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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02618434
Recruitment Status : Completed
First Posted : December 1, 2015
Last Update Posted : November 29, 2019
Sponsor:
Information provided by (Responsible Party):
Supernus Pharmaceuticals, Inc.

Study Description
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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 291 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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder (ADHD) Drug: SPN-810 Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 297 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : March 2015
Actual Primary Completion Date : November 2019
Actual Study Completion Date : November 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Low dose SPN-810
Subjects will be treated with low dose of SPN-810
 Drug: SPN-810
Experimental: High dose SPN-810
Subjects will be treated with high dose of SPN-810
 Drug: SPN-810
Placebo Comparator: Placebo
Subjects will be treated with a Placebo
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of impulsive aggression behaviors per 7 days over a period of 7 weeks. [ Time Frame: 7 weeks ]
    The frequency of impulsive aggression behaviors will be assessed using an impulsive aggression diary, a newly developed and validated electronic observer reported outcome measurement tool.


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Current or lifetime diagnosis of epilepsy, major depressive disorder, bipolar disorder, schizophrenia or 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 primary diagnosis.
  • Known or suspected intelligence quotient (IQ) < 70, suicidality, pregnancy, or substance or alcohol abuse.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02618434


Locations
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Sponsors and Collaborators
Supernus Pharmaceuticals, Inc.
More Information
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Responsible Party: Supernus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02618434    
Other Study ID Numbers: 810P302
First Posted: December 1, 2015    Key Record Dates
Last Update Posted: November 29, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders