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

Attention Deficit Hyperactivity Disorder Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03597503
• Other study ID #: 810P503
• Status: Terminated
• Phase: Phase 3
• Start date: July 31, 2018
• Est. completion date: January 22, 2020

Study information

• Verified date: April 2024
• Source: Supernus Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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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Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: January 22, 2020
• Est. primary completion date: January 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aggression
• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• SPN-810
Flexible dose
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Texas Physicians Medical Research Group	Arlington	Texas
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	BioBehavioral Research of Austin P.C.	Austin	Texas
United States	Hugo W Moser Research Institute at Kennedy Krieger	Baltimore	Maryland
United States	Gaolin Research, LLC	Beaumont	Texas
United States	Hassmann Research Institute	Berlin	New Jersey
United States	University of Cincinnati Department of Psychiatry and Behavioral Neuroscience	Cincinnati	Ohio
United States	Ericksen Research & Development	Clinton	Utah
United States	MCB Clinical Research Centers, LLC	Colorado Springs	Colorado
United States	Ohio State University Nisonger Center Clinical Trials Program	Columbus	Ohio
United States	ProScience	Culver City	California
United States	Relaro Medical Trials	Dallas	Texas
United States	iResearch Atlanta	Decatur	Georgia
United States	InSite Clinical Research	DeSoto	Texas
United States	Dicovery MM Services Inc. Houston	Houston	Texas
United States	Houston Clinical Trials	Houston	Texas
United States	Clinical Neuroscience Solutions, Inc	Jacksonville	Florida
United States	Meridien Research aka Florida Clinical Research Center, LLC	Lakeland	Florida
United States	FMCScience	Lampasas	Texas
United States	Capstone Clinical Research	Libertyville	Illinois
United States	Alivation Research, LLC	Lincoln	Nebraska
United States	Florida Clinical Research Center, LLC.	Maitland	Florida
United States	CNS Healthcare	Memphis	Tennessee
United States	Miami Clinical Research	Miami	Florida
United States	Discovery MM Service, Inc. Missouri	Missouri City	Texas
United States	AMR Conventions Research	Naperville	Illinois
United States	Oklahoma Clinical Research Center	Oklahoma City	Oklahoma
United States	Paradigm Research Professionals	Oklahoma City	Oklahoma
United States	Neuropsychiatric Research Center of Orange County	Orange	California
United States	Aspen Clinical Research	Orem	Utah
United States	Psychiatric Associates	Overland Park	Kansas
United States	Finger Lakes Clinical Research	Rochester	New York
United States	St. Charles Psychiatric Associates Midwest Research Center	Saint Charles	Missouri
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	Miami Research Associates	South Miami	Florida
United States	University of South Florida- Dept. of Psychiatry and Neurosciences	Tampa	Florida
United States	Family Psychiatry of the Woodlands	The Woodlands	Texas
United States	Children's National Medical Center/Children's Research Institute	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Supernus Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of SPN-810 Treatment on the Frequency of Impulsive Aggression (IA) Behaviors Measured by the Impulsive Aggression Diary	The primary efficacy endpoint was percent change (PCHT) in the frequency (unweighted score) of IA behaviors per 7 days in the treatment (titration and maintenance) period relative to the baseline period calculated over the number of days with non-missing IA diary data. PCHT was then calculated as 100 x (T - B)/B, where T and B are IA behavior frequencies per 7 days during the treatment period (from Day 2 through Visit 7, inclusive) and baseline period (Day =1), respectively. The IA behavior frequency per 7 days is defined as (SUM/DAY) x 7, where SUM is the total of the IA behaviors reported in the subject IA diary, and DAY is the number of days with a non-missing IA score in the subject IA diary during the specified study period.	Daily measure from Visit 2 (Day -15) to Visit 7 (Day 36) for a total of 7 weeks
Secondary	Effect of SPN-810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S)	The Clinical Global Impression - Severity of Illness (CGI-S) is a single item clinician rating of clinician's assessment of the severity of IA behaviors. CGI-S was evaluated by the Investigator at each visit on a 7- point scale with 1=Normal, 2=Borderline ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Extremely ill.; Data represent the change between Baseline (Visit 3/Day 1) and four time points: Visit 4 (Day 15); Visit 5 (Day 22), Visit 6 (Day 29) and Visit 7 (Day 36).	From Baseline/Visit 3 (Day 1) to Visit 4 (Day 15), Visit 5 (Day 22), Visit 6 (Day 29), Visit 7 (Day 36)
Secondary	Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score	R-MOAS scale gauges the severity of aggressive behavior: the frequency of the 16 behaviors is rated over the past week in 4 areas (VE, PH, PR, SE). For each open question in each area, the parent-rated the aggressive behaviors on a scale from 0 to 5 or more times. To each area corresponds a weighted category: Verbal Incidents (VE)=1, Incidents Toward Other (PH)=4, Incidents Involving Property (PR)=2 and Incidents Directed Toward Self (SE)=3. Therefore, the sum of each area yields a maximum weighted score of 20 (VE), 120 (PH), 60 (PR), and 90 (SE). The total score is the sum of the four area scores or 0-290; the higher the score, the more severe the aggressive behavior is.; Data represent the total score change between the Baseline (Visit 3/Day 1) and four time points: Visit 4 (Day 15); Visit 5 (Day 22), Visit 6 (Day 29), and Visit 7 (Day 36).	From Baseline/Visit 3 (Day 1) to Visit 4 (Day 15), Visit 5 (Day 22), Visit 6 (Day 29) and Visit 7 (Day 36).
Secondary	Effect of SPN-810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Remission Rate	The treatment effect on the R-MOAS was assessed to capture the severity of the aggressive behaviors. The remission rate was defined as percentage of subjects with a R-MOAS total score = 10.; Data represent the percentage of subjects at four time points during the treatment period: Visit 4 (Day 15); Visit 5 (Day 22), Visit 6 (Day 29) and Visit 7 (Day 36).	Visit 4 (Day 15), Visit 5 (Day 22), Visit 6 (Day 29) and Visit 7 (Day 36)