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

Rhodes Pharmaceuticals

Status and phase: Unknown; Phase 4

Conditions: Attention Deficit Disorder With Hyperactivity

Treatments: Drug: Aptensio XR

Study type: Interventional

Funder types: Industry

Identifiers

NCT02677519

RP-BP-EF004

Details and patient eligibility

About

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)]

Enrollment: 120 estimated patients

Sex: All

Ages: 4 to 6 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 7 patient groups

10 mg Aptensio XR

Experimental group

Description:

10 mg methylphenidate, extended release

Treatment:

Drug: Aptensio XR

15 mg Aptensio XR

Experimental group

Description:

15 mg methylphenidate, extended release

Treatment:

Drug: Aptensio XR

20 mg Aptensio XR

Experimental group

Description:

20 mg methylphenidate, extended release once daily

Treatment:

Drug: Aptensio XR

30 mg Aptensio XR

Experimental group

Description:

30 mg methylphenidate, extended release

Treatment:

Drug: Aptensio XR

40 mg Aptensio XR

Experimental group

Description:

40 mg methylphenidate, extended release

Treatment:

Drug: Aptensio XR

50 mg Aptensio XR

Experimental group

Description:

50 mg methylphenidate, extended release

Treatment:

Drug: Aptensio XR

60 mg Aptensio XR

Experimental group

Description:

60 mg methylphenidate, extended release

Treatment:

Drug: Aptensio XR