study
Official title: A Pharmacokinetic Study of Aptensio XR® (Methylphenidate Hydrochloride (HCl) Extended-release) Capsules in Male or Female Pre-School Children 4 to Under 6 Years of Age With Attention Deficit Hyperactivity Disorder (ADHD) in Fed Condition
To assess the pharmacokinetics of a single dose of Aptensio XR® (methylphenidate hydrochloride extended-release) capsules under fed conditions in male or female children 4 to under 6 years of age with ADHD.
Read the detailed description
This will be a multi-center, open-label, single-dose, study to assess the pharmacokinetics of Aptensio XR® (methylphenidate hydrochloride extended-release) capsules in male and female children 4 to under 6 years of age with ADHD in fed condition.
Screening Procedures: After obtaining written informed consent from parents, subjects will undergo a complete medical and medication history, demographic data (including sex, age, race, ethnicity, body weight (kg), height (cm), Body Mass Index (BMI) (kg/m2), physical examination, vital signs evaluation (sitting blood pressure, pulse rate, respiration rate, temperature and pulse oximetry), resting 12-lead electrocardiogram (ECG), clinical laboratory tests and concomitant medication within 28 days prior to receiving study drug. On Day 1: subjects will receive a single oral dose of Aptensio XR®.
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Being tested
- Methylphenidate HCl ER Capsules, 10 mg, Methylphenidate HCl ER Capsules, 15 mg, Methylphenidate HCl ER Capsules, 20 mg
- Keywords
- ADHD, Children, Pharmacokinetics
- 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 ER Capsules, 10 mgDrug
Also called Aptensio XR®, 10 mg
Methylphenidate Hydrochloride Extended-Release Capsules, 10 mg administered once daily in the morning
Methylphenidate HCl ER Capsules, 15 mgDrug
Also called Aptensio XR®, 15 mg
Methylphenidate Hydrochloride Extended-Release Capsules, 15 mg administered once daily in the morning
Methylphenidate HCl ER Capsules, 20 mgDrug
Also called Aptensio XR®, 20 mg
Methylphenidate Hydrochloride Extended-Release Capsules, 20 mg administered once daily in the morning
| Study group | Role | What they receive |
|---|---|---|
| Methylphenidate HCl ER Capsules, 10 mg | Experimental | Methylphenidate Hydrochloride Extended Release Capsules, 10 mg. Active drug, administered once Receives: Drug: Methylphenidate HCl ER Capsules, 10 mg |
| Methylphenidate HCl ER Capsules, 15 mg | Experimental | Methylphenidate Hydrochloride Extended Release Capsules, 15 mg. Active drug, administered once Receives: Drug: Methylphenidate HCl ER Capsules, 15 mg |
| Methylphenidate HCl ER Capsules, 20 mg | Experimental | Methylphenidate Hydrochloride Extended Release Capsules, 20 mg. Active drug, administered once Receives: Drug: Methylphenidate HCl ER Capsules, 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum plasma concentration
Measured: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose
AUC(0-t)
Area under the plasma concentration versus time curve (calculated to the last measurable observation).
AUC: Area Under the Curve
Measured: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose
AUC(0-inf)
Area under the plasma concentration versus time curve, extrapolated to infinity.
AUC: Area Under the Curve
Measured: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose
AUC/D
Dose-normalized AUC0-t. AUC: Area Under the Curve
Measured: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose
CL/F
Apparent clearance. CL: Clearance
Measured: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose
V(Dss)/F
Volume of distribution
Measured: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose
Cmax/Dose
Dose-normalized Cmax
Measured: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose
Secondary outcomes (3)
Tmax
Time to peak plasma concentration
Measured: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose
T1/2
Elimination half-life
Measured: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose
Kel
Terminal elimination constant
Measured: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study start30 Jul 2016
- Primary completion20 Jul 2017
- Study completion7 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention-Deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, single-dose
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhodes Pharmaceuticals, L.P.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Akwete Adjei, Ph.D., Study director, Rhodes Pharmaceuticals, L.P.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470234
- Sponsor's protocol ID
- RP-BP-PK003
- Acronym
- PK003
- Status last verified
- Oct 2021
- First submitted
- 3 Jun 2015
- Last updated
- 24 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Adjei AL, Chaudhary I, Kollins SH, Padilla A. A Pharmacokinetic Study of Methylphenidate Hydrochloride Multilayer Extended-Release Capsules (Aptensio XR(R)) in Preschool-Aged Children with Attention-Deficit/Hyperactivity Disorder. Paediatr Drugs. 2020 Oct;22(5):561-570. doi: 10.1007/s40272-020-00409-z.
PubMed 32776159
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Study of Aptensio XR® (Methylphenidate Hydrochloride (HCl) Extended-release) Capsules in Male or Female Pre-School Children 4 to Under 6 Years of Age With Attention Deficit Hyperactivity Disorder (ADHD) in Fed Condition
- ClinicalTrials.gov ID
- NCT02470234
- Acronym / sponsor ID
- PK003 / RP-BP-PK003
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Keywords
- ADHD, Children, Pharmacokinetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Rhodes Pharmaceuticals, L.P.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2016 (actual)
- Primary completion
- 20 Jul 2017 (actual)
- Study completion
- 7 Aug 2017 (actual)
- First posted
- 12 Jun 2015 (estimated)
- Results
- Posted 24 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the pharmacokinetics of a single dose of Aptensio XR® (methylphenidate hydrochloride extended-release) capsules under fed conditions in male or female children 4 to under 6 years of age with ADHD.
