Attention Deficit Disorder With HyperactivityPhase 4EF003NCT02683265
A Flexible-Dose Titration Study of Aptensio XR in Children Ages 4 to Under 6 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
This randomized, double-blind, flexible-dose, placebo-controlled, parallel group study is designed to evaluate Aptensio XR® compared to placebo in preschool age children with 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?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Apr 2016to 27 Mar 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 ages 48 months to 68 months inclusive at time of consent
- Met Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for ADHD, combined, hyperactive/impulsive or inattentive presentation made during a clinical interview by an experienced clinician and confirmed with Kiddie-Sads-Present and Lifetime Version (K-SADS-PL)
- ADHD symptoms must have been present for at least 6 months
- Age- and sex-adjusted ratings of ≥ 90th percentile Total Score on the ADHD-RS-IV Preschool Version
- Score of < 65 on the Child Global Assessment Scale (CGAS)
- Must have had a CGI-S score of ≥ 4 at Visit 2 (subjects who were granted a waiver to bypass parental training, and did not have a Visit 2, were still qualified to continue in the study based on their CGI-S score at screening)
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- Estimated intelligence quotient (IQ) ≥ 80 on the Kaufman Brief Intelligence Test, 2nd edition (KBIT-2). If results from the KBIT-2 were deemed invalid because of significant ADHD symptomatology, the PI could submit additional documentation to support average cognitive functioning. This documentation could include progress reports from preschool or other previous testing. These exceptions were evaluated by the Medical Monitor and Study PIs on a case-by-case basis for inclusion.
- The subject had a parent or legal guardian who would give written informed consent for the subject to participate in the study
- Subject and parent or legal guardian must have been able to speak and understand English
- Subject must live with primary caretaker/rater and have been living with primary caretaker for at least 6 months
- Subject and parent/guardian must have been willing and able to comply with all requirements of the protocol
- Systolic and diastolic blood pressure below the 95th percentile for age and gender
Who cannot join
- The subject had a lack of response to a trial of adequate dose and duration of MPH or intolerance to previous methylphenidate (MPH) treatment
- The subject was using any other current psychotropic medication except clonidine, guanfacine, atomoxetine and/or stimulants or had taken an investigational drug in the 30 days prior to screening
- The subject had used monoamine oxidase inhibitors (MAOIs) within 14 days of the screening visit
- The subject planned to use prohibited drugs or agents at any point between the screening visit and the end of the study
- Use of anticonvulsants, antidepressants, or antipsychotics in the 30 days prior to screening
- The subject should not plan to start any additional psychotherapy outside of the trial during the duration of the study
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- The subject had a history of chronic vocal or motor tics or Tourette's syndrome
- The subject had any clinically significant ECG abnormalities at screening
- The subject had any major medical conditions that would have interfered with involvement in the study or could have been affected negatively by methylphenidate
- The subject had chronic medical illnesses including a seizure disorder (excluding a history of febrile seizures), severe hypertension, untreated thyroid disease, known structural cardiac abnormalities, serious arrhythmias, cardiomyopathy, glaucoma, or a family history of sudden death
- History (in the past 12 months) or presence of clinically-significant cardiovascular, cerebrovascular, renal, hepatic, gastrointestinal, pulmonary, immunological, hematological, endocrine, or neurological disease that in the opinion of the investigator could have put the subject at risk if he/she participated in the trial or which could have confounded study results
- Family history (parent or sibling) of structural cardiovascular disease
- Current or recent (past 12 months) history of drug abuse in someone living in the subject's home
- Current symptoms or history of major psychiatric illness (for example schizophrenia, psychosis, bipolar disorder, post-traumatic stress disorder, depression, severe anxiety disorder, obsessive compulsive disorder or autistic spectrum disorder) in addition to ADHD that required treatment with additional medication or, in the opinion of the PI, would have contraindicated study participation
- History or presence of suicidal ideation or significant self-injurious behavior
- The subject showed evidence of current physical, sexual, or emotional abuse
- Both biological parents of the subject had a history of bipolar disorder
Trial locations and contacts
2 sites in 1 country.
