A 12-Month Open Label Safety Study of Aptensio XR® in Children Ages 4-5 Years Diagnosed With ADHD (EF004)

A 12-Month Open Label Safety Study of Methylphenidate Hydrochloride Extended-Release Capsules (Aptensio XR®) in Children Ages 4-5 Years Diagnosed With Attention-Deficit/Hyperactivity Disorder (ADHD)

The primary objective of this study is to evaluate the long-term safety and tolerability of methylphenidate hydrochloride extended-release capsules (Aptensio XR®) in children aged 4-5 years who have been diagnosed with attention-deficit/hyperactivity disorder (ADHD).

Safety and tolerability will be evaluated by assessing treatment-emergent adverse events (TEAEs) blood pressure, pulse, height, weight, electrocardiograms (ECGs), laboratory The primary objective of this study is to evaluate the long-term (12-month) safety and tolerability of Aptensio XR® in children aged 4 to less than 6 years who have been diagnosed with ADHD.

Safety and tolerability will be evaluated by assessing treatment-emergent adverse events (TEAEs) blood pressure, pulse, height, weight, electrocardiograms (ECGs), laboratory values and Columbia Suicide Severity Rating Scale (C-SSRS). Disturbances in sleep (quantity and quality) patterns will also be assessed using the Child Sleep Habits Questionnaire (CSHQ).

Secondary objectives include assessment of long-term efficacy of Aptensio XR®.

Secondary measures include:

• Investigator administered Attention-Deficit/Hyperactivity Disorder Rating Scale Preschool Version (ADHD-RS-IV Preschool Version)
• Clinical Global Impressions-Severity Scale (CGI-S )
• Connors Early Childhood Behavior-Parent Short form [Conners EC BEH-P(S)]

Study Overview

• Status: Unknown
• Conditions: Attention Deficit Disorder With Hyperactivity
• Intervention / Treatment: Drug: Aptensio XR

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Center for Psychiatry And Behavioral Medicine Inc.
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 6 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female subjects aged 4 to less than 6 years inclusive at the time consent was given to participate in Prior Studies. New Subjects must be at least 4 years but less than 6 years of age when written consent is given to participate in this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 10 mg Aptensio XR; 10 mg methylphenidate, extended release	Drug: Aptensio XR; Orally-administered extended release formulation of methylphenidate; once daily dosing; Other Names: Methylphenidate Extended Release
EXPERIMENTAL: 15 mg Aptensio XR; 15 mg methylphenidate, extended release	Drug: Aptensio XR; Orally-administered extended release formulation of methylphenidate; once daily dosing; Other Names: Methylphenidate Extended Release
EXPERIMENTAL: 20 mg Aptensio XR; 20 mg methylphenidate, extended release once daily	Drug: Aptensio XR; Orally-administered extended release formulation of methylphenidate; once daily dosing; Other Names: Methylphenidate Extended Release
EXPERIMENTAL: 30 mg Aptensio XR; 30 mg methylphenidate, extended release	Drug: Aptensio XR; Orally-administered extended release formulation of methylphenidate; once daily dosing; Other Names: Methylphenidate Extended Release
EXPERIMENTAL: 40 mg Aptensio XR; 40 mg methylphenidate, extended release	Drug: Aptensio XR; Orally-administered extended release formulation of methylphenidate; once daily dosing; Other Names: Methylphenidate Extended Release
EXPERIMENTAL: 50 mg Aptensio XR; 50 mg methylphenidate, extended release	Drug: Aptensio XR; Orally-administered extended release formulation of methylphenidate; once daily dosing; Other Names: Methylphenidate Extended Release
EXPERIMENTAL: 60 mg Aptensio XR; 60 mg methylphenidate, extended release	Drug: Aptensio XR; Orally-administered extended release formulation of methylphenidate; once daily dosing; Other Names: Methylphenidate Extended Release

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-emergent adverse events (TEAEs)	Incidence of TEAEs during maintenance phase	12 month maintenance phase
Columbia Suicide Severity Rating Scale (C-SSRS)	Standardized assessment of suicide risk	12 month maintenance phase
Vital signs	blood pressure, pulse, height, weight	12 month maintenance phase
12-lead electrocardiogram		12 month maintenance phase

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADHD-RS-IV Preschool Version	Investigator administered Attention-Deficit/Hyperactivity Disorder Rating Scale Preschool Version (ADHD-RS-IV Preschool Version) to assess ADHD severity and functioning	12 month maintenance phase
Clinical Global Impressions-Severity Scale (CGI-S)	This scale provides a global rating of illness severity and improvement during the study. The subject is rated relative to the clinician's past experience with other patients who have the same diagnosis. The CGI-S is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (among the most severely ill patients).	12 month maintenance phase
Connors Early Childhood Behavior-Parent Short [ConnorsEC BEH-P(S)]	Assesses behavior of preschool-aged children 2 to 6	12 month maintenance phase

Collaborators and Investigators

• Sponsor: Rhodes Pharmaceuticals, L.P.
• Investigators: Principal Investigator: Scott Kollins, MD, Department of Psychiatry & Behavioral Sciences, Duke University, Durham, NC

Publications and helpful links

General Publications

• Childress AC, Foehl HC, Newcorn JH, Faraone SV, Levinson B, Adjei AL. Long-Term Treatment With Extended-Release Methylphenidate Treatment in Children Aged 4 to <6 Years. J Am Acad Child Adolesc Psychiatry. 2022 Jan;61(1):80-92. doi: 10.1016/j.jaac.2021.03.019. Epub 2021 Apr 20.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (ANTICIPATED): April 1, 2017
• Study Completion (ANTICIPATED): September 1, 2017

Study Registration Dates

• First Submitted: February 4, 2016
• First Submitted That Met QC Criteria: February 8, 2016
• First Posted (ESTIMATE): February 9, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): August 25, 2016
• Last Update Submitted That Met QC Criteria: August 24, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: ADHD; children; methylphenidate
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Methylphenidate
• Other Study ID Numbers: RP-BP-EF004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED