Binge Eating DisorderPhase 2/3NCT02564588
Dasotraline Binge Eating Disorder Study
A Phase 2/3 study testing Dasotraline in people with Binge Eating Disorder, run by Sumitomo Pharma America, Inc. at 43 sites in United States.
Trial summary
Evaluate the efficacy of flexibly-dosed dasotraline compared with placebo in adults with moderate to severe Binge Eating Disorder (BED) Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Binge Eating Disorder
- What is being tested?
- Dasotraline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 319 participants
- Where
- 43 sitesUnited States
- Study dates
- Oct 2015to Oct 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female subject between 18 and 55 years of age, inclusive, at time of informed consent.
- Subject meets the following DSM 5 criteria for a diagnosis of BED. An episode of binge eating is characterized by both:
- Eating an amount of food larger than what most people would eat, in a discrete period of time (eg, 2 hours)
- Sense of lack of control over eating episode
- Binge-eating episodes are associated with ≥ 3 of the following:
- Eating much more rapidly than normal
Show all 19Show fewer
- Eating until uncomfortably full
- Eating large amounts when not feeling hungry
- Eating alone because of embarrassment
- Feeling disgusted with oneself, guilty afterward
- Binge-eating episodes are also associated with marked distress regarding the episode and not associated with recurrent use of compensatory behavior (eg, bulimia nervosa).
- Diagnosis is confirmed based on the eating-disorders module of the SCID, clinician review of subject diaries, and the EDE Q.
- Subject has a BED diagnosis including at least 2 binge eating days a week for at least 6 months prior to screening.
- Subject's BED is of at least moderate severity.
- Subject has a negative breath alcohol test and a negative urine drug screen (UDS) for any illicit drug.
- Female subject must have a negative serum pregnancy test at screening; females who are post-menopausal (defined as at least 12 months of spontaneous amenorrhea) and those who have undergone hysterectomy or bilateral oophorectomy will be exempted from the pregnancy test.
- Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to use an effective and medically acceptable form of birth control throughout the study period. Note: Continued use of an effective and medically acceptable form of birth control is recommended for 30 days after study completion.
- Subject must be able to comply with study drug administration and adhere to protocol requirements.
- Subject can read well enough to understand the informed consent form and other subject materials.
Who cannot join
- Subject has body weight index (BMI) of 18 kg/m2or less or greater than 45 kg/m2.
- Subject has a lifetime history or current symptoms of bulimia nervosa or anorexia nervosa.
- Subject has started psychotherapy (eg, supportive psychotherapy, cognitive behavior therapy, interpersonal therapy) within 3 months prior to screening. Note: Subjects receiving stable ongoing psychotherapy for longer than 3 months are permitted to enroll.
- Subject is participating in a formal weight loss program (eg, Weight Watchers®) within 3 months prior to screening.
- Subject has used a psychostimulant or mood stabilizer within the 3 months prior to screening.
- Subject has used any medications for the treatment of binge eating, other eating disorders, obesity, or weight gain or any other medication that could result in weight gain or weight loss including over-the-counter and herbal products within the 3 months prior to screening.
Show all 32Show fewer
- Subject has a lifetime history of psychotic disorder, bipolar disorder, hypomania, dementia, or ADHD as defined by the DSM 5 criteria.
- Subject has a history of moderate to severe depression based on investigator's judgment within the 6 months prior to screening or is currently taking or has taken any medication for depression during the 3 months prior to screening.
- Subject has a history of substance use disorder including alcohol use disorder (excluding nicotine and caffeine) within the 12 months prior to screening, as defined by the DSM 5 criteria.
- Subject has MADRS score ≥ 18 at screening and Baseline visit.
- Subject is considered a suicide risk or has any previous history of suicide attempt.
- Subject answers "yes" to "suicidal ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C SSRS assessment at screening (in the past month). Subjects who answer "yes" to this question must be referred to the Investigator for follow up evaluation.
- Subject has type I diabetes mellitus or insulin-dependent diabetes mellitus.
- Subject with type II diabetes mellitus has hemoglobin A1c ≥ 6.5% at screening, or has initiated treatment with or changed the dose of a glucose-lowering agent within 3 months prior to screening.
- Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, documented heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems.
- Subject has initiated treatment with or changed the dose of a lipid-lowering medication within the 3 months prior to screening.
