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NCT02683265 · ClinicalTrials.gov registry record · Phase 4
A Flexible-Dose Titration Study of Aptensio XR in Children Ages 4 to Under 6 Years Diagnosed With ADHD
A Phase 4 study, sponsored by Rhodes Pharmaceuticals, L.P..
- Completed
- Registry status
- Phase 4
- Development phase
- 158
- Enrollment target
NCT02683265: Completed Phase 4 study, sponsored by Rhodes Pharmaceuticals, L.P..
NCT02683265 is a Phase 4 study that has completed, run by Rhodes Pharmaceuticals, L.P.. The registered enrollment target is 158 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02683265, a Phase 4 study, has completed, sponsored by Rhodes Pharmaceuticals, L.P..
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 158 participants
- Enrollment target
Study 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.
Primary Outcome
ADHD-RS-IV is 18-item scale incorporates each of the ADHD symptoms listed in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) regardless of assigned subtype. Scoring was based on the universally accepted symptom severity as recommended in the DSM-IV-TR manual on a 4-point scale: 0 = never or rarely, 1 = sometimes, 2 = often, and 3 = very often. The total score is the sum of the scores for all 18 items and could range from 0 (no impairment) to 54 (
Interventions
- DRUG Placebo
- DRUG Aptensio XR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2016-04-25 |
| Est. Completion | 2018-03-27 |
| Phase | Phase 4 |
What the finished NCT02683265 record still lists
NCT02683265 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02683265 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02683265 about?
NCT02683265 is a clinical study titled "A Flexible-Dose Titration Study of Aptensio XR in Children Ages 4 to Under 6 Years Diagnosed With ADHD". 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...
What is the current status of trial NCT02683265?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 158 participants. The study started on 2016-04-25. Estimated completion is 2018-03-27.
What interventions are being tested in trial NCT02683265?
The interventions under investigation include: Placebo (DRUG), Aptensio XR (DRUG).
Who is sponsoring clinical trial NCT02683265?
This trial is sponsored by Rhodes Pharmaceuticals, L.P., which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02683265's enrollment target sits among peer trials
158 516th of 2000 higher than 1,482 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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