Detailed description
This will be a multi-center, open-label, single-dose, study to assess the pharmacokinetics of Aptensio XR® (methylphenidate hydrochloride extended-release) capsules in male and female children 4 to under 6 years of age with ADHD in fed condition.
Screening Procedures: After obtaining written informed consent from parents, subjects will undergo a complete medical and medication history, demographic data (including sex, age, race, ethnicity, body weight (kg), height (cm), Body Mass Index (BMI) (kg/m2), physical examination, vital signs evaluation (sitting blood pressure, pulse rate, respiration rate, temperature and pulse oximetry), resting 12-lead electrocardiogram (ECG), clinical laboratory tests and concomitant medication within 28 days prior to receiving study drug. On Day 1: subjects will receive a single oral dose of Aptensio XR®.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Open-label, single-dose
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate HCl ER Capsules, 10 mg | Experimental | Drug: Methylphenidate HCl ER Capsules, 10 mgMethylphenidate Hydrochloride Extended Release Capsules, 10 mg. Active drug, administered once |
| Methylphenidate HCl ER Capsules, 15 mg | Experimental | Drug: Methylphenidate HCl ER Capsules, 15 mgMethylphenidate Hydrochloride Extended Release Capsules, 15 mg. Active drug, administered once |
| Methylphenidate HCl ER Capsules, 20 mg | Experimental | Drug: Methylphenidate HCl ER Capsules, 20 mgMethylphenidate Hydrochloride Extended Release Capsules, 20 mg. Active drug, administered once |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Patient is a male or female between the ages of 4 and under 6 years old.
- Patient has a history consistent with ADHD, meets the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD, inattentive, hyperactivity or combined.
- Patient must meet criteria for ADHD diagnosis on Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime (KSADS-PL) and clinical interview by experienced clinician; symptoms must have been present for at least 6 months.
- Subject has had prior behavioral treatment or subject's symptoms are severe enough to warrant treatment without prior behavioral treatment, and patient is on a stable dose of either immediate-release or extended-release methylphenidate.
- Subject must have age- and sex-adjusted ratings of ≥ 90th percentile Total Score on the Attention Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Preschool Version, a Clinical Global Impressions -Severity Score of ≥4 and a Child Global Assessment Scale rating of <65 after methylphenidate washout and prior to obtaining pharmacokinetic samples. Ratings may be completed via telephone on day-1.
Key exclusion criteria (11 listed)
- Patient has allergy to methylphenidate or amphetamines, or history of serious adverse reaction to methylphenidate.
- Patient has a history of tension, agitation, glaucoma, thyrotoxicosis, tachyarrhythmias or severe angina pectoris or patient with serious or unstable medical illness such as asthma, diabetes or seizures.
- A history of motor or vocal tics or Tourette's syndrome
- Patient is receiving monoamine oxidase inhibitors, anticonvulsants (phenobarbital, phenytoin, primidone), coumarin anticoagulants, presser agents, guanethidine, tricyclic antidepressants (imipramine, desipramine, selective serotonin inhibitors (SSRIs), or herbal remedies (e.g., melatonin).
- Patient has serious hypertension.
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 ER Capsules, 10 mgAlso: Aptensio XR®, 10 mgMethylphenidate Hydrochloride Extended-Release Capsules, 10 mg administered once daily in the morning | Drug | Methylphenidate HCl ER Capsules, 10 mg |
| Methylphenidate HCl ER Capsules, 15 mgAlso: Aptensio XR®, 15 mgMethylphenidate Hydrochloride Extended-Release Capsules, 15 mg administered once daily in the morning | Drug | Methylphenidate HCl ER Capsules, 15 mg |
| Methylphenidate HCl ER Capsules, 20 mgAlso: Aptensio XR®, 20 mgMethylphenidate Hydrochloride Extended-Release Capsules, 20 mg administered once daily in the morning | Drug | Methylphenidate HCl ER Capsules, 20 mg |
Primary outcome
Cmax
Time frame: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose
Maximum plasma concentration
AUC(0-t)
Time frame: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose
Area under the plasma concentration versus time curve (calculated to the last measurable observation). AUC: Area Under the Curve
AUC(0-inf)
Time frame: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose
Area under the plasma concentration versus time curve, extrapolated to infinity. AUC: Area Under the Curve
AUC/D
Time frame: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose
Dose-normalized AUC0-t. AUC: Area Under the Curve
CL/F
Time frame: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose
Apparent clearance. CL: Clearance
V(Dss)/F
Time frame: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose
Volume of distribution
Cmax/Dose
Time frame: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose
Dose-normalized Cmax
3 secondary outcomes
Tmax
Time frame: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose
T1/2
Time frame: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose
Kel
Time frame: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32776159Adjei AL, Chaudhary I, Kollins SH, Padilla A. A Pharmacokinetic Study of Methylphenidate Hydrochloride Multilayer Extended-Release Capsules (Aptensio XR(R)) in Preschool-Aged Children with Attention-Deficit/Hyperactivity Disorder. Paediatr Drugs. 2020 Oct;22(5):561-570. doi: 10.1007/s40272-020-00409-z.
- Individual participant dataSharing planned: No
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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.
Akwete Adjei, Ph.D. study director
Rhodes Pharmaceuticals, L.P.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylphenidate HCl ER Capsules, 10 mg, Methylphenidate HCl ER Capsules, 15 mg and Methylphenidate HCl ER Capsules, 20 mg in people with Attention-Deficit/Hyperactivity Disorder, run by Rhodes Pharmaceuticals, L.P. at 2 sites in United States.
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 11 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: finished, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 24 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cmax (time frame: Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose). The study lists 7 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 NCT02470234, which also lists 1 linked publication.
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 24 Nov 2021.