A Study to Evaluate the Efficacy and Safety of SPN-810 as Adjunctive Therapy in Children With Impulsive Aggression Comorbid With Attention-Deficit/Hyperactivity Disorder (ADHD)

February 9, 2021 updated by: Supernus Pharmaceuticals, Inc.

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of SPN-810 as Adjunctive Therapy in Children With Impulsive Aggression Comorbid With Attention-Deficit/Hyperactivity Disorder (ADHD)

This will be a randomized, double-blind, placebo-controlled, dose-ranging, efficacy and safety study in children with impulsive aggression comorbid with Attention-Deficit/Hyperactivity Disorder (ADHD). The target subjects are healthy male and female children aged 6 to 12 years, inclusive, with a diagnosis of ADHD. A total of 120 subjects will be randomized across approximately 30 US centers to one of four treatment groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Dothan, Alabama, United States
    • California
      • Los Angeles, California, United States
      • Santa Ana, California, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Bradenton, Florida, United States
      • Gainesville, Florida, United States
      • Hialeah, Florida, United States
      • Jacksonville, Florida, United States
      • Maitland, Florida, United States
      • North Miami, Florida, United States
      • Orlando, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Libertyville, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
      • Terre Haute, Indiana, United States
    • Kentucky
      • Owensboro, Kentucky, United States
    • New Jersey
      • Toms River, New Jersey, United States
    • New York
      • Stony Brook, New York, United States
    • Ohio
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • South Carolina
      • Charleston, South Carolina, United States
    • Tennessee
      • Memphis, Tennessee, United States
    • Washington
      • Bellevue, Washington, United States
      • Bothell, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy pediatric male or female subjects, age 6 to 12 years.
  2. Diagnostic and Statistical Manual of Mental Disorders - IV -Text Revision (DSM-IV-TR) diagnosis of ADHD.
  3. R-MOAS score >=24 at screening and R-MOAS score >=20 for randomization
  4. IQ greater than 71.
  5. Weight of >=20kg
  6. current treatment with psychostimulant (1 month prior to screening)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Placebo
administered orally
Experimental: 2
Drug: SPN-810
administered orally
Experimental: 3
Drug: SPN-810
administered orally
Experimental: 4
Drug: SPN-810
administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in aggressive behavior as assessed by R-MOAS score
Time Frame: Change from baseline to Visit 10
Change from baseline to Visit 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of SPN-810 Safety as assessed by safety scales, AEs, clinical labs, vitals, Physical Exams, and ECGs
Time Frame: Visit 2 to End of Study
Safety as assessed by safety scales, AEs, clinical labs, vitals, Physical Exams, and ECGs
Visit 2 to End of Study
Change in CGI-S
Time Frame: Baseline to Visit 5
Baseline to Visit 5
CGI-I score at each post-baseline Visit
Time Frame: Baseline to Visit 5
Baseline to Visit 5
Change in SNAP-IV ADHD scores
Time Frame: Baseline to Visit 5
Baseline to Visit 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Supernus Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

May 25, 2011

First Submitted That Met QC Criteria

June 1, 2011

First Posted (Estimate)

June 2, 2011

Study Record Updates

Last Update Posted (Actual)

February 11, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 810P202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Impulsive Aggression Comorbid With ADHD

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe