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)

Completed · Phase 2 · Has a placebo group

Conditions studied: Impulsive Aggression Comorbid With ADHD

In brief

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.

Key facts

Study ID

NCT01364662

Run by

Supernus Pharmaceuticals, Inc.

People needed

121

Starts

2011-06-01

Expected to finish

2012-10-01

Last updated by the study team

2021-02-11

Who can join

Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Healthy pediatric male or female subjects, age 6 to 12 years.
• Diagnostic and Statistical Manual of Mental Disorders - IV -Text Revision (DSM-IV-TR) diagnosis of ADHD.
• R-MOAS score >=24 at screening and R-MOAS score >=20 for randomization
• IQ greater than 71.
• Weight of >=20kg
• current treatment with psychostimulant (1 month prior to screening)

Where it is running

• Study site — Dothan, Alabama, United States
• Study site — Los Angeles, California, United States
• Study site — Santa Ana, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Bradenton, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Maitland, Florida, United States
• Study site — North Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Libertyville, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Terre Haute, Indiana, United States
• Study site — Owensboro, Kentucky, United States
• Study site — Toms River, New Jersey, United States
• Study site — Stony Brook, New York, United States
• Study site — Cleveland, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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