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)
NCT ID: NCT01364662
Last Updated: 2021-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
121 participants
INTERVENTIONAL
2011-06-30
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Placebo
administered orally
2
SPN-810
administered orally
3
SPN-810
administered orally
4
SPN-810
administered orally
Interventions
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SPN-810
administered orally
Placebo
administered orally
Eligibility Criteria
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Inclusion Criteria
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)
6 Years
12 Years
ALL
No
Sponsors
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Supernus Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Dothan, Alabama, United States
Los Angeles, California, United States
Santa Ana, California, United States
Washington D.C., District of Columbia, United States
Bradenton, Florida, United States
Gainesville, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Maitland, Florida, United States
North Miami, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Libertyville, Illinois, United States
Indianapolis, Indiana, United States
Terre Haute, Indiana, United States
Owensboro, Kentucky, United States
Toms River, New Jersey, United States
Stony Brook, New York, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Memphis, Tennessee, United States
Bellevue, Washington, United States
Bothell, Washington, United States
Countries
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Other Identifiers
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810P202
Identifier Type: -
Identifier Source: org_study_id
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