Dasotraline Pediatric Extension Study
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|ClinicalTrials.gov Identifier: NCT02457819|
Recruitment Status : Completed
First Posted : May 29, 2015
Results First Posted : January 18, 2020
Last Update Posted : January 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder||Drug: Dasotraline||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||237 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open label|
|Official Title:||An Open-label, Flexibly-dosed, 26-Week Extension Safety Study of Dasotraline in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)|
|Actual Study Start Date :||June 30, 2015|
|Actual Primary Completion Date :||February 2, 2017|
|Actual Study Completion Date :||February 2, 2017|
Dasotraline 2, 4, 6 mg
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 [ Time Frame: 26 Weeks ]Overall adverse events, AEs , serious adverse envents,(or SAEs), and AEs (or SAEs) leading to discontinuation.
- Change From Baseline, in Attention Deficit Hyperactivity Disorder Rating Scale, Version IV, Home Version, (ADHD RS IV HV) Total Score. [ Time Frame: 26 Weeks ]
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).
- Change From Baseline, in Clinical Global Impression-Severity of Illness (CGI S) Score. [ Time Frame: 26 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02457819
|Study Director:||Dasotraline Medical Director||Sunovion|