Study is to assess if TC-5619 improves symptoms for adults diagnosed with the inattentive-predominant subtype of ADHD over a 4-week treatment period.
A 3-arm, double-blind, randomized, placebo-controlled, multicenter, fixed dose study to assess efficacy and safety of TC-5619 in adults with inattentive-predominant attention deficit/hyperactivity disorder (ADHD) utilizing the Connor's Adult ADHD Rating Scale-Investigator Completed Version (CAARS-INV) inattentive subscale scores through 4 weeks of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
250
TC-5619-238 5mg capsule taken once daily for 4 weeks
TC-5619-238 25mg capsules taken once daily for 4 weeks
Placebo capsules will be taken once daily for 4 weeks
Southwestern Research, Inc
Beverly Hills, California, United States
Synergy Clinical Research Center
National City, California, United States
MCB Clinical Research Centers, LLC
Inattentive Subscale of the Conner's Adult ADHD-Investigator Version (CAARS-INV)
Scores on the inattentive subscale of the CAARS-INV obtained at Day 1 (baseline) and weeks 2, 4, and 6. Primary comparison will be difference between Day 1 and Week 4 (TC-5619 5mg and 25 mg vs. placebo).
Time frame: 4 weeks
Conner's Adult ADHD-Investigator Version total score
Scores on the total CAARS-INV obtained at Day 1 (baseline) and weeks 2, 4, and 6. Primary comparison will be difference between Day 1 and Week 4 (TC-5619 5mg and 25 mg vs. placebo).
Time frame: 4 weeks
Conner's Adult ADHD Rating Scale-Subject Self-Rating Version (CAARS-S)
Scores on the CAARS-S obtained at Day 1 (baseline) and weeks 2, 4, and 6. Primary comparison will be difference between Day 1 and Week 4 (TC-5619 5mg and 25 mg vs. placebo).
Time frame: 4 weeks
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Colorado Springs, Colorado, United States
Florida Clinical Research Center, LLC
Bradenton, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Florida Clinical Research Center, LLC
Maitland, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Compass Research, Inc.
Orlando, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
Clinical Trials Network & Institute, Massachusetts General Hospital
Boston, Massachusetts, United States
...and 4 more locations