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

Attention Deficit Disorder With Hyperactivity Clinical Trial

— EF004  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02677519
• Other study ID #: RP-BP-EF004
• Status: Not yet recruiting
• Phase: Phase 4
• First received: February 4, 2016
• Last updated: August 24, 2016
• Start date: September 2016
• Est. completion date: September 2017

Study information

• Verified date: August 2016
• Source: Rhodes Pharmaceuticals, L.P.
• Contact: Akwete Adjei, PhD
• Email: akwete.adjei[@]pharma.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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)]

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: September 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 6 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

Drug:
• Aptensio XR
Orally-administered extended release formulation of methylphenidate; once daily dosing

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	Center for Psychiatry and Behavioral Medicine Inc.	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Rhodes Pharmaceuticals, L.P.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-emergent adverse events (TEAEs)	Incidence of TEAEs during maintenance phase	12 month maintenance phase	Yes
Primary	Columbia Suicide Severity Rating Scale (C-SSRS)	Standardized assessment of suicide risk	12 month maintenance phase	Yes
Primary	Vital signs	blood pressure, pulse, height, weight	12 month maintenance phase	Yes
Primary	12-lead electrocardiogram		12 month maintenance phase	Yes
Secondary	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	12 month maintenance phase	No
Secondary	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).	12 month maintenance phase	No
Secondary	Connors Early Childhood Behavior-Parent Short [ConnorsEC BEH-P(S)]	Assesses behavior of preschool-aged children 2 to 6	12 month maintenance phase	No