333
Participants
Start Date
January 25, 2016
Primary Completion Date
September 4, 2019
Study Completion Date
October 24, 2019
SPN-810 (18 mg)
Subjects were randomized to receive SPN-810 low dose (18 mg) twice each day (BID) with or without food, in the morning and in the evening, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if after noon, the evening dose.
SPN-810 (36 mg)
Subjects were randomized to receive SPN-810 high dose (36 mg) twice each day (BID) with or without food, in the morning and in the evening, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if after noon, the evening dose.
Placebo
Subjects were randomized to receive Placebo twice each day (BID) with or without food, in the morning and in the evening, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if after noon, the evening dose.
Finger Lakes Clinical Research, Rochester
Hugo W Moser Research Institute at Kennedy Krieger, Baltimore
Alliance Research Group, LLC., Richmond
Carolina Clinical Trials, Inc., Charleston
Sarkis Clinical Trials, Gainesville
Florida Clinical Research Center, LLC., Maitland
CNS Healthcare of Orlando, Orlando
Meridien Research at Florida Clinical Research Center, Bradenton
CNS Healthcare, Memphis
Research Strategies of Memphis, LLC, Memphis
Ohio State University Nisonger Center Clinical Trials Program, Columbus
Capstone Clinical Research, Libertyville
American Medical Research, Chicago
Psychiatric Associates, Overland Park
Woodland Research Northwest, Rogers
Oklahoma Clinical Research Center, Oklahoma City
Paradigm Research Professionals, Oklahoma City
Relaro Medical Trials, Dallas
Bayou City Research Corporation, Houston
Family Psychiatry of the Woodlands, The Woodlands
Clinical Trials of Texas, Inc., San Antonio
Road Runner Research, San Antonio
Aspen Clinical Research, Orem
ProScience, Culver City
Behavioral Research Specialists, Glendale
Neuropsychiatric Research Center of Orange County, Orange
Cyn3rgy Research, Gresham
Seattle Children's Research Institute, Seattle
Supernus Pharmaceuticals, Inc.
INDUSTRY