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Central Nervous System Stimulant

40 mg Aptensio XR for Attention Deficit Hyperactivity Disorder (ADHD) (EF004 Trial)

Phase 4
Waitlist Available
Led By Scott Kollins, MD
Research Sponsored by Rhodes Pharmaceuticals, L.P.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month maintenance phase
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

EF004 Trial 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)

EF004 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

EF004 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month maintenance phase
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month maintenance phase for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
12-lead electrocardiogram
Columbia Suicide Severity Rating Scale (C-SSRS)
Treatment-emergent adverse events (TEAEs)
+1 more
Secondary outcome measures
ADHD-RS-IV Preschool Version
Clinical Global Impressions-Severity Scale (CGI-S)
Connors Early Childhood Behavior-Parent Short [ConnorsEC BEH-P(S)]

Side effects data

From 2018 Phase 4 trial • 158 Patients • NCT02683265
21%
Decreased appetite
18%
Weight decreased
15%
Insomnia
14%
Irritability
13%
Hypertension
12%
Emotional Disorder
10%
Affect lability
8%
Headache
7%
Initial insomnia
7%
Abdominal pain upper
6%
Pyrexia
6%
Vomiting
5%
Upper respiratory tract infection
1%
Campylobacter infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Open-label Treatment Phase
Aptensio XR
Placebo Comparator

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

EF004 Trial Design

7Treatment groups
Experimental Treatment
Group I: 60 mg Aptensio XRExperimental Treatment1 Intervention
60 mg methylphenidate, extended release
Group II: 50 mg Aptensio XRExperimental Treatment1 Intervention
50 mg methylphenidate, extended release
Group III: 40 mg Aptensio XRExperimental Treatment1 Intervention
40 mg methylphenidate, extended release
Group IV: 30 mg Aptensio XRExperimental Treatment1 Intervention
30 mg methylphenidate, extended release
Group V: 20 mg Aptensio XRExperimental Treatment1 Intervention
20 mg methylphenidate, extended release once daily
Group VI: 15 mg Aptensio XRExperimental Treatment1 Intervention
15 mg methylphenidate, extended release
Group VII: 10 mg Aptensio XRExperimental Treatment1 Intervention
10 mg methylphenidate, extended release
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylphenidate
FDA approved

Find a Location

Who is running the clinical trial?

Rhodes Pharmaceuticals, L.P.Lead Sponsor
10 Previous Clinical Trials
1,691 Total Patients Enrolled
9 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
1,619 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.
11 Previous Clinical Trials
1,611 Total Patients Enrolled
10 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
1,599 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~14 spots leftby Feb 2025