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)

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01364662

Enrollment

121

Registered

2011-06-02

Start date

2011-06-30

Completion date

2012-10-31

Last updated

2021-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impulsive Aggression Comorbid With ADHD

Keywords

Impulsive Aggression, Attention Deficit Hyperactivity Disorder, ADHD

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.

Interventions

DRUGSPN-810

administered orally

DRUGPlacebo

administered orally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to 12 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Reduction in aggressive behavior as assessed by R-MOAS score	Change from baseline to Visit 10

Secondary

Measure	Time frame	Description
Safety of SPN-810 Safety as assessed by safety scales, AEs, clinical labs, vitals, Physical Exams, and ECGs	Visit 2 to End of Study	Safety as assessed by safety scales, AEs, clinical labs, vitals, Physical Exams, and ECGs
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026