Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2)

NCT02618434 | Completed Phase 3 Results

• 1 other identifier: 810P302
• Study Type: interventional
• Target: 297
• Locations: 1 country
• Sites: 32

Brief Summary

The purpose of this study is to demonstrate the efficacy, safety, and tolerability of SPN-810 in the treatment of impulsive aggression in patients with Attention-Deficit/Hyperactivity Disorder (ADHD) in conjunction with standard ADHD treatment. Approximately 297 subjects aged 6 to 12 years with ADHD and comorbid impulsive aggression will be recruited in this study. The frequency of impulsive aggression behaviors will be assessed as a primary outcome. Additionally, the severity and improvement in impulsive aggression and quality of life measures for the subject and caregiver will be assessed using validated scales.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Outcome Measures

Primary Outcomes (1)

• Efficacy and Safety of SPN-810 on the Frequency of Impulsive Aggression (IA) 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 6, 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 (Week -2) to Visit 6 (Week 5) for a total of 7 weeks

Secondary Outcomes (7)

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

  Baseline/Visit 3 (Day 1), Visit 4 (Week 1), Visit 5 (Week 2), and Visit 6 (Week 5). The total duration of the study was 5 weeks.

• Effect of SPN-810 on Impulsive Aggression Measured by Clinical Global Impression-Improvement (CGI-I) Scale Investigator Rated

  Visit 4 (Week 1), Visit 5 (Week 2) and Visit 6 (Week 5), a total of 4 weeks

• Effect of SPN-810 on Impulsive Aggression Measured by Child Health Questionnaire Parent Form 28-item (CHQ-PF28)

  Baseline Visit 3 (Day 1) and Visit 6 (Week 5). Total duration of the study was 5 weeks.

• Effect of SPN-810 on Impulsive Aggression Measured by Parenting Stress Index, Fourth Edition, Short Form (PSI-4-SF)

  Baseline Visit 3 (Day 1) and Visit 6 (Week 5). Total duration of the study was 5 weeks.

• Effect of SPN-810 on Impulsive Aggression Measured by Clinical Global Impression-Improvement (CGI-I) Scale Caregiver Rated

  Visit 4 (Week 1), Visit 5 (Week 2) and Visit 6 (Week 5), a total of 4 weeks

Study Arms (3)

Low dose SPN-810 (18 mg)

EXPERIMENTAL

Oral

Drug: SPN-810 (18 mg)

High dose SPN-810 (36 mg)

EXPERIMENTAL

Oral

Drug: SPN-810 (36 mg)

Placebo

PLACEBO COMPARATOR

Oral

Drug: Placebo

Interventions

SPN-810 (18 mg) DRUG

Subjects were randomized to receive SPN-810 9 mg twice each day with food, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.

Low dose SPN-810 (18 mg)

SPN-810 (36 mg) DRUG

Subjects were randomized to receive SPN-810 18 mg twice each day with food, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.

High dose SPN-810 (36 mg)

Placebo DRUG

Subjects were randomized to receive Placebo twice each day with food, in the morning and in the evening, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.

Placebo

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Otherwise healthy male or female subjects, age 6 to 12 years at the time of screening with a primary diagnosis of ADHD and currently receiving monotherapy treatment with an optimized FDA-approved ADHD medication.
• Impulsive aggression will be confirmed at screening using R-MOAS and Vitiello Aggression Scale.

You may not qualify if:

• Current or lifetime diagnosis of epilepsy, major depressive disorder, bipolar disorder, schizophrenia or a related disorder, personality disorder, Tourette's disorder, or psychosis not otherwise specified.
• Currently meeting DSM criteria for autism spectrum disorder, pervasive developmental disorder, obsessive-compulsive disorder, post-traumatic stress disorder, or any other anxiety disorder as the primary diagnosis.
• Known or suspected intelligence quotient (IQ) \< 70, suicidality, pregnancy, or substance or alcohol abuse.

Sponsors & Collaborators

• Supernus Pharmaceuticals, Inc.: lead

Study Sites (32)

Metropolitan Neuro Behavioral Institute

Chandler, Arizona, 85226, United States

Location

Woodland International Research Group

Little Rock, Arkansas, 72211, United States

Location

Sun Valley Research Center

Imperial, California, 92251, United States

Location

Alliance for Wellness dba Alliance for Research

Long Beach, California, 90807, United States

Location

ASCLEPES Research Center

Panorama City, California, 91402, 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

Gulfcoast Clinical Research Center

Fort Myers, Florida, 33912, United States

Location

Indago Research & Health Center, Inc.

Hialeah, Florida, 33012, United States

Location

Innovative Clinical Research, Inc

Lauderhill, Florida, 33319, United States

Location

Laszlo J. Mate, M.D., P.A.

North Palm Beach, Florida, 71103, United States

Location

APG Research, LLC

Orlando, Florida, 32803, 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

Advanced Clinical Research

Meridian, Idaho, 83642, United States

Location

AMR Conventions Research

Naperville, Illinois, 60563, United States

Location

Pedia Research

Evansville, Indiana, 47715, United States

Location

Pedia Research

Owensboro, Kentucky, 42301, United States

Location

Louisiana State University Health Sciences Center

Shreveport, Louisiana, 71103, 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

Quality Clinical Research

Omaha, Nebraska, 68114, United States

Location

Hassmann Research Institute

Berlin, New Jersey, 08009, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

University of Cincinnati Department of Psychiatry and Behavioral Neuroscience

Cincinnati, Ohio, 45219, United States

Location

BioBehavioral Research of Austin P.C.

Austin, Texas, 78759, United States

Location

InSite Clinical Research

DeSoto, Texas, 75115, United States

Location

Houston Clinical Trials

Houston, Texas, United States

Location

Ericksen Research & Development

Clinton, Utah, 84015, United States

Location

Pacific Institute of Medical Sciences

Bothell, Washington, 98011, 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 Research
• Organization: Supernus Pharmaceuticals

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2015
• First Posted: December 1, 2015
• Study Start: February 16, 2016
• Primary Completion: November 15, 2019
• Study Completion: February 14, 2020
• Last Updated: March 18, 2024
• Results First Posted: March 18, 2024

Record last verified: 2024-03

Locations

US (32)