15 mg Aptensio XR for Attention Deficit Hyperactivity Disorder (ADHD)

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Attention Deficit Hyperactivity Disorder (ADHD)+2 More
Aptensio XR - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study 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)]

Eligible Conditions
  • Attention Deficit Hyperactivity Disorder (ADHD)

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Attention Deficit Hyperactivity Disorder (ADHD)

Study Objectives

4 Primary · 3 Secondary · Reporting Duration: 12 month maintenance phase

12 month maintenance phase
12-lead electrocardiogram
ADHD-RS-IV Preschool Version
Clinical Global Impressions-Severity Scale (CGI-S)
Columbia Suicide Severity Rating Scale (C-SSRS)
Connors Early Childhood Behavior-Parent Short [ConnorsEC BEH-P(S)]
Treatment-emergent adverse events (TEAEs)
Vital signs

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Attention Deficit Hyperactivity Disorder (ADHD)

Side Effects for

Phase 1-Medication First
51%Appetite Loss
40%Insomnia
33%Irritability
29%Picking at skin, nailbiting
21%Dull, tired, listless
21%Worried/Anxious
19%Tearful, depressed
18%Stomachache
13%Motor Tics
13%Headache
12%Buccal-lingual movements
10%Social Withdrawal
1%Hospitalized
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT02039908) in the Phase 1-Medication First ARM group. Side effects include: Appetite Loss with 51%, Insomnia with 40%, Irritability with 33%, Picking at skin, nailbiting with 29%, Dull, tired, listless with 21%.

Trial Design

7 Treatment Groups

15 mg Aptensio XR
1 of 7
20 mg Aptensio XR
1 of 7
10 mg Aptensio XR
1 of 7
40 mg Aptensio XR
1 of 7
50 mg Aptensio XR
1 of 7
30 mg Aptensio XR
1 of 7
60 mg Aptensio XR
1 of 7
Experimental Treatment

120 Total Participants · 7 Treatment Groups

Primary Treatment: 15 mg Aptensio XR · No Placebo Group · Phase 4

15 mg Aptensio XR
Drug
Experimental Group · 1 Intervention: Aptensio XR · Intervention Types: Drug
20 mg Aptensio XR
Drug
Experimental Group · 1 Intervention: Aptensio XR · Intervention Types: Drug
10 mg Aptensio XR
Drug
Experimental Group · 1 Intervention: Aptensio XR · Intervention Types: Drug
40 mg Aptensio XR
Drug
Experimental Group · 1 Intervention: Aptensio XR · Intervention Types: Drug
50 mg Aptensio XR
Drug
Experimental Group · 1 Intervention: Aptensio XR · Intervention Types: Drug
30 mg Aptensio XR
Drug
Experimental Group · 1 Intervention: Aptensio XR · Intervention Types: Drug
60 mg Aptensio XR
Drug
Experimental Group · 1 Intervention: Aptensio XR · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexmethylphenidate
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 month maintenance phase

Who is running the clinical trial?

Rhodes Pharmaceuticals, L.P.Lead Sponsor
10 Previous Clinical Trials
1,672 Total Patients Enrolled
9 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
1,600 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Scott Kollins, MDPrincipal InvestigatorDepartment of Psychiatry & Behavioral Sciences, Duke University, Durham, NC
Ann Childress, MDPrincipal InvestigatorCenter for Psychiatry And Behavioral Medicine Inc.
7 Previous Clinical Trials
1,435 Total Patients Enrolled
7 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
1,435 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Eligibility Criteria

Age < 18 · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 22nd, 2021

Last Reviewed: October 27th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.