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

NCT03107026 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: SEP360-321
• Study Type: interventional
• Target: 491
• Locations: 1 country
• Sites: 50

Brief Summary

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

Conditions

Binge Eating Disorder

Keywords

Binge eating Disorder; dasotraline

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Number of Binge Days

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

  baseline and 12 Weeks

Secondary Outcomes (13)

• Change From Baseline in Binge Eating Clinical Global Impression-Severity( BE-CGI-S )Score

  baseline and 12 Weeks

• Percent of Subjects With a 4-week Cessation From Binge Eating

  up to 12 Weeks

• Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score

  baseline and 12 Weeks

• Change From Baseline in Number of Binge Days Per Week at Weeks 1, 2, 3, 4, 6, 8, and 10

  baseline and up to 10 Weeks

• Change From Baseline in Number of Binge Episodes Per Week at Weeks 1, 2, 3, 4, 6, 8, 10, and 12

  baseline and up to 12 Weeks

Study Arms (3)

dasotraline 4mg

EXPERIMENTAL

dasotraline 4mg once daily

Drug: dasotraline 4mg

dasotraline 6mg

EXPERIMENTAL

dasotraline 6mg once daily

Drug: dasotraline 6mg

Placebo

PLACEBO COMPARATOR

Placebo, once daily

Drug: Placebo

Interventions

dasotraline 4mg DRUG

dasotraline 4mg tablet once daily

Also known as: SEP225289

dasotraline 4mg

dasotraline 6mg DRUG

dasotraline 6mg tablet once daily

Also known as: SEP225289

dasotraline 6mg

Placebo DRUG

Placebo tablet once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 1. Male or female subject between 18-55 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). Note: A subject using compensatory behavior less than 1 time every 2 weeks over the 3 months prior to screening may be permitted to enroll in the study.
• \. Diagnosis is confirmed based on the Structured Clinical Interview for DSM-IV Axis I Disorders, Module H (SCID-I Module H), clinician review of subject diaries, and the EDE-Q.
• \. Subject has a BED diagnosis or is diagnosed at screening and has a history of 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 with subject reporting at least 3 binge eating days for each of the 2 weeks prior to baseline as documented in the subject's binge diary. A binge eating day is defined as having at least one binge eating episode 6. Subject has a BE- CGI-S score ≥ 4 at screening and baseline. 7. Subject has a negative breath alcohol test and a negative 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.

You may not qualify if:

• Subject has BMI of 18 kg/m2or less, or greater than 45 kg/m2.
• Subject has a lifetime history or current symptoms consistent with 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 has participated 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 received lisdexamfetamine dimesylate (Vyvanse®) for any reason, including but not limited to participation in any Phase 2 or 3 trial.
• 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 MADRS score ≥ 18 at screening and Baseline visit.
• 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 is considered a suicide risk in the investigator's opinion or has any previous history of suicide attempt within the past 12 months.
• 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.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (50)

NoesisPharma, LLC

Phoenix, Arizona, 85032, United States

Location

Southern California Research

Beverly Hills, California, 90210, United States

Location

Pharmacology Research Institute

Encino, California, 91316, United States

Location

Collaborative NeuroScience Network, LLC

Garden Grove, California, 92845, United States

Location

Pharmacology Research Institute

Newport Beach, California, 92660, United States

Location

PCSD- Feighner Research

San Diego, California, 92108, United States

Location

Artemis Institute for Clinical Research

San Marcos, California, 92708, United States

Location

Syrentis Clinical Research

Santa Ana, California, 92705, United States

Location

MCB Clinical Research Centers, LLC

Colorado Springs, Colorado, 80910, United States

Location

Lytle and Weiss PLLC

Denver, Colorado, 80209, United States

Location

Connecticut Clinical Research

Cromwell, Connecticut, 06416, United States

Location

Gulfcoast Clinical Research Center

Fort Myers, Florida, 33912, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32256, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

Institute for Advanced Medical Research at Mercer University

Atlanta, Georgia, 30341, United States

Location

Neurotrials Research, Inc.

Atlanta, Georgia, 30342, United States

Location

Northwest ehavioral Research Center

Marietta, Georgia, 30060, United States

Location

Capstone Clinical Research

Libertyville, Illinois, 60048, United States

Location

Phoenix Medical Research, Inc.

Prairie Village, Kansas, 66208, United States

Location

Prairie Health and Wellness

Wichita, Kansas, 67206, United States

Location

McLean Hospital Harvard Medical School

Belmont, Massachusetts, 02478, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

ActivMed Practices and Research, Inc

Methuen, Massachusetts, 01844, United States

Location

Adams Clinical Trials, LLC

Watertown, Massachusetts, 02472, United States

Location

Rocheser Center for Behavioral Medicine

Rochester Hills, Michigan, 48307, United States

Location

Midwest Research Group - St. Charles Psychiatric Associates

Saint Charles, Missouri, 63304, United States

Location

ActivMed Practice and Research, Inc

Portsmouth, New Hampshire, 03801, United States

Location

Center for Emotional Fitness

Cherry Hill, New Jersey, 08002, United States

Location

Bioscience Research, LLC

Mount Kisco, New York, 10549, United States

Location

Manhattan Behavior Medicine

New York, New York, 10036, United States

Location

The Medical Research Network, LLC

New York, New York, 10128, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Radient Research

Akron, Ohio, 44311, United States

Location

Patient Priority Clinical Sites, LLC

Cincinnati, Ohio, 45215, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

Linder Center of Hope

Mason, Ohio, 45040, United States

Location

Oregon Center for Clinical Investigations, Inc.

Portland, Oregon, 97214, United States

Location

Oregon Center for Clinical Investigations, Inc.

Salem, Oregon, 97301, United States

Location

Lehigh Center for Clinical Research

Allentown, Pennsylvania, 18104, United States

Location

Radiant Research

Greer, South Carolina, 29650, United States

Location

Costal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, 38119, United States

Location

Clinical Research Associates, Inc

Nashville, Tennessee, 37203, United States

Location

Donald J. Garcia, MD, PA

Austin, Texas, 78737, United States

Location

Texas Center for Drug Development, Inc

Houston, Texas, 77081, United States

Location

Pillar Clinical Research

Richardson, Texas, 75080, United States

Location

Clinical Trials of Texas, Inc

San Antonio, Texas, 78229, United States

Location

Radiant Research, Inc.

San Antonio, Texas, 78229, United States

Location

Radiant Research, Inc.

Murray, Utah, 84123, United States

Location

Neuropsychiatric Associates

Woodstock, Vermont, 05091, United States

Location

MeSH Terms

Conditions

Binge-Eating Disorder

Interventions

4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydronaphthalen-1-amine; SEP 225289

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Results Point of Contact

• Title: CNS Medical Director
• Organization: Sunovion Pharmaceuticals Inc.

ClinicalTrialDisclosure@sunovion.com

1-866-503-6351

Study Officials

• CNS Medical Director

  Sumitomo Pharma America, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: April 11, 2017
• Study Start: March 31, 2017
• Primary Completion: May 16, 2018
• Study Completion: May 16, 2018
• Last Updated: July 13, 2020
• Results First Posted: July 13, 2020

Record last verified: 2020-06

Locations

US (50)