Back to resultsA 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)
Primary Purpose
Impulsive Aggression Comorbid With ADHD
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SPN-810
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Impulsive Aggression Comorbid With ADHD focused on measuring Impulsive Aggression, Attention Deficit Hyperactivity Disorder, ADHD
Eligibility Criteria
Inclusion Criteria:
- 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
Arm Description
Outcomes
Primary Outcome Measures
Reduction in aggressive behavior as assessed by R-MOAS score
Secondary Outcome Measures
Safety of SPN-810 Safety as assessed by safety scales, AEs, clinical labs, vitals, Physical Exams, and ECGs
Safety as assessed by safety scales, AEs, clinical labs, vitals, Physical Exams, and ECGs
Change in CGI-S
CGI-I score at each post-baseline Visit
Change in SNAP-IV ADHD scores
Full Information
NCT ID
NCT01364662
First Posted
May 25, 2011
Last Updated
February 9, 2021
Sponsor
Supernus Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01364662
Brief Title
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)
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 Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impulsive Aggression Comorbid With ADHD
Keywords
Impulsive Aggression, Attention Deficit Hyperactivity Disorder, ADHD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SPN-810
Intervention Description
administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
administered orally
Primary Outcome Measure Information:
Title
Reduction in aggressive behavior as assessed by R-MOAS score
Time Frame
Change from baseline to Visit 10
Secondary Outcome Measure Information:
Title
Safety of SPN-810 Safety as assessed by safety scales, AEs, clinical labs, vitals, Physical Exams, and ECGs
Description
Safety as assessed by safety scales, AEs, clinical labs, vitals, Physical Exams, and ECGs
Time Frame
Visit 2 to End of Study
Title
Change in CGI-S
Time Frame
Baseline to Visit 5
Title
CGI-I score at each post-baseline Visit
Time Frame
Baseline to Visit 5
Title
Change in SNAP-IV ADHD scores
Time Frame
Baseline to Visit 5
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:
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)
Facility Information:
City
Dothan
State/Province
Alabama
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Santa Ana
State/Province
California
Country
United States
City
Washington
State/Province
District of Columbia
Country
United States
City
Bradenton
State/Province
Florida
Country
United States
City
Gainesville
State/Province
Florida
Country
United States
City
Hialeah
State/Province
Florida
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Maitland
State/Province
Florida
Country
United States
City
North Miami
State/Province
Florida
Country
United States
City
Orlando
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Libertyville
State/Province
Illinois
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Terre Haute
State/Province
Indiana
Country
United States
City
Owensboro
State/Province
Kentucky
Country
United States
City
Toms River
State/Province
New Jersey
Country
United States
City
Stony Brook
State/Province
New York
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Memphis
State/Province
Tennessee
Country
United States
City
Bellevue
State/Province
Washington
Country
United States
City
Bothell
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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)
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