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 Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Titration Study of Aptensio XR® in Children Ages 4 to Under 6 Years Diagnosed With Attention Deficit-Hyperactivity Disorder (ADHD)
This randomized, double-blind, flexible-dose, placebo-controlled, parallel group study is designed to evaluate Aptensio XR® compared to placebo in preschool age children with ADHD. Male and female children ages 4 years, 0 months to 5 years, 8 months with a diagnosis of ADHD (combined, inattentive or hyperactive/impulsive) will be enrolled.
There will be 6 phases in this study: a screening phase of up to 4 weeks, which will include washout if applicable, an enrollment \& parent training phase lasting 2-4 weeks, an eligibility phase of up to 2 weeks to determine eligibility for the open-label phase, a 6-week open-label dose titration phase, a 2 week double-blind phase for Aptensio XR® responders, and a two-week follow-up call after study completion or early discontinuation to assess for ongoing adverse events and concomitant medications.
Read more
Up to 150 subjects will be enrolled in this trial to allow for subjects who improve significantly during the behavior training phase and drop-outs. Once 74 subjects have completed the double-blind phase, no additional subjects will be enrolled in the trial. Subjects who are already enrolled at that time will be allowed to complete the trial.
The primary objective of this study is to establish that an optimal dose of Aptensio XR® will result in a significant reduction in ADHD symptoms compared with placebo in children ages 4 to under 6 years.
- Being tested
- Aptensio XR, Placebo
- 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
Optimized dose of Aptensio XR (10, 15, 20, 30 or 40 mg) administered orally, once daily
PlaceboDrug
Also called Dose-matched placebo
Placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Aptensio XR | Experimental | Optimized dose of Aptensio XR (10, 15, 20, 30 or 40 mg Aptensio XR) Receives: Drug: Aptensio XR |
| Placebo comparator | Placebo comparator | Placebo capsules Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attention Deficit Hyperactivity Disorder Rating Scale - 4th Edition (ADHD-RS-IV) Preschool Version Total Score Change From End of Open Label Phase (Baseline) to End of Double Blind.
ADHD-RS-IV is 18-item scale incorporates each of the ADHD symptoms listed in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) regardless of assigned subtype. Scoring was based on the universally accepted symptom severity as recommended in the DSM-IV-TR manual on a 4-point scale: 0 = never or rarely, 1 = sometimes, 2 = often, and 3 = very often. The total score is the sum of the scores for all 18 items and could range from 0 (no impairment) to 54 (maximal impairment) for each administration per subject. Higher score means higher frequency and severity of symptoms.
Trained clinicians administered the questionnaire to parents. The ADHD-RS-IV Preschool Version was used to determine eligibility, optimal dosing and the efficacy of double blind treatment.
Measured: 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98.
Secondary outcomes (5)
Attention Deficit Hyperactivity Disorder Rating Scale - 4th Edition (ADHD-RS-IV) Preschool Version Hyperactivity-Impulsivity Subscale Score Change From End of Open Label Phase (Baseline) to End of Double Blind.
This 18-item scale incorporates each of the ADHD symptoms listed in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) regardless of assigned subtype. Scoring was based on the universally accepted symptom severity as recommended in the DSM-IV-TR manual on a 4-point scale: 0=never or rarely, 1=sometimes, 2=often, and 3=very often. The Hyperactivity-Impulsivity even items. The Hyperactivity-Impulsivity subscale score was the sum of the scores for the 9 even items and could range from 0 (no impairment) to 27 (maximal impairment) for each administration per subject. Higher score means higher frequency and severity of symptoms.
Trained clinicians administered the questionnaire to parents.
Measured: 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98.
Attention Deficit Hyperactivity Disorder Rating Scale - 4th Edition (ADHD-RS-IV) Preschool Version Inattention Subscale Score Change From End of Open Label Phase (Baseline) to End of Double Blind.
This 18-item scale incorporates each of the ADHD symptoms listed in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) regardless of assigned subtype. Scoring was based on the universally accepted symptom severity as recommended in the DSM-IV-TR manual on a 4-point scale: 0=never or rarely, 1=sometimes, 2=often, and 3=very often. The Inattention subscales were based upon the sum of the odd items. The Inattention subscale score was the sum of the scores for the 9 odd items and could range from 0 (no impairment) to 27 (maximal impairment) for each administration per subject. Higher score means higher frequency and severity of symptoms.
