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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)

This study has been completed.
Information provided by (Responsible Party):
Supernus Pharmaceuticals, Inc. Identifier:
First received: May 25, 2011
Last updated: November 16, 2015
Last verified: November 2015
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.

Condition Intervention Phase
Impulsive Aggression Comorbid With ADHD
Drug: SPN-810
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Supernus Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Reduction in aggressive behavior as assessed by R-MOAS score [ Time Frame: after approximately 6 weeks ]

Secondary Outcome Measures:
  • Safety [ Time Frame: after approximately 6 weeks ]
    Safety as assessed by safety scales, AEs, clinical labs, vitals, PEs, ECGs, etc

Enrollment: 121
Study Start Date: June 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Placebo
administered orally
Experimental: 2 Drug: SPN-810
administered orally
Experimental: 3 Drug: SPN-810
administered orally
Experimental: 4 Drug: SPN-810
administered orally


Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Healthy pediatric male or female subjects, age 6 to 12 years.
  2. Diagnostic and Statistical Manual of Mental Disorders - IV -Text Revision (DSM-IV-TR) diagnosis of ADHD.
  3. R-MOAS score >=24 at screening and R-MOAS score >=20 for randomization
  4. IQ greater than 71.
  5. Weight of >=20kg
  6. current treatment with psychostimulant (1 month prior to screening)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01364662

  Hide Study Locations
United States, Alabama
Dothan, Alabama, United States
United States, California
Los Angeles, California, United States
Santa Ana, California, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
Bradenton, Florida, United States
Gainesville, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Maitland, Florida, United States
North Miami, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Illinois
Libertyville, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
Terre Haute, Indiana, United States
United States, Kentucky
Owensboro, Kentucky, United States
United States, New Jersey
Toms River, New Jersey, United States
United States, New York
Stony Brook, New York, United States
United States, Ohio
Cleveland, Ohio, United States
Columbus, Ohio, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
United States, Tennessee
Memphis, Tennessee, United States
United States, Washington
Bellevue, Washington, United States
Bothell, Washington, United States
Sponsors and Collaborators
Supernus Pharmaceuticals, Inc.
  More Information

Responsible Party: Supernus Pharmaceuticals, Inc. Identifier: NCT01364662     History of Changes
Other Study ID Numbers: 810P202
Study First Received: May 25, 2011
Last Updated: November 16, 2015

Keywords provided by Supernus Pharmaceuticals, Inc.:
Impulsive Aggression
Attention Deficit Hyperactivity Disorder

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Behavioral Symptoms processed this record on April 28, 2017