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

NCT03597503 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: 810P503
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 38

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.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Effect of SPN-810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S)

  From Baseline/Visit 3 (Day 1) to Visit 4 (Day 15), Visit 5 (Day 22), Visit 6 (Day 29), Visit 7 (Day 36)

• Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score

  From Baseline/Visit 3 (Day 1) to Visit 4 (Day 15), Visit 5 (Day 22), Visit 6 (Day 29) and Visit 7 (Day 36).

• Effect of SPN-810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Remission Rate

  Visit 4 (Day 15), Visit 5 (Day 22), Visit 6 (Day 29) and Visit 7 (Day 36)

Study Arms (2)

Flexible dose of SPN-810

EXPERIMENTAL

Subjects treated with flexible dose of SPN-810

Drug: SPN-810

Placebo

PLACEBO COMPARATOR

Subjects treated with Placebo

Drug: Placebo

Interventions

SPN-810 DRUG

Flexible dose

Flexible dose of SPN-810

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Supernus Pharmaceuticals, Inc.: lead

Study Sites (38)

ProScience

Culver City, California, 90230, United States

Location

Neuropsychiatric Research Center of Orange County

Orange, California, 92868, United States

Location

MCB Clinical Research Centers, LLC

Colorado Springs, Colorado, 80910, United States

Location

Children's National Medical Center/Children's Research Institute

Washington D.C., District of Columbia, 20310, United States

Location

Clinical Neuroscience Solutions, Inc

Jacksonville, Florida, 32217, United States

Location

Meridien Research aka Florida Clinical Research Center, LLC

Lakeland, Florida, 33805, United States

Location

Florida Clinical Research Center, LLC.

Maitland, Florida, 32751, United States

Location

Miami Clinical Research

Miami, Florida, 33155, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

University of South Florida- Dept. of Psychiatry and Neurosciences

Tampa, Florida, 33613, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

iResearch Atlanta

Decatur, Georgia, 30030, United States

Location

Capstone Clinical Research

Libertyville, Illinois, 60048, United States

Location

AMR Conventions Research

Naperville, Illinois, 60563, United States

Location

Psychiatric Associates

Overland Park, Kansas, 66211, United States

Location

Hugo W Moser Research Institute at Kennedy Krieger

Baltimore, Maryland, 21205, United States

Location

St. Charles Psychiatric Associates Midwest Research Center

Saint Charles, Missouri, 63304, United States

Location

Alivation Research, LLC

Lincoln, Nebraska, 68526, United States

Location

Hassmann Research Institute

Berlin, New Jersey, 08009, United States

Location

Finger Lakes Clinical Research

Rochester, New York, 14618, United States

Location

University of Cincinnati Department of Psychiatry and Behavioral Neuroscience

Cincinnati, Ohio, 45219, United States

Location

Ohio State University Nisonger Center Clinical Trials Program

Columbus, Ohio, 43210, United States

Location

Oklahoma Clinical Research Center

Oklahoma City, Oklahoma, 73112, United States

Location

Paradigm Research Professionals

Oklahoma City, Oklahoma, 73118, United States

Location

CNS Healthcare

Memphis, Tennessee, 38119, United States

Location

Texas Physicians Medical Research Group

Arlington, Texas, 76014, United States

Location

BioBehavioral Research of Austin P.C.

Austin, Texas, 78759, United States

Location

Gaolin Research, LLC

Beaumont, Texas, 77702, United States

Location

Relaro Medical Trials

Dallas, Texas, 75243, United States

Location

InSite Clinical Research

DeSoto, Texas, 75115, United States

Location

Houston Clinical Trials

Houston, Texas, 08009, United States

Location

Dicovery MM Services Inc. Houston

Houston, Texas, 77061, United States

Location

FMCScience

Lampasas, Texas, 76550, United States

Location

Discovery MM Service, Inc. Missouri

Missouri City, Texas, 77459, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

Family Psychiatry of the Woodlands

The Woodlands, Texas, 77381, United States

Location

Ericksen Research & Development

Clinton, Utah, 84015, United States

Location

Aspen Clinical Research

Orem, Utah, 84058, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Gianpiera Ceresoli-Borroni/ Director Clinical Development
• Organization: Supernus

gceresoliborroni@supernus.com

3018382521

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, randomized, parallel group, two-arm, placebo-controlled study with flexible dosing

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: July 24, 2018
• Study Start: July 31, 2018
• Primary Completion: January 22, 2020
• Study Completion: January 22, 2020
• Last Updated: April 24, 2024
• Results First Posted: February 20, 2024

Record last verified: 2024-04

Locations

US (38)