Attention Deficit Disorder With HyperactivityPhase 4EF004NCT02677519
A 12-Month Open Label Safety Study of Aptensio XR® in Children Ages 4-5 Years Diagnosed With ADHD
A Phase 4 study testing Aptensio XR in people with Attention Deficit Disorder With Hyperactivity, run by Rhodes Pharmaceuticals, L.P. at 2 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Aptensio XR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2016to Sep 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Akwete Adjei, PhD contact
United States2 sites
Duke University Medical Center
Durham, North Carolina, 27705
Center for Psychiatry and Behavioral Medicine Inc.
Las Vegas, Nevada, 89128
About this study
Official title: 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.
Read more
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)]
- Being tested
- Aptensio XR
- Keywords
- ADHD, children, methylphenidate
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aptensio XRDrug
Also called Methylphenidate Extended Release
Orally-administered extended release formulation of methylphenidate; once daily dosing
| Study group | Role | What they receive |
|---|---|---|
| 10 mg Aptensio XR | Experimental | 10 mg methylphenidate, extended release Receives: Drug: Aptensio XR |
| 15 mg Aptensio XR | Experimental | 15 mg methylphenidate, extended release Receives: Drug: Aptensio XR |
| 20 mg Aptensio XR | Experimental | 20 mg methylphenidate, extended release once daily Receives: Drug: Aptensio XR |
| 30 mg Aptensio XR | Experimental | 30 mg methylphenidate, extended release Receives: Drug: Aptensio XR |
| 40 mg Aptensio XR | Experimental | 40 mg methylphenidate, extended release Receives: Drug: Aptensio XR |
| 50 mg Aptensio XR | Experimental | 50 mg methylphenidate, extended release Receives: Drug: Aptensio XR |
| 60 mg Aptensio XR | Experimental | 60 mg methylphenidate, extended release Receives: Drug: Aptensio XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events (TEAEs)
Incidence of TEAEs during maintenance phase
Measured: 12 month maintenance phase
Columbia Suicide Severity Rating Scale (C-SSRS)
Standardized assessment of suicide risk
Measured: 12 month maintenance phase
Vital signs
blood pressure, pulse, height, weight
Measured: 12 month maintenance phase
12-lead electrocardiogram
Measured: 12 month maintenance phase
Secondary outcomes (3)
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
Measured: 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).
Measured: 12 month maintenance phase
Connors Early Childhood Behavior-Parent Short [ConnorsEC BEH-P(S)]
Assesses behavior of preschool-aged children 2 to 6
Measured: 12 month maintenance phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startSep 2016
- Primary completionApr 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhodes Pharmaceuticals, L.P.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ann Childress, MD, Principal investigator, Center for Psychiatry And Behavioral Medicine Inc.Scott Kollins, MD, Principal investigator, Department of Psychiatry & Behavioral Sciences, Duke University, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677519
- Sponsor's protocol ID
- RP-BP-EF004
- Acronym
- EF004
- Status last verified
- Aug 2016
- First submitted
- 4 Feb 2016
- Last updated
- 25 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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.
PubMed 33892111
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02677519
- Acronym / sponsor ID
- EF004 / RP-BP-EF004
- Keywords
- ADHD, children, methylphenidate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Rhodes Pharmaceuticals, L.P.Industry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 9 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 10 mg Aptensio XR | Experimental | Drug: Aptensio XR10 mg methylphenidate, extended release |
| 15 mg Aptensio XR | Experimental | Drug: Aptensio XR15 mg methylphenidate, extended release |
| 20 mg Aptensio XR | Experimental | Drug: Aptensio XR20 mg methylphenidate, extended release once daily |
| 30 mg Aptensio XR | Experimental | Drug: Aptensio XR30 mg methylphenidate, extended release |
| 40 mg Aptensio XR | Experimental | Drug: Aptensio XR40 mg methylphenidate, extended release |
| 50 mg Aptensio XR | Experimental | Drug: Aptensio XR50 mg methylphenidate, extended release |
| 60 mg Aptensio XR | Experimental | Drug: Aptensio XR60 mg methylphenidate, extended release |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aptensio XRAlso: Methylphenidate Extended ReleaseOrally-administered extended release formulation of methylphenidate; once daily dosing | Drug | 10 mg Aptensio XR, 15 mg Aptensio XR, 20 mg Aptensio XR, 30 mg Aptensio XR, 40 mg Aptensio XR, 50 mg Aptensio XR, 60 mg Aptensio XR |
Primary outcome
Treatment-emergent adverse events (TEAEs)
Time frame: 12 month maintenance phase
Incidence of TEAEs during maintenance phase
Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: 12 month maintenance phase
Standardized assessment of suicide risk
Vital signs
Time frame: 12 month maintenance phase
blood pressure, pulse, height, weight
12-lead electrocardiogram
Time frame: 12 month maintenance phase
3 secondary outcomes
ADHD-RS-IV Preschool Version
Time frame: 12 month maintenance phase
Clinical Global Impressions-Severity Scale (CGI-S)
Time frame: 12 month maintenance phase
Connors Early Childhood Behavior-Parent Short [ConnorsEC BEH-P(S)]
Time frame: 12 month maintenance phase
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2016.
- Derived from this study: PubMed 33892111Childress 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Akwete Adjei, PhD contact
Ann Childress, MD principal investigator
Center for Psychiatry And Behavioral Medicine Inc.
Scott Kollins, MD principal investigator
Department of Psychiatry & Behavioral Sciences, Duke University, Durham, NC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aptensio XR in people with Attention Deficit Disorder With Hyperactivity, run by Rhodes Pharmaceuticals, L.P. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Akwete Adjei, PhD (akwete.adjei@pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent adverse events (TEAEs) (time frame: 12 month maintenance phase). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02677519, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2016.