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Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2)

Primary Purpose

Attention Deficit Hyperactivity Disorder (ADHD)

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SPN-810
Placebo
Sponsored by
Supernus Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder (ADHD)

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Otherwise healthy male or female subjects, age 6 to 12 years at the time of screening with a primary diagnosis of ADHD and currently receiving monotherapy treatment with an optimized FDA-approved ADHD medication.
  • Impulsive aggression will be confirmed at screening using R-MOAS and Vitiello Aggression Scale.

Exclusion Criteria:

  • Current or lifetime diagnosis of epilepsy, major depressive disorder, bipolar disorder, schizophrenia or related disorder, personality disorder, Tourette's disorder, or psychosis not otherwise specified.
  • Currently meeting DSM criteria for autism spectrum disorder, pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder, or any other anxiety disorder as primary diagnosis.
  • Known or suspected intelligence quotient (IQ) < 70, suicidality, pregnancy, or substance or alcohol abuse.

Sites / Locations

  • Metropolitan Neuro Behavioral Institute
  • Woodland International Research Group
  • Sun Valley Research Center
  • Alliance for Wellness dba Alliance for Research
  • ASCLEPES Research Center
  • MCB Clinical Research Centers, LLC
  • Children's National Medical Center/Children's Research Institute
  • Gulfcoast Clinical Research Center
  • Indago Research & Health Center, Inc.
  • Innovative Clinical Research, Inc
  • Laszlo J. Mate, M.D., P.A.
  • APG Research, LLC
  • Miami Research Associates
  • University of South Florida- Dept. of Psychiatry and Neurosciences
  • Atlanta Center for Medical Research
  • iResearch Atlanta
  • Advanced Clinical Research
  • AMR Conventions Research
  • Pedia Research
  • Pedia Research
  • Louisiana State University Health Sciences Center
  • St. Charles Psychiatric Associates Midwest Research Center
  • Alivation Research, LLC
  • Quality Clinical Research
  • Hassmann Research Institute
  • Icahn School of Medicine at Mount Sinai
  • University of Cincinnati Department of Psychiatry and Behavioral Neuroscience
  • BioBehavioral Research of Austin P.C.
  • InSite Clinical Research
  • Houston Clinical Trials
  • Ericksen Research & Development
  • Pacific Institute of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Low dose SPN-810

High dose SPN-810

Placebo

Arm Description

Subjects will be treated with low dose of SPN-810

Subjects will be treated with high dose of SPN-810

Subjects will be treated with a Placebo

Outcomes

Primary Outcome Measures

Frequency of impulsive aggression behaviors per 7 days over a period of 7 weeks.
The frequency of impulsive aggression behaviors will be assessed using an impulsive aggression diary, a newly developed and validated electronic observer reported outcome measurement tool.

Secondary Outcome Measures

Full Information

First Posted
November 20, 2015
Last Updated
November 27, 2019
Sponsor
Supernus Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02618434
Brief Title
Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
November 2019 (Actual)
Study Completion Date
November 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Supernus Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to demonstrate the efficacy, safety and tolerability of SPN-810 in the treatment of impulsive aggression in patients with Attention Deficit/Hyperactivity Disorder (ADHD) in conjunction with standard ADHD treatment. Approximately 291 subjects aged 6 to 12 years with ADHD and comorbid impulsive aggression will be recruited in this study. The frequency of impulsive aggression behaviors will be assessed as a primary outcome. Additionally, the severity and improvement in impulsive aggression, and quality of life measures for the subject and caregiver will be assessed using validated scales.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder (ADHD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
297 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose SPN-810
Arm Type
Experimental
Arm Description
Subjects will be treated with low dose of SPN-810
Arm Title
High dose SPN-810
Arm Type
Experimental
Arm Description
Subjects will be treated with high dose of SPN-810
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will be treated with a Placebo
Intervention Type
Drug
Intervention Name(s)
SPN-810
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Frequency of impulsive aggression behaviors per 7 days over a period of 7 weeks.
Description
The frequency of impulsive aggression behaviors will be assessed using an impulsive aggression diary, a newly developed and validated electronic observer reported outcome measurement tool.
Time Frame
7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Otherwise healthy male or female subjects, age 6 to 12 years at the time of screening with a primary diagnosis of ADHD and currently receiving monotherapy treatment with an optimized FDA-approved ADHD medication. Impulsive aggression will be confirmed at screening using R-MOAS and Vitiello Aggression Scale. Exclusion Criteria: Current or lifetime diagnosis of epilepsy, major depressive disorder, bipolar disorder, schizophrenia or related disorder, personality disorder, Tourette's disorder, or psychosis not otherwise specified. Currently meeting DSM criteria for autism spectrum disorder, pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder, or any other anxiety disorder as primary diagnosis. Known or suspected intelligence quotient (IQ) < 70, suicidality, pregnancy, or substance or alcohol abuse.
Facility Information:
Facility Name
Metropolitan Neuro Behavioral Institute
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85226
Country
United States
Facility Name
Woodland International Research Group
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Sun Valley Research Center
City
Imperial
State/Province
California
ZIP/Postal Code
92251
Country
United States
Facility Name
Alliance for Wellness dba Alliance for Research
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Facility Name
ASCLEPES Research Center
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
MCB Clinical Research Centers, LLC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
Facility Name
Children's National Medical Center/Children's Research Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20310
Country
United States
Facility Name
Gulfcoast Clinical Research Center
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Indago Research & Health Center, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Innovative Clinical Research, Inc
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Laszlo J. Mate, M.D., P.A.
City
North Palm Beach
State/Province
Florida
ZIP/Postal Code
71103
Country
United States
Facility Name
APG Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Miami Research Associates
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
University of South Florida- Dept. of Psychiatry and Neurosciences
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
iResearch Atlanta
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Advanced Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
AMR Conventions Research
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Facility Name
Pedia Research
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47715
Country
United States
Facility Name
Pedia Research
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Facility Name
Louisiana State University Health Sciences Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
St. Charles Psychiatric Associates Midwest Research Center
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Facility Name
Alivation Research, LLC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
Quality Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Hassmann Research Institute
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of Cincinnati Department of Psychiatry and Behavioral Neuroscience
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
BioBehavioral Research of Austin P.C.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
InSite Clinical Research
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Houston Clinical Trials
City
Houston
State/Province
Texas
Country
United States
Facility Name
Ericksen Research & Development
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Facility Name
Pacific Institute of Medical Sciences
City
Bothell
State/Province
Washington
ZIP/Postal Code
98011
Country
United States

12. IPD Sharing Statement

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Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2)

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