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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 is a Phase 3 study that has completed, run by Ironshore Pharmaceuticals and Development. The registered enrollment target is 163 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02520388
The ClinicalTrials.gov registry entry for NCT02520388 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 163 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 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02520388 reports 0 study locations.
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.
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