- Subject has a history of moderate or severe hypertension that in the investigator's opinion has not been medically stable or has required a change in dosage and/or medication during the 3 months prior to screening.
- Subject has a history of epilepsy, seizures (except childhood febrile seizures), unexplained syncope or other unexplained blackouts (except single incident), or head trauma with loss of consciousness lasting more than 5 minutes, or a history of clinically significant repeated head-traumas without loss of consciousness.
- Subject is female and pregnant or nursing.
- Subject has had bariatric surgery, lap bands, duodenal stents, or other procedures for weight loss.
- Subject has a history of positive test for Hepatitis B surface antigen or Hepatitis C antibody with liver function test results at screening above the upper limit of normal (ULN) for the reference laboratory.
- Subject without a history of positive test for Hepatitis B surface antigen or Hepatitis C antibody has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value ≥ 2 times the ULN at screening.
- Subject has a blood urea nitrogen (BUN) value ≥ 1.5 times the ULN for the reference range, fasting blood glucose ≥ 126 mg/dL (7.0 mmol/L), or hemoglobin A1c ≥ 6.5% at screening.
- Subject is known to have tested positive for human immunodeficiency virus (HIV).
- Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, ECG, or laboratory tests that the investigator considers to be inappropriate to allow participation in the study.
- The subject's screening ECG shows a corrected QT interval using Fridericia's formula (QTcF) of ≥ 450 msec for male subjects or ≥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.
- Subject has any life-time history of abuse or diversion of stimulants.
- Subject has a history of allergic reaction or has a known or suspected sensitivity to any substance that is contained in the study drug formulation.
- Subject has enrolled in any Phase 2 or 3 trial of psychostimulants including lisdexamfetamine dimesylate (Vyvanse®) for binge-eating disorder.
- Subject is currently participating or has participated in any clinical trial within the last 90 days or has participated in more than 2 clinical trials within the past year. This includes studies using marketed compounds or devices.
- Subject has previously been enrolled in a clinical trial of dasotraline (SEP 225289).
- Subject is an investigational site staff member or the relative of an investigational site staff member.
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
United States43 sites
Radiant Research, Inc.
Akron, Ohio, 44311
Lehigh Center For Clinical Research
Allentown, Pennsylvania, 18104
Institute of Advanced Medical Research
Alpharetta, Georgia, 30005
Radiant Research, Inc.
Anderson, South Carolina, 29621
Neurotrials Research, INC.
Atlanta, Georgia, 30342
McLean Hospital
Belmont, Massachusetts, 02478
Southern California Research
Beverly Hills, California, 90210
Southwestern Research, Inc.
Beverly Hills, California, 90210
Patient Priority Clinical Sites
Cincinnati, Ohio, 45215
Furturesearch Trials of Dallas
Dallas, Texas, 75231
Midwest Clinical Research Center
Dayton, Ohio, 45417
Lytle and Weiss, PLLC
Denver, Colorado, 80209
Pharmacology Research Institute
Encino, California, 91316
Collaborative NeuroScience Network Inc.
Garden Grove, California, 92845
Radiant Research, Inc.
Greer, South Carolina, 29650
NeuroScience, Inc.
Herndon, Virginia, 20170
Texas Center for Drug Development, Inc.
Houston, Texas, 77081
Goldpoint Clinical Research, Inc.
Indianapolis, Indiana, 46260
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256
Capstone Clinical Research
Libertyville, Illinois, 60048
Lindner Center Of Hope
Mason, Ohio, 45040
Sunstone Medical Research, LLC
Medford, Oregon, 97504
North Star Medical Research, LLC
Middleburg Heights, Ohio, 44130
Bioscience Research, LLC
Mount Kisco, New York, 10549
Radiant Research, Inc.
Murray, Utah, 84123
Pharmacology Research Institute
Newport Beach, California, 92660
Segal Institute for Clinical Research
North Miami, Florida, 33161
Advanced Research Institute
Ogden, Utah, 84405
IPS Research Company
Oklahoma City, Oklahoma, 73103
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
Psychiatric Medical Associates
Plano, Texas, 75093
Oregon Center for Clinical Investigatons, INC.
Portland, Oregon, 97214
Princeton Medical Institute, LCC
Princeton, New Jersey, 08540
Wake Research Associates
Raleigh, North Carolina, 27612
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, 63304
Oregon Center for Clinical Investigatons, INC.