Trained clinicians administered the questionnaire to parents.
Measured: 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98.
Summary of Clinical Global Impression Scale of Severity (CGI-S) Score From End of Open Label Phase (Baseline) to End of Double Blind.
The scale provides a global rating of illness severity during the trial. The subject is rated relative to the clinician's past experience with other subjects who have the same diagnosis. The CGI-S scale is 1 question and rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill subjects). A lower value a better the outcome.
Measured: 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98.
Clinical Global Impression Scale of Improvement (CGI-I) Score at End of Double Blind Phase Relative to End of Open Label Phase (Baseline).
The scale provides a global rating of illness improvement during the trial. The subject is rated relative to the clinician's past experience with other subjects who have the same diagnosis. The CGI-I scale is 1 question, and rates improvement compared with a baseline visit using a 7-point scale. The range of responses are from 1 (very much improved) through 7 (very much worse).
A lower value is a better the outcome.
Measured: 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98.
Conners Early Childhood Behavior - Parent (Short) (EC BEH-P(S)) Change in T-score From End of Open Label Phase (Baseline) to End of Double Blind
Conners EC BEH-P(S) is an assessment tool used to obtain a parent's observations about his/her child's behavior. This tool is designed to assess a range of behavioral, emotional, \& social issues in young children. The tool consists of 47 items, responses to which are summarized in 6 behavioral scales \& 2 validity scales.
Items on Conners assessment are rated on a Likert scale ranging from 0-3. The ratings were converted to raw item scores. Raw item scores were grouped, standardized, and/or compared to lookup tables for interpretation. Assessments were presented as T-scores: item raw scores for a given scale are added together; this raw sum is compared to age- and gender-matched normative data and converted to a T-score. Higher scores indicate higher concerns. T-score is a standard score with a mean of 50 and standard deviation of 10. Note that Conners assessments do not use T-scores greater than 90; raw scores that produce extremely high T-scores are reported as ''T-score >= 90."
Measured: 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study start25 Apr 2016
- Primary completion2 Nov 2017
- Study completion27 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Titration Study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 158 participants (actual)
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.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683265
- Sponsor's protocol ID
- RP-BP-EF003
- Acronym
- EF003
- Status last verified
- Jan 2023
- First submitted
- 5 Feb 2016
- Last updated
- 21 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Titration Study of Aptensio XR® in Children Ages 4 to Under 6 Years Diagnosed With Attention Deficit-Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT02683265
- Acronym / sponsor ID
- EF003 / RP-BP-EF003
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Rhodes Pharmaceuticals, L.P.Industry (pharma, biotech, devices)
- Study start
- 25 Apr 2016 (actual)
- Primary completion
- 2 Nov 2017 (actual)
- Study completion
- 27 Mar 2018 (actual)
- First posted
- 17 Feb 2016 (estimated)
- Results
- Posted 21 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, double-blind, flexible-dose, placebo-controlled, parallel group study is designed to evaluate Aptensio XR® compared to placebo in preschool age children with ADHD. Male and female children ages 4 years, 0 months to 5 years, 8 months with a diagnosis of ADHD (combined, inattentive or hyperactive/impulsive) will be enrolled.
There will be 6 phases in this study: a screening phase of up to 4 weeks, which will include washout if applicable, an enrollment \& parent training phase lasting 2-4 weeks, an eligibility phase of up to 2 weeks to determine eligibility for the open-label phase, a 6-week open-label dose titration phase, a 2 week double-blind phase for Aptensio XR® responders, and a two-week follow-up call after study completion or early discontinuation to assess for ongoing adverse events and concomitant medications.
Up to 150 subjects will be enrolled in this trial to allow for subjects who improve significantly during the behavior training phase and drop-outs. Once 74 subjects have completed the double-blind phase, no additional subjects will be enrolled in the trial. Subjects who are already enrolled at that time will be allowed to complete the trial.
