Skip to main content
OpenTrials
Completed

NCT Number: NCT01364662

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)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Impulsive Aggression Comorbid With ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dothan, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

SPN-810

Drug

administered orally

Placebo

Drug

administered orally

Primary outcomes

  1. Reduction in aggressive behavior as assessed by R-MOAS score

    Time frame: Change from baseline to Visit 10

Secondary outcomes

  1. 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

  2. Change in CGI-S

    Time frame: Baseline to Visit 5

  3. CGI-I score at each post-baseline Visit

    Time frame: Baseline to Visit 5

  4. Change in SNAP-IV ADHD scores

    Time frame: Baseline to Visit 5

Sponsors and collaborators

Lead sponsor

Supernus Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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)

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 2, 2011
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.