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 study has been completed.
Sponsor:
Information provided by (Responsible Party):
Supernus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01364662
First received: May 25, 2011
Last updated: November 16, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention Phase
Impulsive Aggression Comorbid With ADHD
Drug: SPN-810
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:


Further study details as provided by Supernus Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Reduction in aggressive behavior as assessed by R-MOAS score [ Time Frame: after approximately 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: after approximately 6 weeks ] [ Designated as safety issue: Yes ]
    Safety as assessed by safety scales, AEs, clinical labs, vitals, PEs, ECGs, etc


Enrollment: 121
Study Start Date: June 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01364662

  Show 27 Study Locations
Sponsors and Collaborators
Supernus Pharmaceuticals, Inc.
  More Information

Responsible Party: Supernus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01364662     History of Changes
Other Study ID Numbers: 810P202 
Study First Received: May 25, 2011
Last Updated: November 16, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Supernus Pharmaceuticals, Inc.:
Impulsive Aggression
Attention Deficit Hyperactivity Disorder
ADHD

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Aggression
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 28, 2016