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CompletedNCT02470234PK003Updated Nov 24, 2021Results posted

Pharmacokinetic Study of Methylphenidate HCl Extended-Release Capsules in Children 4 to Under 6 Years of Age With ADHD

A Phase 4 interventional study of Methylphenidate HCl ER Capsules, 10 mg and Methylphenidate HCl ER Capsules, 15 mg in Attention-Deficit/Hyperactivity Disorder, sponsored by Rhodes Pharmaceuticals, L.P.. Completed at 2 sites in United States. Open to participants aged 4 Years to 5 Years. Per ClinicalTrials.gov, last updated 2021-11-24.

Sponsored by Rhodes Pharmaceuticals, L.P. · Phase 4, Interventional, and Other

Phase
Phase 4
Study type
Interventional
Enrollment
10
Allocation
Non-randomized
Ages
4 Years to 5 Years
Sex
All
01

Study 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 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®.

02

Conditions studied

  • Attention-Deficit/Hyperactivity Disorder

Keywords

  • ADHD
  • Children
  • Pharmacokinetics
03

In context

Hyperkinesis

729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.

This study's enrollment of 10 is below the median of 80 across 583 interventional studies indexed under Hyperkinesis.

Browse Hyperkinesis studies →

Lead sponsor

Rhodes Pharmaceuticals, L.P. is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patient is a male or female between the ages of 4 and under 6 years old.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.

Exclusion criteria

Exclusion Criteria:

  1. Patient has allergy to methylphenidate or amphetamines, or history of serious adverse reaction to methylphenidate.
  2. 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.
  3. A history of motor or vocal tics or Tourette's syndrome
  4. 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).
  5. Patient has serious hypertension.
  6. Patient has a history of disorders of the sensory organs, particularly deafness, severe or profound retardation.
  7. Patient has any other unstable psychiatric condition requiring treatment.
  8. Patient is at risk for substance abuse.
  9. Evidence of current physical, sexual, or emotional abuse
  10. Living with anyone who currently abuses stimulants or cocaine
  11. History of bipolar disorder in both biological parents
05

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Methylphenidate HCl ER Capsules, 10 mg

    Methylphenidate Hydrochloride Extended Release Capsules, 10 mg. Active drug, administered once

    Drug: Methylphenidate HCl ER Capsules, 10 mg

  • Experimental
    Methylphenidate HCl ER Capsules, 15 mg

    Methylphenidate Hydrochloride Extended Release Capsules, 15 mg. Active drug, administered once

    Drug: Methylphenidate HCl ER Capsules, 15 mg

  • Experimental
    Methylphenidate HCl ER Capsules, 20 mg

    Methylphenidate Hydrochloride Extended Release Capsules, 20 mg. Active drug, administered once

    Drug: Methylphenidate HCl ER Capsules, 20 mg

Interventions

  • DrugMethylphenidate HCl ER Capsules, 10 mg

    Methylphenidate Hydrochloride Extended-Release Capsules, 10 mg administered once daily in the morning

    Also known as: Aptensio XR®, 10 mg

  • DrugMethylphenidate HCl ER Capsules, 15 mg

    Methylphenidate Hydrochloride Extended-Release Capsules, 15 mg administered once daily in the morning

    Also known as: Aptensio XR®, 15 mg

  • DrugMethylphenidate HCl ER Capsules, 20 mg

    Methylphenidate Hydrochloride Extended-Release Capsules, 20 mg administered once daily in the morning

    Also known as: Aptensio XR®, 20 mg

06

What researchers measure

Primary outcomes

  1. Cmax

    Maximum plasma concentration

    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

  2. AUC(0-t)

    Area under the plasma concentration versus time curve (calculated to the last measurable observation). AUC: Area Under the Curve

    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

  3. AUC(0-inf)

    Area under the plasma concentration versus time curve, extrapolated to infinity. AUC: Area Under the Curve

    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

  4. AUC/D

    Dose-normalized AUC0-t. AUC: Area Under the Curve

    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

  5. CL/F

    Apparent clearance. CL: Clearance

    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

  6. V(Dss)/F

    Volume of distribution

    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

  7. Cmax/Dose

    Dose-normalized 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

Secondary outcomes

  1. Tmax

    Time to peak plasma concentration

    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

  2. T1/2

    Elimination half-life

    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

  3. Kel

    Terminal elimination constant

    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

07

Results

Posted Nov 24, 2021

Participant flow

It was a parallel design study, where subjects were recruited from July 02, 2016 - July 19, 2017. Eligible subjects received one capsule of Methylphenidate HCl ER (10, 15, 20, 30, or 40 mg) on only one of the 3 dosing days depending on number of subjects recruited up each particular dosing day. Only 1 site was able to recruit subjects.

Participant flow — Overall Study
MilestoneMethylphenidate HCl ER 10 mgMethylphenidate HCl ER 15 mgMethylphenidate HCl ER 20 mg
Started532
Completed532
Not completed000

Outcome measures

PrimaryCmax

Maximum plasma concentration

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
Reported as:
Mean · ng/mL
Cmax
ng/mLMethylphenidate HCl ER 10 mgMethylphenidate HCl ER 15 mgMethylphenidate HCl ER 20 mg
Cmax8.07 ± 1.70210.09 ± 0.62015.45 ± 1.061
PrimaryAUC(0-t)

Area under the plasma concentration versus time curve (calculated to the last measurable observation). AUC: Area Under the Curve

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
Reported as:
Mean · ng*hr/mL
AUC(0-t)
ng*hr/mLMethylphenidate HCl ER 10 mgMethylphenidate HCl ER 15 mgMethylphenidate HCl ER 20 mg
AUC(0-t)89.18 ± 25.047118.49 ± 18.211155.95 ± 35.209
PrimaryAUC(0-inf)

