This is an open label 26 week extension study for subjects who completed SEP360-202.
This is an open-label, flexibly-dosed, 26 week extension study in children and adolescents with ADHD who have completed 6 weeks of double-blind treatment in the core study (SEP360 202). This study will evaluate the long-term safety and tolerability of dasotraline in this population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
237
Dasotraline 2 mg, 4 mg, 6 mg, once daily, flexibly dosed
The Incidence of Overall Adverse Events, AEs , Serious Adverse Envents,(or SAEs), and AEs (or SAEs) Leading to Discontinuation
Overall adverse events, AEs , serious adverse envents,(or SAEs), and AEs (or SAEs) leading to discontinuation.
Time frame: 26 Weeks
Change From Baseline, in Attention Deficit Hyperactivity Disorder Rating Scale, Version IV, Home Version, (ADHD RS IV HV) Total Score.
The ADHD RS-IV HV is a validated scale that consists of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria and is also consistent with DSM-5 criteria. Each item is scored from a range of zero (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from zero to 54. The 18 items may be grouped into 2 subscales: hyperactivity/impulsivity (even number items 2 through 18) and inattentiveness (odd number items 1 through 17).
Time frame: 26 Weeks
Change From Baseline, in Clinical Global Impression-Severity of Illness (CGI S) Score.
The CGI-S scale, modified captures the clinician's rating of observed and reported ADHD symptoms, behavior, and function over the past 7 days. The CGI-S is rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill subjects.
Time frame: 26 weeks
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