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Dasotraline Binge Eating Disorder Study

Primary Purpose

Binge Eating Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dasotraline
Placebo
Sponsored by
Sumitomo Pharma America, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge Eating Disorder

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Sites / Locations

  • Southern California Research
  • Southwestern Research, Inc.
  • Pharmacology Research Institute
  • Collaborative NeuroScience Network Inc.
  • Pharmacology Research Institute
  • PCSD- Feighner Research
  • Research Across America
  • Lytle and Weiss, PLLC
  • Clinical Neuroscience Solutions, Inc.
  • Segal Institute for Clinical Research
  • Clinical Neuroscience Solutions, Inc.
  • Miami Research Associates
  • Institute of Advanced Medical Research
  • Neurotrials Research, INC.
  • Capstone Clinical Research
  • Goldpoint Clinical Research, Inc.
  • Cypress Medical Research Center, LLC
  • McLean Hospital
  • Adams Clinical Trials, LLC
  • St. Charles Psychiatric Associates - Midwest Research Group
  • Princeton Medical Institute, LCC
  • Bioscience Research, LLC
  • Wake Research Associates
  • Radiant Research, Inc.
  • Patient Priority Clinical Sites
  • Midwest Clinical Research Center
  • Lindner Center Of Hope
  • North Star Medical Research, LLC
  • IPS Research Company
  • Sunstone Medical Research, LLC
  • Oregon Center for Clinical Investigatons, INC.
  • Oregon Center for Clinical Investigatons, INC.
  • Lehigh Center For Clinical Research
  • Radiant Research, Inc.
  • Radiant Research, Inc.
  • Furturesearch Trials of Dallas
  • Texas Center for Drug Development, Inc.
  • Psychiatric Medical Associates
  • Radiant Research, Inc.
  • Advanced Research Institute
  • Neuropsychiatric Associates
  • NeuroScience, Inc.
  • Summit Research Network (Seattle) LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dasotraline

Placebo

Arm Description

Dasotraline 4, 6, 8 mg

Placebo Comparator

Outcomes

Primary Outcome Measures

Change from baseline in number of binge days (defined as days during which at least 1 binge episode occurs) per week to Week 12

Secondary Outcome Measures

Change from baseline in number of binge episodes per week to Weeks 1, 2, 3, 4, 6, 8, 10, and 12
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)
Change from baseline in Clinical Global Impression-Severity (CGI S) score at Weeks 2, 4, 6, 8, 10, and 12
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
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
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
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 12
Change from baseline in Hamilton Anxiety Rating Scale (HAM A) score at Week 12
Change from baseline in Medical Outcomes Study 12 Item Short Form (SF 12) two component scores (physical component, mental health component) at Week 12
Proportion of binge-eating responders who have ≥ 75% reduction in the number of binge eating episodes from Baseline at Week 12
Proportion of binge-eating responders who have ≥ 50% reduction in the number of binge eating episodes from Baseline at Week 12
The incidence of overall AEs, serious AEs (SAEs), and AEs (or SAEs) leading to discontinuations
Clinical laboratory evaluations (serum chemistry, hematology, and urinalysis)
Clinical evaluations (vital signs, orthostatic effects, and 12 lead ECGs)
Frequency and severity of suicidal ideation and suicidal behavior as assessed by the Columbia-suicide severity rating scale (C SSRS)
Change and percent change from baseline in body weight at Weeks 1, 2, 3, 4, 6, 8, 10, and 12
Change and percent change from baseline in BMI at Weeks 1, 2, 3, 4, 6, 8, 10, and 12
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
Change from baseline in hemoglobin A1c level at Weeks 6 and 12
Change from baseline in fasting glucose level at Weeks 6 and 12
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)