Area under the plasma concentration versus time curve, extrapolated to infinity. AUC: Area Under the Curve

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
Reported as:
Mean · ng*hr/mL
AUC(0-inf)
ng*hr/mLMethylphenidate HCl ER 10 mgMethylphenidate HCl ER 15 mgMethylphenidate HCl ER 20 mg
AUC(0-inf)105.26 ± 21.831140.68 ± 0144.26 ± 0
PrimaryAUC/D

Dose-normalized AUC0-t. AUC: Area Under the Curve

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
Reported as:
Mean · ng*hr/mL/mg
AUC/D
ng*hr/mL/mgMethylphenidate HCl ER 10 mgMethylphenidate HCl ER 15 mgMethylphenidate HCl ER 20 mg
AUC/D8.92 ± 2.5057.90 ± 1.2147.80 ± 1.760
PrimaryCL/F

Apparent clearance. CL: Clearance

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
Reported as:
Mean · L/h
CL/F
L/hMethylphenidate HCl ER 10 mgMethylphenidate HCl ER 15 mgMethylphenidate HCl ER 20 mg Capsule
CL/F97.51 ± 18.095106.63 ± 0138.64 ± 0
PrimaryV(Dss)/F

Volume of distribution

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
Reported as:
Mean · L
V(Dss)/F
LMethylphenidate HCl ER 10 mgMethylphenidate HCl ER 15 mgMethylphenidate HCl ER 20 mg
V(Dss)/F682.49 ± 182.6051952.17 ± 01396.96 ± 0
PrimaryCmax/Dose

Dose-normalized 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
Reported as:
Mean · ng/mL/mg
Cmax/Dose
ng/mL/mgMethylphenidate HCl ER 10 mgMethylphenidate HCl ER 15 mgMethylphenidate HCl ER 20 mg
Cmax/Dose0.81 ± 0.1700.67 ± 0.0410.77 ± 0.053
SecondaryTmax

Time to peak plasma concentration

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
Reported as:
Median · h
Tmax
hMethylphenidate HCl ER 10 mgMethylphenidate HCl ER 15 mgMethylphenidate HCl ER 20 mg
Tmax2.0 (1.0 to 3.0)3.0 (3.0 to 12.0)2.0 (2.0 to 2.0)
SecondaryT1/2

Elimination half-life

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
Reported as:
Mean · h
T1/2
hMethylphenidate HCl ER 10 mgMethylphenidate HCl ER 15 mgMethylphenidate HCl ER 20 mg
T1/24.80 ± 0.46612.69 ± 06.98 ± 0
SecondaryKel

Terminal elimination constant

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
Reported as:
Mean · h-1
Kel
h-1Methylphenidate HCl ER 10 mgMethylphenidate HCl ER 15 mgMethylphenidate HCl ER 20 mg
Kel0.15 ± 0.0150.05 ± 00.10 ± 0

Adverse events

Collected over From check in until 24 hours post dose. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Methylphenidate HCl ER 10 mg0/5 (0%)0/5 (0%)1/5 (20%)
Methylphenidate HCl ER 15 mg0/3 (0%)0/3 (0%)0/3 (0%)
Methylphenidate HCl ER 20 mg0/2 (0%)0/2 (0%)0/2 (0%)
Most frequent other events
Most frequent other events
EventMethylphenidate HCl ER 10 mgMethylphenidate HCl ER 15 mgMethylphenidate HCl ER 20 mg
Upper respiratory tract infectionInfections and infestations1/50/30/2

Baseline characteristics

Age, Continuous
Age, Continuous(Months)Methylphenidate HCl ER 10 mgMethylphenidate HCl ER 15 mgMethylphenidate HCl ER 20 mgTotal
Mean61.0 ± 8.0363.3 ± 5.5170.5 ± 0.7163.6 ± 7.06
Sex: Female, Male
Sex: Female, Male(Participants)Methylphenidate HCl ER 10 mgMethylphenidate HCl ER 15 mgMethylphenidate HCl ER 20 mgTotal
Female1113
Male4217
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Methylphenidate HCl ER 10 mgMethylphenidate HCl ER 15 mgMethylphenidate HCl ER 20 mgTotal
Hispanic or Latino1113
Not Hispanic or Latino4217
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Methylphenidate HCl ER 10 mgMethylphenidate HCl ER 15 mgMethylphenidate HCl ER 20 mgTotal
American Indian or Alaska Native0000
Asian0000
Native Hawaiian or Other Pacific Islander0000
Black or African American4116
White0112
More than one race1102
Unknown or Not Reported0000
BMI
BMI(kg/m^2)Methylphenidate HCl ER 10 mgMethylphenidate HCl ER 15 mgMethylphenidate HCl ER 20 mgTotal
Mean15.3 ± 0.5515.3 ± 0.9815.3 ± 2.2615.3 ± 0.96
08

Study locations

2 sites
  • Qps-Mra, Llc
    South Miami, Florida 33143, United States
  • Duke Psychiatry and Behavioral Sciences, Duke University School of Medicine
    Durham, North Carolina 27705, United States
09

References and documents

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 documents

  • Protocol and statistical analysis plan · Feb 13, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02470234
Lead sponsor
Rhodes Pharmaceuticals, L.P.
Responsible party
Sponsor
First posted
Jun 12, 2015
Start date
Jul 30, 2016
Primary completion
Jul 20, 2017
Completion
Aug 7, 2017
Results posted
Nov 24, 2021
Last update
Nov 24, 2021

Study contacts

Akwete Adjei, Ph.D.
study director · Rhodes Pharmaceuticals, L.P.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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