Salem, Oregon, 97301
PCSD- Feighner Research
San Diego, California, 92108
Research Across America
Santa Ana, California, 92705
Summit Research Network (Seattle) LLC
Seattle, Washington, 98104
Miami Research Associates
South Miami, Florida, 33143
Adams Clinical Trials, LLC
Watertown, Massachusetts, 02472
Cypress Medical Research Center, LLC
Wichita, Kansas, 67226
Neuropsychiatric Associates
Woodstock, Vermont, 05091
About this study
Official title: A 12-week, Randomized, Double-blind, Parallel-group, Placebo Controlled, Flexibly Dosed, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Dasotraline in Adults With Moderate to Severe Binge Eating Disorder
Evaluate the efficacy of flexibly-dosed dasotraline compared with placebo in adults with moderate to severe Binge Eating Disorder (BED)
Read the detailed description
This is a randomized, double blind, parallel group, multicenter, outpatient study evaluating the efficacy and safety of flexibly-dosed dasotraline in adults with BED using dasotraline (4, 6, and 8 mg/day) versus placebo over a 12 week treatment period.
- Conditions
- Binge Eating Disorder
- Being tested
- Dasotraline, Placebo
- Medical subject headings
- Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasotralineDrug
Dasotraline 4, 6, 8mg flexibly dosed once daily
PlaceboDrug
Placebo once daily
| Study group | Role | What they receive |
|---|---|---|
| Dasotraline | Experimental | Dasotraline 4, 6, 8 mg Receives: Drug: Dasotraline |
| Placebo | Placebo comparator | Placebo Comparator Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in number of binge days (defined as days during which at least 1 binge episode occurs) per week to Week 12
Measured: 12 Weeks
Secondary outcomes (21)
Change from baseline in number of binge episodes per week to Weeks 1, 2, 3, 4, 6, 8, 10, and 12
Measured: 12 Weeks
Percent of subjects with a 4-week cessation from binge eating (defined as a 100% reduction for at least 28 consecutive days in the number of binge eating episodes prior to the EOT visit)
Measured: 4 weeks
Change from baseline in Clinical Global Impression-Severity (CGI S) score at Weeks 2, 4, 6, 8, 10, and 12
Measured: 12 Weeks
Change from baseline in Eating Disorder Examination Questionnaire Brief Version (EDE Q7) global score and 3 subscale scores (dietary restraint, shape/weight overvaluation, and body dissatisfaction) at Weeks 4, 8, and 12
Measured: 12 Weeks
Change from baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y BOCS BE) total score and subscale scores (obsessions and compulsions) at Weeks 2, 4, 6, 8, 10, and 12
Measured: 12 Weeks
Change from baseline in Sheehan disability Scale (SDS) total score and subscale scores (school/work disability, social life disability, and family life disability at Week 12
Measured: 12 Weeks
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 12
Measured: 12 Weeks
Change from baseline in Hamilton Anxiety Rating Scale (HAM A) score at Week 12
Measured: 12 Weeks
Change from baseline in Medical Outcomes Study 12 Item Short Form (SF 12) two component scores (physical component, mental health component) at Week 12
Measured: 12 Weeks
Proportion of binge-eating responders who have ≥ 75% reduction in the number of binge eating episodes from Baseline at Week 12
Measured: 12 weeks
Proportion of binge-eating responders who have ≥ 50% reduction in the number of binge eating episodes from Baseline at Week 12
Measured: 12 Weeks
The incidence of overall AEs, serious AEs (SAEs), and AEs (or SAEs) leading to discontinuations
Measured: 12 Weeks
Clinical laboratory evaluations (serum chemistry, hematology, and urinalysis)
Measured: 12 Weeks
Clinical evaluations (vital signs, orthostatic effects, and 12 lead ECGs)
Measured: 12 Weeks
Frequency and severity of suicidal ideation and suicidal behavior as assessed by the Columbia-suicide severity rating scale (C SSRS)
Measured: 12 Weeks
Change and percent change from baseline in body weight at Weeks 1, 2, 3, 4, 6, 8, 10, and 12
Measured: 12 Weeks
Change and percent change from baseline in BMI at Weeks 1, 2, 3, 4, 6, 8, 10, and 12
Measured: 12 Weeks
Change from baseline in a fasting lipid panel (triglycerides, total cholesterol, high-density lipoprotein [HDL] cholesterol, and low-density lipoprotein [LDL] cholesterol) at Weeks 6 and 12
Measured: 12 Weeks
Change from baseline in hemoglobin A1c level at Weeks 6 and 12
Measured: 12 Weeks
Change from baseline in fasting glucose level at Weeks 6 and 12
Measured: 12 Weeks
Change in the symptoms of withdrawal from Week 12/end of treatment (EOT) as measured by: - CSSA scores at Weeks 13, 14, and 15 - DESS scores at Weeks 13, 14, and 15 - HAM A scores at Weeks 13, 14, and 15 - MADRS scores at Weeks 13, 14, and 15.
