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Dasotraline

DRUG8 trials

Sponsors

Sumitomo Pharma America, Inc.

Conditions

Adult Attention Deficit Hyperactivity DisorderAttention Deficit Hyperactivity DisorderAttention Deficit Hyperactivity Disorder (ADHD)Attention-Deficit Hyperactivity Disorder (ADHD)Binge Eating DisorderBinge-Eating Disorder Disorder

Phase 1

Study of the What the Body Does to the Drug in Subjects With Mild, Moderate, and Severe Liver Dysfunction
CompletedNCT02795637
Sumitomo Pharma America, Inc.Attention Deficit Hyperactivity Disorder (ADHD), Binge-Eating Disorder Disorder
Start: 2016-05-31End: 2016-11-30Updated: 2016-12-02

Phase 2

Dasotraline Pediatric ADHD Study
CompletedNCT02428088
Sumitomo Pharma America, Inc.Attention Deficit Hyperactivity Disorder
Start: 2015-04-30End: 2016-07-31Updated: 2021-03-18
Dasotraline Binge Eating Disorder Study
CompletedNCT02564588
Sumitomo Pharma America, Inc.Binge Eating Disorder
Start: 2015-10-31End: 2016-10-31Updated: 2017-09-28

Phase 3

Open-label Safety Study in Adults With ADHD
CompletedNCT02160262
Sumitomo Pharma America, Inc.Adult Attention Deficit Hyperactivity Disorder
Start: 2014-06-30End: 2016-05-31Updated: 2017-05-02
Dasotraline Adult ADHD Study
CompletedNCT02276209
Sumitomo Pharma America, Inc.Adult Attention Deficit Hyperactivity Disorder
Start: 2014-12-31End: 2016-09-30Updated: 2017-08-28
Dasotraline Pediatric Extension Study
CompletedNCT02457819
Sumitomo Pharma America, Inc.Attention Deficit Hyperactivity Disorder
Start: 2015-06-30End: 2017-02-02Updated: 2020-01-28
Dasotraline Binge Eating Disorder Extension Study
CompletedNCT02684279
Sumitomo Pharma America, Inc.Binge Eating Disorder
Start: 2016-02-29End: 2019-06-24Updated: 2020-08-12
A Study to Evaluate the Efficacy and Safety of Dasotraline in Children 6 to 12 Years Old With Attention-Deficit Hyperactivity Disorder (ADHD) in a Simulated Classroom Setting.
CompletedNCT03231800
Sumitomo Pharma America, Inc.Attention-Deficit Hyperactivity Disorder (ADHD)
Start: 2017-07-31End: 2019-03-15Updated: 2020-07-08

Related Papers

Characterization of the Safety Profile of the Triple Monoamine Reuptake Inhibitor Dasotraline Based on Clinical Trial Data and Disproportionality Analyses of Four Related Pharmacological Classes Using Real-World Data from the FDA Adverse Event Reporting System.
2026-02-16
A Randomized, Placebo-Controlled Laboratory Classroom Study of the Efficacy and Safety of Dasotraline in Children With ADHD
Journal of Attention Disorders2022-01-205 citations
Efficacy and Safety of Dasotraline in Adults With Binge-Eating Disorder
The Journal of Clinical Psychiatry2020-09-0428 citations
168 Effect of Dasotraline on Body Weight in Patients with Binge-Eating Disorder
CNS Spectrums2020-04-014 citations
169 Dasotraline for Treatment of Adults with Binge-Eating Disorder: Effect on Binge-related Obsessions and Compulsions
CNS Spectrums2020-04-011 citations
113 Dasotraline for the Treatment of Moderate to Severe Binge Eating Disorder in Adults: Results From a Randomized, Double-Blind, Placebo-Controlled Study
CNS Spectrums2018-02-0110 citations
179 Dasotraline in Children With Attention Deficit Hyperactivity Disorder: Results of a Randomized, Double-Blind, Placebo-Controlled Study
CNS Spectrums2018-02-01
Pharmacokinetics and Exposure-Response Relationships of Dasotraline in the Treatment of Attention-Deficit/Hyperactivity Disorder in Adults
Clinical Drug Investigation2015-11-2330 citations