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

NCT02470234 | Completed Phase 4 Results DMC

• 1 other identifier: RP-BP-PK003
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Attention-Deficit/Hyperactivity Disorder

Keywords

ADHD; Children; Pharmacokinetics

Outcome Measures

Primary Outcomes (7)

• Cmax

  Maximum plasma concentration

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

Study Arms (3)

Methylphenidate HCl ER Capsules, 10 mg

EXPERIMENTAL

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

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

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

Drug: Methylphenidate HCl ER Capsules, 20 mg

Interventions

Methylphenidate HCl ER Capsules, 10 mg DRUG

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

Also known as: Aptensio XR®, 10 mg

Methylphenidate HCl ER Capsules, 10 mg

Methylphenidate HCl ER Capsules, 15 mg DRUG

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

Also known as: Aptensio XR®, 15 mg

Methylphenidate HCl ER Capsules, 15 mg

Methylphenidate HCl ER Capsules, 20 mg DRUG

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

Also known as: Aptensio XR®, 20 mg

Methylphenidate HCl ER Capsules, 20 mg

Eligibility Criteria

• Age: 4 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Rhodes Pharmaceuticals, L.P.: lead

Study Sites (2)

Qps-Mra, Llc

South Miami, Florida, 33143, United States

Location

Duke Psychiatry and Behavioral Sciences, Duke University School of Medicine

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• 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.

  PMID: 32776159 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Akwete Adjei
• Organization: Rhodes Pharmaceuticals L.P.

akwete.adjei@rhodespharma.com

401-262-9408

Study Officials

• Akwete Adjei, Ph.D.

  Rhodes Pharmaceuticals, L.P.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, single-dose

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 12, 2015
• Study Start: July 30, 2016
• Primary Completion: July 20, 2017
• Study Completion: August 7, 2017
• Last Updated: November 24, 2021
• Results First Posted: November 24, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)