The change in symptoms of withdrawal is a time frame of 3 weeks after treatment ends (weeks 13, 14, 15)
Measured: 3 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Binge Eating DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dasotraline Medical Director, MD, Study director, Sunovioin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02564588
- Sponsor's protocol ID
- SEP360-221
- Status last verified
- Sep 2017
- First submitted
- 29 Sep 2015
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gumenyuk S, Ogirala A, Szabo ST, Koblan K, Hopkins SC, Ufer M. 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. Clin Drug Investig. 2026 Apr;46(4):455-465. doi: 10.1007/s40261-026-01525-3. Epub 2026 Feb 16.
PubMed 41697570McElroy SL, Hudson JI, Grilo CM, Guerdjikova AI, Deng L, Koblan KS, Goldman R, Navia B, Hopkins S, Loebel A. Efficacy and Safety of Dasotraline in Adults With Binge-Eating Disorder: A Randomized, Placebo-Controlled, Flexible-Dose Clinical Trial. J Clin Psychiatry. 2020 Sep 8;81(5):19m13068. doi: 10.4088/JCP.19m13068.
PubMed 32926604
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week, Randomized, Double-blind, Parallel-group, Placebo Controlled, Flexibly Dosed, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Dasotraline in Adults With Moderate to Severe Binge Eating Disorder
- ClinicalTrials.gov ID
- NCT02564588
- Acronym / sponsor ID
- SEP360-221
- Conditions
- Binge Eating Disorder
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 30 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the efficacy of flexibly-dosed dasotraline compared with placebo in adults with moderate to severe Binge Eating Disorder (BED)
Detailed description
This is a randomized, double blind, parallel group, multicenter, outpatient study evaluating the efficacy and safety of flexibly-dosed dasotraline in adults with BED using dasotraline (4, 6, and 8 mg/day) versus placebo over a 12 week treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dasotraline | Experimental | Drug: DasotralineDasotraline 4, 6, 8 mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Comparator |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Male or female subject between 18 and 55 years of age, inclusive, at time of informed consent.
- Subject meets the following DSM 5 criteria for a diagnosis of BED. An episode of binge eating is characterized by both:
- Eating an amount of food larger than what most people would eat, in a discrete period of time (eg, 2 hours)
- Sense of lack of control over eating episode
- Binge-eating episodes are associated with ≥ 3 of the following:
Key exclusion criteria (32 listed)
- Subject has body weight index (BMI) of 18 kg/m2or less or greater than 45 kg/m2.
- Subject has a lifetime history or current symptoms of bulimia nervosa or anorexia nervosa.
- Subject has started psychotherapy (eg, supportive psychotherapy, cognitive behavior therapy, interpersonal therapy) within 3 months prior to screening. Note: Subjects receiving stable ongoing psychotherapy for longer than 3 months are permitted to enroll.
- Subject is participating in a formal weight loss program (eg, Weight Watchers®) within 3 months prior to screening.
