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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:
ClinicalTrials.gov Identifier:
NCT01364662
First Posted: June 2, 2011
Last Update Posted: December 15, 2015
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.
Information provided by (Responsible Party):
Supernus Pharmaceuticals, Inc.
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Safety [ Time Frame: after approximately 6 weeks ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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
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): 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
First Submitted: May 25, 2011
First Posted: June 2, 2011
Last Update Posted: December 15, 2015
Last Verified: November 2015

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