Safety and Tolerability Study of SPD489 in Preschool Children Aged 4-5 Years, Diagnosed With Attention-deficit/Hyperactivity Disorder
Public ClinicalTrials.gov record NCT02466386. 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
A Phase 3, Open-label, Multicenter, 12-Month Safety and Tolerability Study of SPD489 in Preschool Children Aged 4-5 Years Diagnosed With Attention-deficit / Hyperactivity Disorder
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the long-term safety of SPD489 administered as a daily morning dose (5, 10, 15, 20, and 30 mg/day) in preschool children diagnosed with Attention-deficit/Hyperactivity Disorder (ADHD).
Study identification
- NCT ID
- NCT02466386
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 113 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 4 Years to 5 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 21, 2015 (Actual)
- Primary completion
- Jan 3, 2020 (Actual)
- Completion
- Jan 3, 2020 (Actual)
- Last update posted
- Mar 5, 2021
2015 – 2020
United States locations
- U.S. sites
- 50
- U.S. states
- 23
- U.S. cities
- 44
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Harmonex, Inc | Dothan | Alabama | 36303 | — |
| Preferred Research Partners, Inc. | Little Rock | Arkansas | 72211 | — |
| Sun Valley Research Center | Imperial | California | 92251 | — |
| Alliance for Wellness d/b/a Alliance for Research | Long Beach | California | 90807 | — |
| AVIDA | Newport Beach | California | 92660 | — |
| Asclepes Research | Panorama City | California | 91402 | — |
| Psychiatric Centers at San Diego | San Diego | California | 92108 | — |
| University of California | San Francisco | California | 94143 | — |
| Elite Clinical Trials, Inc | Wildomar | California | 92595 | — |
| Avail Clinical Research, LLC | DeLand | Florida | 32720 | — |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | — |
| Medical Research Group of Central Florida | Orange City | Florida | 32763 | — |
| Clinical Neuroscience Solutions | Orlando | Florida | 32801 | — |
| APG Research, LLC | Orlando | Florida | 32803 | — |
| University of South Florida | St. Petersburg | Florida | 33701 | — |
| University of South Florida Department Of Psychiatry | Tampa | Florida | 33613 | — |
| iResearch Atlanta LLC | Decatur | Georgia | 30030 | — |
| Lake Charles Clinical Trials | Lake Charles | Louisiana | 70629 | — |
| Kennedy Krieger Institute | Baltimore | Maryland | 21205 | — |
| Rochester Center for Behavioral Medicine | Rochester Hills | Michigan | 48306 | — |
| Clinical Neurophysiology Services | Sterling Heights | Michigan | 48314 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| Premier Psychiatric Reseach Institute, LLC | Lincoln | Nebraska | 68526 | — |
| Center For Psychiatry and Behavioral Medicine In | Las Vegas | Nevada | 89128 | — |
| Jersey Shore University Medical Center (JSUMC) | Neptune City | New Jersey | 7753 | — |
| Manhattan Behavioral Medicine | New York | New York | 10036 | — |
| University of Rochester | Rochester | New York | 14627 | — |
| Duke Child and Family Center | Durham | North Carolina | 27705 | — |
| University of Cincinnati | Cincinnati | Ohio | 45219 | — |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | — |
| Pediatric Associates of Fairfield, Inc. | Fairfield | Ohio | 45014 | — |
| IPS Research Company | Oklahoma City | Oklahoma | 73103 | — |
| Oklahoma Clinical Research Center | Oklahoma City | Oklahoma | 73112 | — |
| Paradigm Research Professionals | Oklahoma City | Oklahoma | 73118 | — |
| Cutting Edge Research Group | Oklahoma City | Oklahoma | 73120 | — |
| Cyn3rgy Research Center | Gresham | Oregon | 97030 | — |
| Rainbow Research Inc | Barnwell | South Carolina | 29812 | — |
| Carolina Clinical Trials, Inc. | Charleston | South Carolina | 29407 | — |
| Coastal Carolina Research | Mt. Pleasant | South Carolina | 29464 | — |
| Clinical Neuroscience Solutions, Inc | Memphis | Tennessee | 38119 | — |
| BioBehavioral Research of Austin | Austin | Texas | 78759 | — |
| Bayou City Research Limited | Houston | Texas | 77007 | — |
| BI Research Center | Houston | Texas | 77084 | — |
| Red Oak Psychiatry Associates | Houston | Texas | 77090 | — |
| Road Runner Research | San Antonio | Texas | 78249 | — |
| Family Psychiatry of the Woodlands | The Woodlands | Texas | 77381 | — |
| Ericksen Research and Development | Clinton | Utah | 84015 | — |
| Clinical Research Partners, LLC | Petersburg | Virginia | 23805 | — |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | — |
| Seattle Childrens 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 NCT02466386, 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 Mar 5, 2021 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02466386 live on ClinicalTrials.gov.