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)

Impulsive Aggression Comorbid With ADHD Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01364662
• Other study ID #: 810P202
• Status: Completed
• Phase: Phase 2
• Start date: June 2011
• Est. completion date: October 2012

Study information

• Verified date: November 2015
• Source: Supernus Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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)

Related Conditions & MeSH terms

• Aggression
• Attention Deficit Disorder with Hyperactivity
• Hyperkinesis
• Impulsive Aggression Comorbid With ADHD
• Impulsive Behavior

Intervention

Drug:
• SPN-810
administered orally
• Placebo
administered orally

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Supernus Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in aggressive behavior as assessed by R-MOAS score		Change from baseline to Visit 10
Secondary	Safety of SPN-810 Safety as assessed by safety scales, AEs, clinical labs, vitals, Physical Exams, and ECGs	Safety as assessed by safety scales, AEs, clinical labs, vitals, Physical Exams, and ECGs	Visit 2 to End of Study
Secondary	Change in CGI-S		Baseline to Visit 5
Secondary	CGI-I score at each post-baseline Visit		Baseline to Visit 5
Secondary	Change in SNAP-IV ADHD scores		Baseline to Visit 5