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NCT02520388 · ClinicalTrials.gov registry record · Phase 3
A Pivotal Efficacy Trial to Evaluate HLD200 in Children With ADHD in a Naturalistic Setting
A Phase 3 study, sponsored by Ironshore Pharmaceuticals and Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 163
- Enrollment target
NCT02520388: Completed Phase 3 study, sponsored by Ironshore Pharmaceuticals and Development.
NCT02520388 is a Phase 3 study that has completed, run by Ironshore Pharmaceuticals and Development. The registered enrollment target is 163 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02520388, a Phase 3 study, has completed, sponsored by Ironshore Pharmaceuticals and Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 163 participants
- Enrollment target
Study Summary
This Phase 3 pivotal efficacy trial will examine the effects of HLD200 (methylphenidate) in patients aged 6-12 years with ADHD in a naturalistic setting. Following a screening/washout period (Visit 1), subjects will randomized to double-blind placebo or HLD200 for a period of 3 weeks (Visits 2-5) before assessing clinical study endpoints at last study visit.
Primary Outcome
The ADHD-RS-IV was developed to measure the behaviors of children with ADHD (DuPaul et al., 1998). The scale consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored in a range from 0 (reflecting no symptoms or a frequency of never or rarely) to 3 (reflecting severe symptoms or a frequency of almost always), with a range of total scores ranging from 0 to 54. In this study, a site clinican (required to be an MD, PhD, DO, licensed social worker, or any trained m
Interventions
- DRUG Placebo
- DRUG HLD200 methylphenidate hydrochloride (MPH) Capsules
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 163 participants |
| Start Date | 2015-08 |
| Est. Completion | 2016-05 |
| Phase | Phase 3 |
What the finished NCT02520388 record still lists
NCT02520388 is an interventional study that assigns participants to a tested intervention. The registered 163 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02520388 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02520388 about?
NCT02520388 is a clinical study titled "A Pivotal Efficacy Trial to Evaluate HLD200 in Children With ADHD in a Naturalistic Setting". This Phase 3 pivotal efficacy trial will examine the effects of HLD200 (methylphenidate) in patients aged 6-12 years with ADHD in a naturalistic setting. Following a screening/washout period (Visit 1), subjects will randomized to double-blind placebo or HLD200 for a period of 3 weeks (Visits 2-5) be...
What is the current status of trial NCT02520388?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 163 participants. The study started on 2015-08. Estimated completion is 2016-05.
What interventions are being tested in trial NCT02520388?
The interventions under investigation include: Placebo (DRUG), HLD200 methylphenidate hydrochloride (MPH) Capsules (DRUG).
Who is sponsoring clinical trial NCT02520388?
This trial is sponsored by Ironshore Pharmaceuticals and Development, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02520388's enrollment target sits among peer trials
163 1471st of 2000 higher than 527 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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