Clinical trial NCT01364662: 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)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Impulsive Aggression Comorbid With ADHD
Keywords: Impulsive Aggression
Attention Deficit Hyperactivity Disorder
ADHD
Lead sponsor: Supernus Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-02
Enrollment: 121
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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)

Primary outcomes:
measure: Reduction in aggressive behavior as assessed by R-MOAS score
timeFrame: Change from baseline to Visit 10
Secondary outcomes:
measure: Safety of SPN-810 Safety as assessed by safety scales, AEs, clinical labs, vitals, Physical Exams, and ECGs
timeFrame: Visit 2 to End of Study
measure: Change in CGI-S
timeFrame: Baseline to Visit 5
measure: CGI-I score at each post-baseline Visit
timeFrame: Baseline to Visit 5
measure: Change in SNAP-IV ADHD scores
timeFrame: Baseline to Visit 5
Other outcomes:
Locations:
city: Dothan
country: United States
state: Alabama
city: Los Angeles
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Bradenton
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Maitland
country: United States
state: Florida
city: North Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Libertyville
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Terre Haute
country: United States
state: Indiana
city: Owensboro
country: United States
state: Kentucky
city: Toms River
country: United States
state: New Jersey
city: Stony Brook
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Bellevue
country: United States
state: Washington
city: Bothell
country: United States
state: Washington
Study officials:
References: