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NCT02255513 · ClinicalTrials.gov registry record · Phase 3

A Trial Evaluating the Efficacy and Safety of HLD200 in Children With ADHD

A Phase 3 study, sponsored by Ironshore Pharmaceuticals and Development.

Completed
Registry status
Phase 3
Development phase
43
Enrollment target

NCT02255513: Completed Phase 3 study, sponsored by Ironshore Pharmaceuticals and Development.

NCT02255513 is a Phase 3 study that has completed, run by Ironshore Pharmaceuticals and Development. The registered enrollment target is 43 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02255513, a Phase 3 study, has completed, sponsored by Ironshore Pharmaceuticals and Development.

COMPLETED
Registry status
Phase 3
Development phase
43 participants
Enrollment target

Study Summary

This study will examine the efficacy and safety of HLD200 in patients age 6-12 years with ADHD using a classroom study design.

Primary Outcome

Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP) Combined Scores - Average of 8:00 am to 4:00 pm assessments from the laboratory school day. The SKAMP is a validated, 13-item, observer-rated scale designed to assess the level of impairment of classroom-observed behaviors (Wigal and Wigal, 2006). Items 1 through 4 assess subject attention; items 5 through 8 assess deportment; items 9 through 11 assess quality of work; while items 12 and 13 assess subject compliance with teacher/classroom rules

Interventions

  • DRUG Placebo
  • DRUG HLD200

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2014-05
Est. Completion 2014-10
Phase Phase 3

What the finished NCT02255513 record still lists

NCT02255513 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02255513 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02255513 about?

NCT02255513 is a clinical study titled "A Trial Evaluating the Efficacy and Safety of HLD200 in Children With ADHD". This study will examine the efficacy and safety of HLD200 in patients age 6-12 years with ADHD using a classroom study design.

What is the current status of trial NCT02255513?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 43 participants. The study started on 2014-05. Estimated completion is 2014-10.

What interventions are being tested in trial NCT02255513?

The interventions under investigation include: Placebo (DRUG), HLD200 (DRUG).

Who is sponsoring clinical trial NCT02255513?

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 NCT02255513's enrollment target sits among peer trials

43 1876th of 2000 higher than 124 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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Source: ClinicalTrials.gov NCT02255513, the US trial registry maintained by the National Library of Medicine. NCT02255513 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.