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)
1 other identifier
interventional
121
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2011
Shorter than P25 for phase_2
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedFirst Posted
Study publicly available on registry
June 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedFebruary 11, 2021
November 1, 2015
1.3 years
May 25, 2011
February 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in aggressive behavior as assessed by R-MOAS score
Change from baseline to Visit 10
Secondary Outcomes (4)
Safety of SPN-810 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
Study Arms (4)
1
EXPERIMENTAL2
EXPERIMENTAL3
EXPERIMENTAL4
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Unknown Facility
Dothan, Alabama, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Santa Ana, California, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Bradenton, Florida, United States
Unknown Facility
Gainesville, Florida, United States
Unknown Facility
Hialeah, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Maitland, Florida, United States
Unknown Facility
North Miami, Florida, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Libertyville, Illinois, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Terre Haute, Indiana, United States
Unknown Facility
Owensboro, Kentucky, United States
Unknown Facility
Toms River, New Jersey, United States
Unknown Facility
Stony Brook, New York, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Pittsburgh, Pennsylvania, United States
Unknown Facility
Charleston, South Carolina, United States
Unknown Facility
Memphis, Tennessee, United States
Unknown Facility
Bellevue, Washington, United States
Unknown Facility
Bothell, Washington, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2011
First Posted
June 2, 2011
Study Start
June 1, 2011
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
February 11, 2021
Record last verified: 2015-11