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NCT02884544 · ClinicalTrials.gov registry record · Phase 2

A Study of Delayed and Extended Release Formulation of Dextroamphetamine Sulfate (HLD100) in Children With ADHD

A Phase 2 study, sponsored by Ironshore Pharmaceuticals and Development.

Completed
Registry status
Phase 2
Development phase
22
Enrollment target

NCT02884544: Completed Phase 2 study, sponsored by Ironshore Pharmaceuticals and Development.

NCT02884544 is a Phase 2 study that has completed, run by Ironshore Pharmaceuticals and Development. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02884544, a Phase 2 study, has completed, sponsored by Ironshore Pharmaceuticals and Development.

COMPLETED
Registry status
Phase 2
Development phase
22 participants
Enrollment target

Study Summary

The phase 2 study will evaluate the safety, tolerability and efficacy of HLD100 at steady state (following up to 5 weeks of treatment) in children using an outpatient, single-center, open-label, flexible dose-escalation study design.

Primary Outcome

Primary outcome is the determination of the dose achieving optimal clinical effect in a safe and tolerable manner

Interventions

  • DRUG HLD100

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2016-08
Est. Completion 2016-12-27
Phase Phase 2

What the finished NCT02884544 record still lists

NCT02884544 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 1 intervention - of which HLD100 is the first listed.

NCT02884544 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02884544 about?

NCT02884544 is a clinical study titled "A Study of Delayed and Extended Release Formulation of Dextroamphetamine Sulfate (HLD100) in Children With ADHD". The phase 2 study will evaluate the safety, tolerability and efficacy of HLD100 at steady state (following up to 5 weeks of treatment) in children using an outpatient, single-center, open-label, flexible dose-escalation study design.

What is the current status of trial NCT02884544?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2016-08. Estimated completion is 2016-12-27.

What interventions are being tested in trial NCT02884544?

The interventions under investigation include: HLD100 (DRUG).

Who is sponsoring clinical trial NCT02884544?

This trial is sponsored by Ironshore Pharmaceuticals and Development, which has 6 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02884544's enrollment target sits among peer trials

22 1790th of 2000 higher than 207 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT02884544, the US trial registry maintained by the National Library of Medicine. NCT02884544 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.