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NCT02493777 · ClinicalTrials.gov registry record · Phase 3
A Pivotal Efficacy Trial to Evaluate HLD200 in Children With ADHD in a Classroom Setting
A Phase 3 study of Attention Deficit Hyperactivity Disorder, sponsored by Ironshore Pharmaceuticals and Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 125
- Enrollment target
- 7
- Study locations
NCT02493777: Completed Phase 3 study of Attention Deficit Hyperactivity Disorder, sponsored by Ironshore Pharmaceuticals and Development.
NCT02493777 is a Phase 3 study of Attention Deficit Hyperactivity Disorder that has completed, run by Ironshore Pharmaceuticals and Development. The registered enrollment target is 125 participants, below the 215-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (42% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02493777, a Phase 3 study of Attention Deficit Hyperactivity Disorder, has completed, sponsored by Ironshore Pharmaceuticals and Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 125 participants
- Enrollment target
- 7
- Study locations
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 laboratory classroom setting. This study has a 6-week open-label treatment optimization period followed by a one week randomized, double-blind, placebo-controlled test phase.
Primary Outcome
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. Each individual item is rated on a 7-point scale from 0 (normal, no impairment) to 6 (maximal impairment). When all individual item scores are
Conditions Studied
Interventions
- DRUG Placebo
- DRUG HLD200 methylphenidate hydrochloride (MPH) Capsules
Study Locations (7)
Florida
- Florida Clinical Research Center, LLC - Bradenton
- Florida Clinical Research Center, LLC - Maitland
Texas
- Bayou City Research, Ltd - Houston
- Westex Clinical Investigations - Lubbock
California
- AVIDA Inc. - Newport Beach
Massachusetts
- South Shore Psychiatric Services, PC - Marshfield
Nevada
- Center for Psychiatry and Behavioral Medicine, Inc. - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2015-07 |
| Est. Completion | 2016-03 |
| Phase | Phase 3 |
What the finished NCT02493777 record still lists
NCT02493777 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, below the 215-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (42% lower).
The record links to 1 condition, with Attention Deficit Hyperactivity Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02493777 lists 7 locations in 5 states (Florida, Texas, California).
Frequently Asked Questions
What is clinical trial NCT02493777 about?
NCT02493777 is a clinical study titled "A Pivotal Efficacy Trial to Evaluate HLD200 in Children With ADHD in a Classroom Setting". This Phase 3 pivotal efficacy trial will examine the effects of HLD200 (methylphenidate) in patients aged 6-12 years with ADHD in a laboratory classroom setting. This study has a 6-week open-label treatment optimization period followed by a one week randomized, double-blind, placebo-controlled test ...
What is the current status of trial NCT02493777?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 125 participants. The study started on 2015-07. Estimated completion is 2016-03.
What conditions does trial NCT02493777 study?
This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder.
What interventions are being tested in trial NCT02493777?
The interventions under investigation include: Placebo (DRUG), HLD200 methylphenidate hydrochloride (MPH) Capsules (DRUG).
Who is sponsoring clinical trial NCT02493777?
This trial is sponsored by Ironshore Pharmaceuticals and Development, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02493777 being conducted?
This trial has 7 study locations across California, Florida, Massachusetts, Nevada, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02493777's enrollment target sits among peer trials
125 40th of 102 higher than 63 of 102 other Attention Deficit Hyperactivity Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Attention Deficit Hyperactivity Disorder 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.
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