Clinical trial NCT03597503: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Supernus Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2018-07-24
Enrollment: 41
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, randomized, parallel group, two-arm, placebo-controlled study with flexible dosing
Primary purpose: TREATMENT

Brief summary: The purpose of this study was 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 was an addition to the 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 was administered in patients diagnosed with ADHD and associated features of IA, who were currently treated with an FDA-approved standard ADHD treatment and displayed persistent IA behaviors. The frequency of impulsive aggressive behaviors was assessed as a primary outcome.

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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 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.

Primary outcomes:
measure: Effect of SPN-810 Treatment on the Frequency of Impulsive Aggression (IA) Behaviors Measured by the Impulsive Aggression Diary
timeFrame: Daily measure from Visit 2 (Day -15) to Visit 7 (Day 36) for a total of 7 weeks
Secondary outcomes:
measure: Effect of SPN-810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S)
timeFrame: From Baseline/Visit 3 (Day 1) to Visit 4 (Day 15), Visit 5 (Day 22), Visit 6 (Day 29), Visit 7 (Day 36)
measure: Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score
timeFrame: From Baseline/Visit 3 (Day 1) to Visit 4 (Day 15), Visit 5 (Day 22), Visit 6 (Day 29) and Visit 7 (Day 36).
measure: Effect of SPN-810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Remission Rate
timeFrame: Visit 4 (Day 15), Visit 5 (Day 22), Visit 6 (Day 29) and Visit 7 (Day 36)
Other outcomes:
Locations:
city: Culver City
country: United States
facility: ProScience
state: California
city: Orange
country: United States
facility: Neuropsychiatric Research Center of Orange County
state: California
city: Colorado Springs
country: United States
facility: MCB Clinical Research Centers, LLC
state: Colorado
city: Washington
country: United States
facility: Children's National Medical Center/Children's Research Institute
state: District of Columbia
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Florida
city: Lakeland
country: United States
facility: Meridien Research aka Florida Clinical Research Center, LLC
state: Florida
city: Maitland
country: United States
facility: Florida Clinical Research Center, LLC.
state: Florida
city: Miami
country: United States
facility: Miami Clinical Research
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Tampa
country: United States
facility: University of South Florida- Dept. of Psychiatry and Neurosciences
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta
state: Georgia
city: Libertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Naperville
country: United States
facility: AMR Conventions Research
state: Illinois
city: Overland Park
country: United States
facility: Psychiatric Associates
state: Kansas
city: Baltimore
country: United States
facility: Hugo W Moser Research Institute at Kennedy Krieger
state: Maryland
city: Saint Charles
country: United States
facility: St. Charles Psychiatric Associates Midwest Research Center
state: Missouri
city: Lincoln
country: United States
facility: Alivation Research, LLC
state: Nebraska
city: Berlin
country: United States
facility: Hassmann Research Institute
state: New Jersey
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Department of Psychiatry and Behavioral Neuroscience
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Nisonger Center Clinical Trials Program
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Clinical Research Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Paradigm Research Professionals
state: Oklahoma
city: Memphis
country: United States
facility: CNS Healthcare
state: Tennessee
city: Arlington
country: United States
facility: Texas Physicians Medical Research Group
state: Texas
city: Austin
country: United States
facility: BioBehavioral Research of Austin P.C.
state: Texas
city: Beaumont
country: United States
facility: Gaolin Research, LLC
state: Texas
city: Dallas
country: United States
facility: Relaro Medical Trials
state: Texas
city: DeSoto
country: United States
facility: InSite Clinical Research
state: Texas
city: Houston
country: United States
facility: Houston Clinical Trials
state: Texas
city: Houston
country: United States
facility: Dicovery MM Services Inc. Houston
state: Texas
city: Lampasas
country: United States
facility: FMCScience
state: Texas
city: Missouri City
country: United States
facility: Discovery MM Service, Inc. Missouri
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: The Woodlands
country: United States
facility: Family Psychiatry of the Woodlands
state: Texas
city: Clinton
country: United States
facility: Ericksen Research & Development
state: Utah
city: Orem
country: United States
facility: Aspen Clinical Research
state: Utah
Study officials:
References: