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)

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Impulsive Aggression Comorbid With ADHD

Intervention / Treatment
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* Drug: SPN-810
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Placebo<br>* administered orally<br>|
| Experimental: 2<br> | Drug: SPN-810<br>* administered orally<br>|
| Experimental: 3<br> | Drug: SPN-810<br>* administered orally<br>|
| Experimental: 4<br> | Drug: SPN-810<br>* administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Impulsive Aggression, Attention Deficit Hyperactivity Disorder, ADHD