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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01364662
Recruitment Status : Completed
First Posted : June 2, 2011
Last Update Posted : December 15, 2015
Information provided by (Responsible Party):
Supernus Pharmaceuticals, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Impulsive Aggression Comorbid With ADHD Drug: SPN-810 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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)
Study Start Date : June 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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.

Responsible Party: Supernus Pharmaceuticals, Inc. Identifier: NCT01364662     History of Changes
Other Study ID Numbers: 810P202
First Posted: June 2, 2011    Key Record Dates
Last Update Posted: December 15, 2015
Last Verified: November 2015

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

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Impulsive Behavior
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Behavioral Symptoms