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A 12-Month Open Label Safety Study of Aptensio XR® in Children Ages 4-5 Years Diagnosed With ADHD (EF004)

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.
 
ClinicalTrials.gov Identifier: NCT02677519
Recruitment Status : Unknown
Verified August 2016 by Rhodes Pharmaceuticals, L.P..
Recruitment status was:  Not yet recruiting
First Posted : February 9, 2016
Last Update Posted : August 25, 2016
Sponsor:
Information provided by (Responsible Party):
Rhodes Pharmaceuticals, L.P.

Brief 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)]

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : September 2016
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : September 2017


Arm Intervention/treatment
Experimental: 10 mg Aptensio XR
10 mg methylphenidate, extended release
Drug: Aptensio XR
Orally-administered extended release formulation of methylphenidate; once daily dosing
Other Name: Methylphenidate Extended Release

Experimental: 15 mg Aptensio XR
15 mg methylphenidate, extended release
Drug: Aptensio XR
Orally-administered extended release formulation of methylphenidate; once daily dosing
Other Name: Methylphenidate Extended Release

Experimental: 20 mg Aptensio XR
20 mg methylphenidate, extended release once daily
Drug: Aptensio XR
Orally-administered extended release formulation of methylphenidate; once daily dosing
Other Name: Methylphenidate Extended Release

Experimental: 30 mg Aptensio XR
30 mg methylphenidate, extended release
Drug: Aptensio XR
Orally-administered extended release formulation of methylphenidate; once daily dosing
Other Name: Methylphenidate Extended Release

Experimental: 40 mg Aptensio XR
40 mg methylphenidate, extended release
Drug: Aptensio XR
Orally-administered extended release formulation of methylphenidate; once daily dosing
Other Name: Methylphenidate Extended Release

Experimental: 50 mg Aptensio XR
50 mg methylphenidate, extended release
Drug: Aptensio XR
Orally-administered extended release formulation of methylphenidate; once daily dosing
Other Name: Methylphenidate Extended Release

Experimental: 60 mg Aptensio XR
60 mg methylphenidate, extended release
Drug: Aptensio XR
Orally-administered extended release formulation of methylphenidate; once daily dosing
Other Name: Methylphenidate Extended Release




Primary Outcome Measures :
  1. Treatment-emergent adverse events (TEAEs) [ Time Frame: 12 month maintenance phase ]
    Incidence of TEAEs during maintenance phase

  2. Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 12 month maintenance phase ]
    Standardized assessment of suicide risk

  3. Vital signs [ Time Frame: 12 month maintenance phase ]
    blood pressure, pulse, height, weight

  4. 12-lead electrocardiogram [ Time Frame: 12 month maintenance phase ]

Secondary Outcome Measures :
  1. ADHD-RS-IV Preschool Version [ Time Frame: 12 month maintenance phase ]
    Investigator administered Attention-Deficit/Hyperactivity Disorder Rating Scale Preschool Version (ADHD-RS-IV Preschool Version) to assess ADHD severity and functioning

  2. Clinical Global Impressions-Severity Scale (CGI-S) [ Time Frame: 12 month maintenance phase ]
    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).

  3. Connors Early Childhood Behavior-Parent Short [ConnorsEC BEH-P(S)] [ Time Frame: 12 month maintenance phase ]
    Assesses behavior of preschool-aged children 2 to 6



Information from the National Library of Medicine

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

Inclusion Criteria:

  • 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.

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 ClinicalTrials.gov identifier (NCT number): NCT02677519


Contacts
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Contact: Akwete Adjei, PhD akwete.adjei@pharma.com

Locations
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United States, Nevada
Center for Psychiatry and Behavioral Medicine Inc.
Las Vegas, Nevada, United States, 89128
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Rhodes Pharmaceuticals, L.P.
Investigators
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Principal Investigator: Ann Childress, MD Center for Psychiatry And Behavioral Medicine Inc.
Principal Investigator: Scott Kollins, MD Department of Psychiatry & Behavioral Sciences, Duke University, Durham, NC

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Responsible Party: Rhodes Pharmaceuticals, L.P.
ClinicalTrials.gov Identifier: NCT02677519    
Other Study ID Numbers: RP-BP-EF004
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: August 25, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Rhodes Pharmaceuticals, L.P.:
ADHD
children
methylphenidate
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
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