A Study to Evaluate the Efficacy and Safety of SPN-810 as Adjunctive Therapy in Children With Impulsive Aggression Comorbid With Attention-Deficit/Hyperactivity Disorder (ADHD)
Public ClinicalTrials.gov record NCT01364662. 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 Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of SPN-810 as Adjunctive Therapy in Children With Impulsive Aggression Comorbid With Attention-Deficit/Hyperactivity Disorder (ADHD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This will be a randomized, double-blind, placebo-controlled, dose-ranging, efficacy and safety study in children with impulsive aggression comorbid with Attention-Deficit/Hyperactivity Disorder (ADHD). The target subjects are healthy male and female children aged 6 to 12 years, inclusive, with a diagnosis of ADHD. A total of 120 subjects will be randomized across approximately 30 US centers to one of four treatment groups.
Study identification
- NCT ID
- NCT01364662
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 121 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
- Jun 2011 (Type not available)
- Primary completion
- Oct 2012 (Actual)
- Completion
- Oct 2012 (Actual)
- Last update posted
- Feb 11, 2021
2011 – 2012
United States locations
- U.S. sites
- 27
- U.S. states
- 15
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Dothan | Alabama | — | — |
| Not listed | Los Angeles | California | — | — |
| Not listed | Santa Ana | California | — | — |
| Not listed | Washington D.C. | District of Columbia | — | — |
| Not listed | Bradenton | Florida | — | — |
| Not listed | Gainesville | Florida | — | — |
| Not listed | Hialeah | Florida | — | — |
| Not listed | Jacksonville | Florida | — | — |
| Not listed | Maitland | Florida | — | — |
| Not listed | North Miami | Florida | — | — |
| Not listed | Orlando | Florida | — | — |
| Not listed | Tampa | Florida | — | — |
| Not listed | Atlanta | Georgia | — | — |
| Not listed | Libertyville | Illinois | — | — |
| Not listed | Indianapolis | Indiana | — | — |
| Not listed | Terre Haute | Indiana | — | — |
| Not listed | Owensboro | Kentucky | — | — |
| Not listed | Toms River | New Jersey | — | — |
| Not listed | Stony Brook | New York | — | — |
| Not listed | Cleveland | Ohio | — | — |
| Not listed | Columbus | Ohio | — | — |
| Not listed | Philadelphia | Pennsylvania | — | — |
| Not listed | Pittsburgh | Pennsylvania | — | — |
| Not listed | Charleston | South Carolina | — | — |
| Not listed | Memphis | Tennessee | — | — |
| Not listed | Bellevue | Washington | — | — |
| Not listed | Bothell | Washington | — | — |
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 NCT01364662, 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 Feb 11, 2021 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01364662 live on ClinicalTrials.gov.