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

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ClinicalTrials.gov Identifier: NCT03597503
Recruitment Status : Recruiting
First Posted : July 24, 2018
Last Update Posted : November 25, 2019
Sponsor:
Information provided by (Responsible Party):
Supernus Pharmaceuticals, Inc.

Brief Summary:
The purpose of this study is 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.

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

Detailed Description:

This study is an addition to the ongoing 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 will be administered in patients diagnosed with ADHD and associated feature of IA, who are currently being treated with an FDA-approved standard ADHD treatment and with persistent IA behaviors. The frequency of impulsive aggressive behaviors will be assessed as a primary outcome.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind, randomized, parallel group, two-arm, placebo-controlled study with flexible dosing
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: 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
Actual Study Start Date : July 31, 2018
Estimated Primary Completion Date : July 29, 2020
Estimated Study Completion Date : December 20, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Flexible dose of SPN-810
Subjects will be treated with flexible dose of SPN-810
Drug: SPN-810
Flexible dose

Placebo Comparator: Placebo
Subjects will be treated with Placebo
Drug: Placebo
Placebo




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 measured using an impulsive aggression (IA) diary, developed by the sponsor as an electronic observer-reported outcome (eObsRO) instrument.



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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 will be 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.

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): NCT03597503


Contacts
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Contact: Ronald Marcus, MD 301-838-2569 rmarcus@supernus.com

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Sponsors and Collaborators
Supernus Pharmaceuticals, Inc.

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Responsible Party: Supernus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03597503     History of Changes
Other Study ID Numbers: 810P503
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: November 25, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Aggression
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Behavioral Symptoms