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A Pivotal Efficacy Trial to Evaluate HLD200 in Children With ADHD in a Classroom Setting
NCT02493777 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02493777
The ClinicalTrials.gov registry entry for NCT02493777 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ironshore Pharmaceuticals and Development, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02493777 reports 7 study locations spanning 5 distinct geographic areas — top geographies include Florida, Texas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02493777?
The interventions under investigation include: Placebo (DRUG), HLD200 methylphenidate hydrochloride (MPH) Capsules (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02493777?
This trial is sponsored by Ironshore Pharmaceuticals and Development, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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