The primary objective of this study is to establish that an optimal dose of Aptensio XR® will result in a significant reduction in ADHD symptoms compared with placebo in children ages 4 to under 6 years.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Titration Study
| Arm | Type | Receives |
|---|---|---|
| Aptensio XR | Experimental | Drug: Aptensio XROptimized dose of Aptensio XR (10, 15, 20, 30 or 40 mg Aptensio XR) |
| Placebo comparator | Placebo comparator | Drug: PlaceboPlacebo capsules |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Male and female subjects ages 48 months to 68 months inclusive at time of consent
- Met Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for ADHD, combined, hyperactive/impulsive or inattentive presentation made during a clinical interview by an experienced clinician and confirmed with Kiddie-Sads-Present and Lifetime Version (K-SADS-PL)
- ADHD symptoms must have been present for at least 6 months
- Age- and sex-adjusted ratings of ≥ 90th percentile Total Score on the ADHD-RS-IV Preschool Version
- Score of < 65 on the Child Global Assessment Scale (CGAS)
Key exclusion criteria (17 listed)
- The subject had a lack of response to a trial of adequate dose and duration of MPH or intolerance to previous methylphenidate (MPH) treatment
- The subject was using any other current psychotropic medication except clonidine, guanfacine, atomoxetine and/or stimulants or had taken an investigational drug in the 30 days prior to screening
- The subject had used monoamine oxidase inhibitors (MAOIs) within 14 days of the screening visit
- The subject planned to use prohibited drugs or agents at any point between the screening visit and the end of the study
- Use of anticonvulsants, antidepressants, or antipsychotics in the 30 days prior to screening
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 releaseOptimized dose of Aptensio XR (10, 15, 20, 30 or 40 mg) administered orally, once daily | Drug | Aptensio XR |
| PlaceboAlso: Dose-matched placeboPlacebo capsules | Drug | Placebo comparator |
Primary outcome
Attention Deficit Hyperactivity Disorder Rating Scale - 4th Edition (ADHD-RS-IV) Preschool Version Total Score Change From End of Open Label Phase (Baseline) to End of Double Blind.
Time frame: 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98.
ADHD-RS-IV is 18-item scale incorporates each of the ADHD symptoms listed in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) regardless of assigned subtype. Scoring was based on the universally accepted symptom severity as recommended in the DSM-IV-TR manual on a 4-point scale: 0 = never or rarely, 1 = sometimes, 2 = often, and 3 = very often. The total score is the sum of the scores for all 18 items and could range from 0 (no impairment) to 54 (maximal impairment) for each administration per subject. Higher score means higher frequency and severity of symptoms. Trained clinicians administered the questionnaire to parents. The ADHD-RS-IV Preschool Version was used to determine eligibility, optimal dosing and the efficacy of double blind treatment.
5 secondary outcomes
Attention Deficit Hyperactivity Disorder Rating Scale - 4th Edition (ADHD-RS-IV) Preschool Version Hyperactivity-Impulsivity Subscale Score Change From End of Open Label Phase (Baseline) to End of Double Blind.
Time frame: 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98.
Attention Deficit Hyperactivity Disorder Rating Scale - 4th Edition (ADHD-RS-IV) Preschool Version Inattention Subscale Score Change From End of Open Label Phase (Baseline) to End of Double Blind.
Time frame: 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98.
Summary of Clinical Global Impression Scale of Severity (CGI-S) Score From End of Open Label Phase (Baseline) to End of Double Blind.
Time frame: 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98.
Clinical Global Impression Scale of Improvement (CGI-I) Score at End of Double Blind Phase Relative to End of Open Label Phase (Baseline).
Time frame: 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98.
Conners Early Childhood Behavior - Parent (Short) (EC BEH-P(S)) Change in T-score From End of Open Label Phase (Baseline) to End of Double Blind
Time frame: 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ann Childress, MD principal investigator
Center for Psychiatry And Behavioral Medicine Inc.
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 12 inclusion and 17 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: finished, as of the sponsor's last update on 21 Feb 2023. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 21 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attention Deficit Hyperactivity Disorder Rating Scale - 4th Edition (ADHD-RS-IV) Preschool Version Total Score Change From End of Open Label Phase (Baseline) to End of Double Blind. (time frame: 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2023.