CompletedPhase 2

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)

United States121 participantsStarted 2011-06

Plain-language 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.

Who can participate

Age range6 Years – 12 Years

SexALL

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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)

What they're measuring

Reduction in aggressive behavior as assessed by R-MOAS score

Timeframe: Change from baseline to Visit 10

Trial details

NCT IDNCT01364662

SponsorSupernus Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-10

View on ClinicalTrials.gov More Impulsive Aggression Comorbid With ADHD trials