MedPath

Dasotraline

Generic Name
Dasotraline
Drug Type
Small Molecule
Chemical Formula
C16H15Cl2N
CAS Number
675126-05-3
Unique Ingredient Identifier
4D28EY0L5T
Background

Dasotraline is a serotonin, norepinephrine and dopamine reuptake inhibitor (SNDRI) that is under investigation for the treatment of Binge Eating Disorder, Adult Attention Hyperactivity Disorder, Attention Deficit Hyperactivity Disorder, and Adult Attention Deficit Hyperactivity Disorder.

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.

Phase 3
Completed
Conditions
Attention-Deficit Hyperactivity Disorder (ADHD)
Interventions
Drug: Placebo
First Posted Date
2017-07-27
Last Posted Date
2020-07-08
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
95
Registration Number
NCT03231800
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Avida Inc, Newport Beach, California, United States

๐Ÿ‡บ๐Ÿ‡ธ

Qps-Mra, Llc, South Miami, Florida, United States

๐Ÿ‡บ๐Ÿ‡ธ

South Shore Psychiatric Services PC, Hingham, Massachusetts, United States

and more 4 locations

A Study to Evaluate a Drug (Dasotraline) on the Safety, Effectiveness and How Well the Body Tolerates it, in Adults With Moderate to Severe Binge Eating Disorder

Phase 3
Completed
Conditions
Binge Eating Disorder
Interventions
First Posted Date
2017-04-11
Last Posted Date
2020-07-13
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
491
Registration Number
NCT03107026
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Lytle and Weiss PLLC, Denver, Colorado, United States

๐Ÿ‡บ๐Ÿ‡ธ

Clinical Neuroscience Solutions, Inc., Memphis, Tennessee, United States

๐Ÿ‡บ๐Ÿ‡ธ

Bioscience Research, LLC, Mount Kisco, New York, United States

and more 43 locations

Study of the What the Body Does to the Drug in Subjects With Mild, Moderate, and Severe Liver Dysfunction

Phase 1
Completed
Conditions
Attention Deficit Hyperactivity Disorder (ADHD)
Binge-Eating Disorder Disorder
Interventions
First Posted Date
2016-06-10
Last Posted Date
2016-12-02
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
44
Registration Number
NCT02795637
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Clinical Pharmacology of Miami, Inc., Miami, Florida, United States

๐Ÿ‡บ๐Ÿ‡ธ

DaVita Clinical Research, Minneapolis, Minnesota, United States

๐Ÿ‡บ๐Ÿ‡ธ

Orlando Clinical Research Center, Orlando, Florida, United States

and more 2 locations

A Study to Evaluate the Efficacy and Safety of Dasotraline in Children 6 to 12 Years of Age With Attention-Deficit Hyperactivity Disorder (ADHD) in a Simulated Classroom Setting.

Phase 3
Completed
Conditions
Attention-Deficit Hyperactivity Disorder (ADHD)
Interventions
Other: Placebo
First Posted Date
2016-04-12
Last Posted Date
2020-03-27
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
132
Registration Number
NCT02734693
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Avida Inc, Newport Beach, California, United States

๐Ÿ‡บ๐Ÿ‡ธ

Meridien Research, Bradenton, Florida, United States

๐Ÿ‡บ๐Ÿ‡ธ

Bayou City Research, Ltd, Houston, Texas, United States

and more 2 locations

Dasotraline Binge Eating Disorder Extension Study

Phase 3
Completed
Conditions
Binge Eating Disorder
Interventions
First Posted Date
2016-02-17
Last Posted Date
2020-08-12
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
533
Registration Number
NCT02684279
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Neuotrials Research, Inc., Atlanta, Georgia, United States

๐Ÿ‡บ๐Ÿ‡ธ

Boston Clinical Trials, Boston, Massachusetts, United States

๐Ÿ‡บ๐Ÿ‡ธ

Texas Center for Drug Development, Inc., Houston, Texas, United States

and more 49 locations

Dasotraline Binge Eating Disorder Study

Phase 2
Completed
Conditions
Binge Eating Disorder
Interventions
Drug: Placebo
First Posted Date
2015-09-30
Last Posted Date
2017-09-28
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
319
Registration Number
NCT02564588
Locations
๐Ÿ‡บ๐Ÿ‡ธ

PCSD- Feighner Research, San Diego, California, United States

๐Ÿ‡บ๐Ÿ‡ธ

Capstone Clinical Research, Libertyville, Illinois, United States

๐Ÿ‡บ๐Ÿ‡ธ

Sunstone Medical Research, LLC, Medford, Oregon, United States

and more 34 locations

Dasotraline Pediatric Extension Study

Phase 3
Completed
Conditions
Attention Deficit Hyperactivity Disorder
Interventions
First Posted Date
2015-05-29
Last Posted Date
2020-01-28
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
237
Registration Number
NCT02457819
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Psychiatric Associates, Overland Park, Kansas, United States

๐Ÿ‡บ๐Ÿ‡ธ

Harmonex Neuroscience Research, Inc, Dothan, Alabama, United States

๐Ÿ‡บ๐Ÿ‡ธ

Clinical Trials group at the Rochester Center for Behavioral Medicine, Rochester Hills, Michigan, United States

and more 32 locations

Dasotraline Pediatric ADHD Study

Phase 2
Completed
Conditions
Attention Deficit Hyperactivity Disorder
Interventions
Drug: Placebo Comparator
First Posted Date
2015-04-28
Last Posted Date
2021-03-18
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
330
Registration Number
NCT02428088
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Gulfcoast Clinical Research, Fort Myers, Florida, United States

๐Ÿ‡บ๐Ÿ‡ธ

Neurobehaviorial Medicine Group, PLLC, Bloomfield Hills, Michigan, United States

๐Ÿ‡บ๐Ÿ‡ธ

Harmonex Neuroscience Research, Dothan, Alabama, United States

and more 39 locations

Dasotraline Adult ADHD Study

Phase 3
Completed
Conditions
Adult Attention Deficit Hyperactivity Disorder
Interventions
Other: Placebo
First Posted Date
2014-10-28
Last Posted Date
2017-08-28
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
636
Registration Number
NCT02276209
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Gulfcoast Clinical Research, Fort Myers, Florida, United States

๐Ÿ‡บ๐Ÿ‡ธ

Kennedy Krieger Institute, Baltimore, Maryland, United States

๐Ÿ‡บ๐Ÿ‡ธ

Massachusetts General Hospital, Boston, Massachusetts, United States

and more 54 locations

Dasotraline SEP360-105 Pediatric PK/PD Study

Phase 1
Completed
Conditions
Pediatric Attention Deficit Hyperactivity Disorder
Interventions
First Posted Date
2014-07-21
Last Posted Date
2015-03-31
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
105
Registration Number
NCT02195167
Locations
๐Ÿ‡บ๐Ÿ‡ธ

MCB Clinical Research Centers, LLC, Colorado Springs, Colorado, United States

๐Ÿ‡บ๐Ÿ‡ธ

Palm Springs Research Institute, Hialeah, Florida, United States

๐Ÿ‡บ๐Ÿ‡ธ

iResearch Atlanta, LLC, Decatur, Georgia, United States

and more 9 locations
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