A 12-Month Open Label Safety Study of Aptensio XR® in Children Ages 4-5 Years Diagnosed With ADHD
EF004
1 other identifier
interventional
120
1 country
2
Brief Summary
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 \[Conners EC BEH-P(S)\]
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2016
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2016
CompletedFirst Posted
Study publicly available on registry
February 9, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedAugust 25, 2016
August 1, 2016
7 months
February 4, 2016
August 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (3)
ADHD-RS-IV Preschool Version
12 month maintenance phase
Clinical Global Impressions-Severity Scale (CGI-S)
12 month maintenance phase
Connors Early Childhood Behavior-Parent Short [ConnorsEC BEH-P(S)]
12 month maintenance phase
Study Arms (7)
10 mg Aptensio XR
EXPERIMENTAL10 mg methylphenidate, extended release
15 mg Aptensio XR
EXPERIMENTAL15 mg methylphenidate, extended release
20 mg Aptensio XR
EXPERIMENTAL20 mg methylphenidate, extended release once daily
30 mg Aptensio XR
EXPERIMENTAL30 mg methylphenidate, extended release
40 mg Aptensio XR
EXPERIMENTAL40 mg methylphenidate, extended release
50 mg Aptensio XR
EXPERIMENTAL50 mg methylphenidate, extended release
60 mg Aptensio XR
EXPERIMENTAL60 mg methylphenidate, extended release
Interventions
Orally-administered extended release formulation of methylphenidate; once daily dosing
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Center for Psychiatry and Behavioral Medicine Inc.
Las Vegas, Nevada, 89128, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Related Publications (1)
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.
PMID: 33892111DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ann Childress, MD
Center for Psychiatry And Behavioral Medicine Inc.
- PRINCIPAL INVESTIGATOR
Scott Kollins, MD
Department of Psychiatry & Behavioral Sciences, Duke University, Durham, NC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2016
First Posted
February 9, 2016
Study Start
September 1, 2016
Primary Completion
April 1, 2017
Study Completion
September 1, 2017
Last Updated
August 25, 2016
Record last verified: 2016-08