A Pivotal Efficacy Trial to Evaluate HLD200 in Children With ADHD in a Classroom Setting
Public ClinicalTrials.gov record NCT02493777. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Ph 3 Multicenter OL Treatment-optimized RDBPC Forced-withdrawal, Parallel Grp Study to Evaluate Safety & Efficacy of Evening Dosed HLD200, a Novel DR/ER Formulation (DELEXIS) of MPH HCl in Children Aged 6-12 With ADHD in Classroom Setting
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02493777
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 125 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Years to 12 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 2015 (Type not available)
- Primary completion
- Feb 2016 (Actual)
- Completion
- Mar 2016 (Actual)
- Last update posted
- Jul 23, 2021
2015 – 2016
United States locations
- U.S. sites
- 7
- U.S. states
- 5
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| AVIDA Inc. | Newport Beach | California | 92660 | — |
| Florida Clinical Research Center, LLC | Bradenton | Florida | 34201 | — |
| Florida Clinical Research Center, LLC | Maitland | Florida | 32751 | — |
| South Shore Psychiatric Services, PC | Marshfield | Massachusetts | 02050 | — |
| Center for Psychiatry and Behavioral Medicine, Inc. | Las Vegas | Nevada | 89128 | — |
| Bayou City Research, Ltd | Houston | Texas | 77007 | — |
| Westex Clinical Investigations | Lubbock | Texas | 79423 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02493777, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 23, 2021 · Synced Oct 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02493777 live on ClinicalTrials.gov.