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A Flexible-Dose Titration Study of Aptensio XR in Children Ages 4 to Under 6 Years Diagnosed With ADHD (EF003)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02683265
Recruitment Status : Unknown
Verified February 2016 by Rhodes Pharmaceuticals, L.P..
Recruitment status was:  Not yet recruiting
First Posted : February 17, 2016
Last Update Posted : February 17, 2016
Information provided by (Responsible Party):
Rhodes Pharmaceuticals, L.P.

Brief 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. 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

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Drug: Aptensio XR Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : March 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Aptensio XR
Optimized dose of Aptensio XR (10, 15, 20, 30 or 40 mg Aptensio XR)
Drug: Aptensio XR
Optimized dose of Aptensio XR (10, 15, 20, 30 or 40 mg) administered orally, once daily
Other Name: methylphenidate, extended release

Placebo Comparator: Placebo comparator
Placebo capsules
Drug: Placebo
Placebo capsules
Other Name: Dose-matched placebo

Primary Outcome Measures :
  1. ADHD-RS-IV Total Score [ Time Frame: At visit 8 (study day 49), 9,10, 11, 12, and 13 (study day 84). Change in score between visit 8 (study day 49) and 13 (study day 84) will be presented ]
    Change in ADHD-RS-IV score during the double blind phase, i.e. the change from end of open label phase to end of double blind phase

Secondary Outcome Measures :
  1. CGI-I score [ Time Frame: At visit 8 (study day 49), 9,10, 11, 12, and 13 (study day 84). Change in score between visit 8 (study day 49) and 13 (study day 84) will be presented ]
    change in clinical global impressions - improvement score during double-blind phase

  2. CGI-S score [ Time Frame: At visit 7 (study day 42) and and visit 13 (study day 84) ]
    change in Clinical Global Impressions - severity Scale during double blind phase

Other Outcome Measures:
  1. Vital signs [ Time Frame: Assessed at study days 49, 56, 63, 70, 77 and 84 during open label treatment. Change vs. baseline will be presented ]
  2. C-SSRS [ Time Frame: Assessed at study days 49, 56, 63, 70, 77 and 84 during open label treatment. Change vs. baseline will be presented ]
    Columbia Suicide Severity Rating Scale

  3. CSHQ [ Time Frame: Assessed at study days 49, 56, 63, 70, 77 and 84 during open label treatment. Change vs. baseline will be presented ]
    change in child sleep habits questionnaire (CSHQ) score during double-blind phase (between visit 8 and 13)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and female subjects ages 48 months to 68 months inclusive at time of consent
  • Meets 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 six months
  • Age- and sex-adjusted ratings of ≥ 90th percentile Total Score on the ADHD-RS-IV Preschool Version (rated over past six months)
  • Score of <65 on the Child Global Assessment Scale
  • Must have a score of ≥4 on the Clinical Global Impressions Severity (CGI-S) at Visit 2
  • Estimated IQ ≥80 on the Kaufman Brief Intelligence Test, Second Edition (KBIT-2)
  • The subject has a parent or legal guardian who will give written informed consent for the subject to participate in the study
  • Subject and parent or legal guardian must be 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 or legally authorized representative must be willing and able to comply with all requirements of this protocol
  • Systolic and diastolic blood pressure below the 95th percentile for age and gender

Exclusion Criteria:

  • The subject has had a lack of response to a trial of adequate dose and duration of MPH or intolerance to previous MPH treatment
  • The subject is using any other current psychotropic medication except clonidine, guanfacine, atomoxetine and /or stimulants or has taken an investigational drug in the 30 days prior to screening
  • The subject has used monoamine oxidase inhibitors within 14 days of the screening visit
  • The subject plans 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 start any additional psychotherapy outside of the trial during the duration of the study
  • The subject has a history of chronic vocal or motor tics or Tourette's syndrome
  • The subject has any clinically significant ECG abnormalities at screening
  • The subject has any major medical conditions that would interfere with involvement in a study or could be affected negatively by methylphenidate
  • The subject has 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 put the subject at risk if he/she participates in the trial or could confound 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 requires treatment with additional medication or, in the opinion of the PI, would contraindicate study participation History or presence of suicidal ideation or significant self-injurious behavior
  • The subject shows evidence of current physical, sexual, or emotional abuse
  • Both biological parents of the subject have a history of bipolar disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02683265

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Contact: Akwete Adjei, PhD 401-202-9408
Contact: Peter Haddock, PhD 401-202-9088

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United States, Nevada
Center for Psychiatry and Behavioral Medicine Inc.
Las Vegas, Nevada, United States, 89128
Contact: Ann Childress    702-838-0742   
Contact: Nivole Schlaft    702-838-0742   
Principal Investigator: Ann Childress         
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Contact: Scott Kollins    919-681-0014   
Contact: Nilda Itchon-Ramos    919-681-0032   
Principal Investigator: Scott Kollins         
Sponsors and Collaborators
Rhodes Pharmaceuticals, L.P.
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Principal Investigator: Ann Childress, MD Center for Psychiatry And Behavioral Medicine Inc.
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Responsible Party: Rhodes Pharmaceuticals, L.P. Identifier: NCT02683265    
Other Study ID Numbers: RP-BP-EF003
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents