NCT02677519: EF004

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)

Status unknown Phase 4 Last updated 24 August 2016

What this trial tests

Phase 4 trial testing Aptensio XR in Attention Deficit Disorder With Hyperactivity in 120 participants. Status unknown.

Timeline

1 September 2016

Primary endpoint
1 April 2017

1 September 2017

Quick facts

Lead sponsor	Rhodes Pharmaceuticals, L.P.
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	120
Start date	1 September 2016
Primary completion	1 April 2017
Estimated completion	1 September 2017
Sites	2 locations across United States

Drugs / interventions tested

• Aptensio XR — full drug profile →

Conditions studied

• Attention Deficit Disorder With Hyperactivity — all drugs for Attention Deficit Disorder With Hyperactivity →

Sponsor

Rhodes Pharmaceuticals, L.P. — full company profile →

Who can join

Adults 4 to 6, any sex, with Attention Deficit Disorder With Hyperactivity. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Treatment-emergent adverse events (TEAEs)
  Time frame: 12 month maintenance phase
  Incidence of TEAEs during maintenance phase
• Columbia Suicide Severity Rating Scale (C-SSRS)
  Time frame: 12 month maintenance phase
  Standardized assessment of suicide risk
• Vital signs
  Time frame: 12 month maintenance phase
  blood pressure, pulse, height, weight
• 12-lead electrocardiogram
  Time frame: 12 month maintenance phase

Sponsor's own description

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 \[Conners EC BEH-P(S)\]

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Diagnosis and Treatment Options for Preschoolers with Attention-Deficit/Hyperactivity Disorder.
   Wigal S, Chappell P, Palumbo D, Lubaczewski S, et al · · 2020 · cited 14× · PMID 31967914 · DOI 10.1089/cap.2019.0116
2. Long-Term Treatment With Extended-Release Methylphenidate Treatment in Children Aged 4 to <6 Years.
   Childress AC, Foehl HC, Newcorn JH, Faraone SV, et al · · 2022 · cited 8× · PMID 33892111 · DOI 10.1016/j.jaac.2021.03.019