Full Information

First Posted
September 29, 2015
Last Updated
September 20, 2017
Sponsor
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02564588
Brief Title
Dasotraline Binge Eating Disorder 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma America, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Eating Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
319 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dasotraline
Arm Type
Experimental
Arm Description
Dasotraline 4, 6, 8 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dasotraline
Intervention Description
Dasotraline 4, 6, 8mg flexibly dosed once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo once daily
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Change from baseline in Clinical Global Impression-Severity (CGI S) score at Weeks 2, 4, 6, 8, 10, and 12
Time Frame
12 Weeks
Title
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
Title
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
Title
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
Title
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 12
Time Frame
12 Weeks
Title
Change from baseline in Hamilton Anxiety Rating Scale (HAM A) score at Week 12
Time Frame
12 Weeks
Title
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
Title
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
Title
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
Title
The incidence of overall AEs, serious AEs (SAEs), and AEs (or SAEs) leading to discontinuations
Time Frame
12 Weeks
Title
Clinical laboratory evaluations (serum chemistry, hematology, and urinalysis)
Time Frame
12 Weeks
Title
Clinical evaluations (vital signs, orthostatic effects, and 12 lead ECGs)
Time Frame
12 Weeks
Title
Frequency and severity of suicidal ideation and suicidal behavior as assessed by the Columbia-suicide severity rating scale (C SSRS)
Time Frame
12 Weeks
Title
Change and percent change from baseline in body weight at Weeks 1, 2, 3, 4, 6, 8, 10, and 12
Time Frame
12 Weeks
Title
Change and percent change from baseline in BMI at Weeks 1, 2, 3, 4, 6, 8, 10, and 12
Time Frame
12 Weeks
Title
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
Title
Change from baseline in hemoglobin A1c level at Weeks 6 and 12
Time Frame
12 Weeks
Title
Change from baseline in fasting glucose level at Weeks 6 and 12
Time Frame
12 Weeks
Title
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.
Description
The change in symptoms of withdrawal is a time frame of 3 weeks after treatment ends (weeks 13, 14, 15)
Time Frame
3 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dasotraline Medical Director, MD
Organizational Affiliation
Sunovioin
Official's Role
Study Director
Facility Information:
Facility Name
Southern California Research
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Southwestern Research, Inc.
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Pharmacology Research Institute
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Collaborative NeuroScience Network Inc.
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Pharmacology Research Institute
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
PCSD- Feighner Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Research Across America
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Lytle and Weiss, PLLC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Segal Institute for Clinical Research
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Miami Research Associates
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Institute of Advanced Medical Research
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
Neurotrials Research, INC.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Capstone Clinical Research
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
Goldpoint Clinical Research, Inc.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Cypress Medical Research Center, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
Facility Name
Adams Clinical Trials, LLC
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
St. Charles Psychiatric Associates - Midwest Research Group
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Facility Name
Princeton Medical Institute, LCC
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Bioscience Research, LLC
City
Mount Kisco
State/Province
New York
ZIP/Postal Code
10549
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Radiant Research, Inc.
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Patient Priority Clinical Sites
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45215
Country
United States
Facility Name
Midwest Clinical Research Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Lindner Center Of Hope
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
North Star Medical Research, LLC
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
IPS Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Sunstone Medical Research, LLC
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Oregon Center for Clinical Investigatons, INC.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97214
Country
United States
Facility Name
Oregon Center for Clinical Investigatons, INC.
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
Lehigh Center For Clinical Research
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Radiant Research, Inc.
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Radiant Research, Inc.
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Furturesearch Trials of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Texas Center for Drug Development, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Psychiatric Medical Associates
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Radiant Research, Inc.
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
Advanced Research Institute
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Neuropsychiatric Associates
City
Woodstock
State/Province
Vermont
ZIP/Postal Code
05091
Country
United States
Facility Name
NeuroScience, Inc.
City
Herndon
State/Province
Virginia
ZIP/Postal Code
20170
Country
United States
Facility Name
Summit Research Network (Seattle) LLC
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32926604
Citation
McElroy 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.
Results Reference
derived

Learn more about this trial

Dasotraline Binge Eating Disorder Study

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