- Subject has used a psychostimulant or mood stabilizer within the 3 months prior to screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DasotralineDasotraline 4, 6, 8mg flexibly dosed once daily | Drug | Dasotraline |
| PlaceboPlacebo once daily | Drug | Placebo |
Primary outcome
Change from baseline in number of binge days (defined as days during which at least 1 binge episode occurs) per week to Week 12
Time frame: 12 Weeks
21 secondary outcomes
Change from baseline in number of binge episodes per week to Weeks 1, 2, 3, 4, 6, 8, 10, and 12
Time frame: 12 Weeks
Percent of subjects with a 4-week cessation from binge eating (defined as a 100% reduction for at least 28 consecutive days in the number of binge eating episodes prior to the EOT visit)
Time frame: 4 weeks
Change from baseline in Clinical Global Impression-Severity (CGI S) score at Weeks 2, 4, 6, 8, 10, and 12
Time frame: 12 Weeks
Change from baseline in Eating Disorder Examination Questionnaire Brief Version (EDE Q7) global score and 3 subscale scores (dietary restraint, shape/weight overvaluation, and body dissatisfaction) at Weeks 4, 8, and 12
Time frame: 12 Weeks
Change from baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y BOCS BE) total score and subscale scores (obsessions and compulsions) at Weeks 2, 4, 6, 8, 10, and 12
Time frame: 12 Weeks
Change from baseline in Sheehan disability Scale (SDS) total score and subscale scores (school/work disability, social life disability, and family life disability at Week 12
Time frame: 12 Weeks
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 12
Time frame: 12 Weeks
Change from baseline in Hamilton Anxiety Rating Scale (HAM A) score at Week 12
Time frame: 12 Weeks
Change from baseline in Medical Outcomes Study 12 Item Short Form (SF 12) two component scores (physical component, mental health component) at Week 12
Time frame: 12 Weeks
Proportion of binge-eating responders who have ≥ 75% reduction in the number of binge eating episodes from Baseline at Week 12
Time frame: 12 weeks
Proportion of binge-eating responders who have ≥ 50% reduction in the number of binge eating episodes from Baseline at Week 12
Time frame: 12 Weeks
The incidence of overall AEs, serious AEs (SAEs), and AEs (or SAEs) leading to discontinuations
Time frame: 12 Weeks
Clinical laboratory evaluations (serum chemistry, hematology, and urinalysis)
Time frame: 12 Weeks
Clinical evaluations (vital signs, orthostatic effects, and 12 lead ECGs)
Time frame: 12 Weeks
Frequency and severity of suicidal ideation and suicidal behavior as assessed by the Columbia-suicide severity rating scale (C SSRS)
Time frame: 12 Weeks
Change and percent change from baseline in body weight at Weeks 1, 2, 3, 4, 6, 8, 10, and 12
Time frame: 12 Weeks
Change and percent change from baseline in BMI at Weeks 1, 2, 3, 4, 6, 8, 10, and 12
Time frame: 12 Weeks
Change from baseline in a fasting lipid panel (triglycerides, total cholesterol, high-density lipoprotein [HDL] cholesterol, and low-density lipoprotein [LDL] cholesterol) at Weeks 6 and 12
Time frame: 12 Weeks
Change from baseline in hemoglobin A1c level at Weeks 6 and 12
Time frame: 12 Weeks
Change from baseline in fasting glucose level at Weeks 6 and 12
Time frame: 12 Weeks
Change in the symptoms of withdrawal from Week 12/end of treatment (EOT) as measured by: - CSSA scores at Weeks 13, 14, and 15 - DESS scores at Weeks 13, 14, and 15 - HAM A scores at Weeks 13, 14, and 15 - MADRS scores at Weeks 13, 14, and 15.
Time frame: 3 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
- Derived from this study: PubMed 41697570Gumenyuk S, Ogirala A, Szabo ST, Koblan K, Hopkins SC, Ufer M. 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. Clin Drug Investig. 2026 Apr;46(4):455-465. doi: 10.1007/s40261-026-01525-3. Epub 2026 Feb 16.
- Derived from this study: PubMed 32926604McElroy SL, Hudson JI, Grilo CM, Guerdjikova AI, Deng L, Koblan KS, Goldman R, Navia B, Hopkins S, Loebel A. Efficacy and Safety of Dasotraline in Adults With Binge-Eating Disorder: A Randomized, Placebo-Controlled, Flexible-Dose Clinical Trial. J Clin Psychiatry. 2020 Sep 8;81(5):19m13068. doi: 10.4088/JCP.19m13068.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dasotraline Medical Director, MD study director
Sunovioin
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dasotraline in people with Binge Eating Disorder, run by Sumitomo Pharma America, Inc. at 43 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in number of binge days (defined as days during which at least 1 binge episode occurs) per week to Week 12 (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02564588, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2017.