A Pivotal Efficacy Trial to Evaluate HLD200 in Children With ADHD in a Naturalistic Setting
Public ClinicalTrials.gov record NCT02520388. 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 DBRCT Parallel Group Study to Evaluate Safety & Efficacy of Evening-dosed HLD200, a Novel Delayed & Extended Release Formulation (DELEXIS) of MPH HCl, on Post-waking, Early Morning Function in Children Aged 6-12 With ADHD
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 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.
Study identification
- NCT ID
- NCT02520388
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 163 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
- Aug 2015 (Type not available)
- Primary completion
- Apr 2016 (Actual)
- Completion
- May 2016 (Actual)
- Last update posted
- Jul 23, 2021
2015 – 2016
United States locations
- U.S. sites
- 21
- U.S. states
- 9
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| AVIDA | Newport Beach | California | 92660 | — |
| Florida Clinical Research Center, LLC | Bradenton | Florida | 34201 | — |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | — |
| Clinical Neuroscience Solutions, Inc | Jacksonville | Florida | 32256 | — |
| Florida Clinical Research Center, LLC | Maitland | Florida | 32751 | — |
| Scientific Clinical Research, Inc. | North Miami | Florida | 33161 | — |
| Medical Research Group of Central Florida | Orange City | Florida | 32763 | — |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32801 | — |
| QPS MRA, dba Miami Research Associates, LLC | South Miami | Florida | 33143 | — |
| Children's Developmental Center, P.A. | Winter Park | Florida | 32792 | — |
| Pedia Research, LLC | Owensboro | Kentucky | 42301 | — |
| Duke University Medical Center, Duke Child and Family Study Center | Durham | North Carolina | 27705 | — |
| IPS Research Company | Oklahoma City | Oklahoma | 73103 | — |
| Cutting Edge Research Group | Oklahoma City | Oklahoma | 73116 | — |
| Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee | 38119 | — |
| Bayou City Research, Ltd | Houston | Texas | 77007 | — |
| Red Oak Psychiatry Associates, PA | Houston | Texas | 77090 | — |
| Westex Clinical Investigations | Lubbock | Texas | 79423 | — |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | — |
| Ericksen Research and Development | Clinton | Utah | 84015 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
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 NCT02520388, 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 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02520388 live on ClinicalTrials.gov.