Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD)
Public ClinicalTrials.gov record NCT03260205. 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, Randomized, Double-blind, Multicenter, Parallel-group, Placebo-controlled, Fixed-Dose Safety and Efficacy Study of SPD489 Compared With Placebo in Preschool Children Aged 4-5 Years 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 determine if an investigational treatment is effective in improving the total score on the ADHD-RS-IV Preschool Version in children 4-5 years old diagnosed with ADHD.
Study identification
- NCT ID
- NCT03260205
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 199 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
- Sep 6, 2017 (Actual)
- Primary completion
- Oct 23, 2018 (Actual)
- Completion
- Oct 23, 2018 (Actual)
- Last update posted
- Jun 8, 2021
2017 – 2018
United States locations
- U.S. sites
- 48
- U.S. states
- 21
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Harmonex, Inc | Dothan | Alabama | 36303 | — |
| Preferred Research Partners, Inc | Little Rock | Arkansas | 72211 | — |
| CMB Clinical Trials | Colton | California | 92324 | — |
| Sun Valley Research Center | Imperial | California | 92251 | — |
| Alliance for Wellness d/b/a Alliance for Research | Long Beach | California | 90807 | — |
| Asclepes Research | Panorama City | California | 91402 | — |
| Psychiatric Centers at San Diego | San Diego | California | 92108 | — |
| UCSF Dept of Psychiatry | San Francisco | California | 94143 | — |
| Elite Clinical Trials, Inc | Wildomar | California | 92595 | — |
| Avail Clinical Research, LLC | DeLand | Florida | 32720 | — |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | — |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32256 | — |
| 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 | — |
| Jersey Shore University Medical Center (JSUMC) | Neptune City | New Jersey | 07753 | — |
| Manhattan Behavioral Medicine | New York | New York | 10036 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| 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, Pearl Clinic | 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 NCT03260205, 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 Jun 8, 2021 · Synced Oct 17, 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 NCT03260205 live on ClinicalTrials.gov.