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)

Supernus Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Impulsive Aggression Comorbid With ADHD

Treatments: Drug: Placebo; Drug: SPN-810

Study type: Interventional

Funder types: Industry

Identifiers

NCT01364662

810P202

Details and patient eligibility

About

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.

Enrollment: 121 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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121 participants in 4 patient groups

1

Experimental group

Treatment:

Drug: Placebo

2

Experimental group

Treatment:

Drug: SPN-810

3

Experimental group

Treatment:

Drug: SPN-810

4

Experimental group

Treatment:

Drug: SPN-810