search
Back to results

Treatment of Impulsive Aggression (IA) in Adolescent With ADHD in Conjunction With Standard ADHD Treatment

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Terminated
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

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Otherwise, healthy non-smoking, male and females adolescents (12-17 years of age at the time of screening) with a primary diagnosis of ADHD and currently taking an optimized FDA-approved ADHD medication.
  • IA will be confirmed at screening using R-MOAS scale and Vitiello Aggression Questionnaire.

Exclusion Criteria:

  • History or current diagnosis of epilepsy, major depressive disorder, bipolar disorder, schizophrenia and other psychotic disorders, personality disorder, Tourette's syndrome or dissociative disorder, autism spectrum disorder, pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder, or intermittent explosive disorder.
  • Currently meeting DSM-5 criteria for pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder or intermittent explosive disorder.
  • Known or suspected intelligence quotient (IQ) <70, active suicidal plan/intent or active suicidal thought, criminal arrest, alcohol or drug use or pregnancy.

Sites / Locations

  • ProScience
  • Neuropsychiatric Research Center of Orange County
  • MCB Clinical Research Centers, LLC
  • Children's National Medical Center/Children's Research Institute
  • Clinical Neuroscience Solutions, Inc
  • Meridien Research aka Florida Clinical Research Center, LLC
  • Florida Clinical Research Center, LLC.
  • Miami Clinical Research
  • Miami Research Associates
  • University of South Florida- Dept. of Psychiatry and Neurosciences
  • Atlanta Center for Medical Research
  • iResearch Atlanta
  • Capstone Clinical Research
  • AMR Conventions Research
  • Psychiatric Associates
  • Hugo W Moser Research Institute at Kennedy Krieger
  • St. Charles Psychiatric Associates Midwest Research Center
  • Alivation Research, LLC
  • Hassmann Research Institute
  • Finger Lakes Clinical Research
  • University of Cincinnati Department of Psychiatry and Behavioral Neuroscience
  • Ohio State University Nisonger Center Clinical Trials Program
  • Oklahoma Clinical Research Center
  • Paradigm Research Professionals
  • CNS Healthcare
  • Texas Physicians Medical Research Group
  • BioBehavioral Research of Austin P.C.
  • Gaolin Research, LLC
  • Relaro Medical Trials
  • InSite Clinical Research
  • Houston Clinical Trials
  • Dicovery MM Services Inc. Houston
  • FMCScience
  • Discovery MM Service, Inc. Missouri
  • Clinical Trials of Texas, Inc.
  • Family Psychiatry of the Woodlands
  • Ericksen Research & Development
  • Aspen Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Flexible dose of SPN-810

Placebo

Arm Description

Subjects will be treated with flexible dose of SPN-810

Subjects will be treated with 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 measured using an impulsive aggression (IA) diary, developed by the sponsor as an electronic observer-reported outcome (eObsRO) instrument.

Secondary Outcome Measures

Full Information

First Posted
July 12, 2018
Last Updated
October 19, 2020
Sponsor
Supernus Pharmaceuticals, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03597503
Brief Title
Treatment of Impulsive Aggression (IA) in Adolescent With ADHD in Conjunction With Standard ADHD Treatment
Official Title
Assessment of Efficacy and Safety of SPN-810 for the Treatment of Impulsive Aggression (IA) in Adolescent Subjects With Attention Deficit/Hyperactivity Disorder (ADHD) in Conjunction With Standard ADHD Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
Financial decision
Study Start Date
July 31, 2018 (Actual)
Primary Completion Date
January 22, 2020 (Actual)
Study Completion Date
January 22, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effect of SPN-810 for the treatment of impulsive aggression (IA) in adolescents diagnosed with ADHD when taken in conjunction with standard ADHD treatment.
Detailed Description
This study is an addition to the ongoing pediatric studies (CHIME 1 and CHIME 2) to assess the efficacy and safety of SPN-810 in the improvement of impulsive aggression (IA) behaviors in adolescents with ADHD. SPN-810 will be administered in patients diagnosed with ADHD and associated feature of IA, who are currently being treated with an FDA-approved standard ADHD treatment and with persistent IA behaviors. The frequency of impulsive aggressive behaviors will be assessed as a primary outcome. .

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Double-blind, randomized, parallel group, two-arm, placebo-controlled study with flexible dosing
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
186 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Flexible dose of SPN-810
Arm Type
Experimental
Arm Description
Subjects will be treated with flexible dose of SPN-810
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will be treated with Placebo
Intervention Type
Drug
Intervention Name(s)
SPN-810
Intervention Description
Flexible dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 measured using an impulsive aggression (IA) diary, developed by the sponsor as an electronic observer-reported outcome (eObsRO) instrument.
Time Frame
7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Otherwise, healthy non-smoking, male and females adolescents (12-17 years of age at the time of screening) with a primary diagnosis of ADHD and currently taking an optimized FDA-approved ADHD medication. IA will be confirmed at screening using R-MOAS scale and Vitiello Aggression Questionnaire. Exclusion Criteria: History or current diagnosis of epilepsy, major depressive disorder, bipolar disorder, schizophrenia and other psychotic disorders, personality disorder, Tourette's syndrome or dissociative disorder, autism spectrum disorder, pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder, or intermittent explosive disorder. Currently meeting DSM-5 criteria for pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder or intermittent explosive disorder. Known or suspected intelligence quotient (IQ) <70, active suicidal plan/intent or active suicidal thought, criminal arrest, alcohol or drug use or pregnancy.
Facility Information:
Facility Name
ProScience
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Facility Name
Neuropsychiatric Research Center of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
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
Clinical Neuroscience Solutions, Inc
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32217
Country
United States
Facility Name
Meridien Research aka Florida Clinical Research Center, LLC
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Florida Clinical Research Center, LLC.
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Miami Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
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
Capstone Clinical Research
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
AMR Conventions Research
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Facility Name
Psychiatric Associates
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Hugo W Moser Research Institute at Kennedy Krieger
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
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
Hassmann Research Institute
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Finger Lakes Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
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
Ohio State University Nisonger Center Clinical Trials Program
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oklahoma Clinical Research Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Paradigm Research Professionals
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Facility Name
CNS Healthcare
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Texas Physicians Medical Research Group
City
Arlington
State/Province
Texas
ZIP/Postal Code
76014
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
Gaolin Research, LLC
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
Relaro Medical Trials
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
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
ZIP/Postal Code
08009
Country
United States
Facility Name
Dicovery MM Services Inc. Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77061
Country
United States
Facility Name
FMCScience
City
Lampasas
State/Province
Texas
ZIP/Postal Code
76550
Country
United States
Facility Name
Discovery MM Service, Inc. Missouri
City
Missouri City
State/Province
Texas
ZIP/Postal Code
77459
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Family Psychiatry of the Woodlands
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77381
Country
United States
Facility Name
Ericksen Research & Development
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Facility Name
Aspen Clinical Research
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Treatment of Impulsive Aggression (IA) in Adolescent With ADHD in Conjunction With Standard ADHD Treatment

We'll reach out to this number within 24 hrs