AzTrials
AzTrials

Binge Eating DisorderPhase 3NCT03107026

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

A Phase 3 study testing dasotraline 4mg and dasotraline 6mg in people with Binge Eating Disorder, run by Sumitomo Pharma America, Inc. at 50 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 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 4mg and dasotraline 6mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
491 participants
Where
50 sitesUnited States
Study dates
31 Mar 2017to 16 May 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 1. Male or female subject between 18-55 years of age, inclusive, at time of informed consent.
  • 2. 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 17Show 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). 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.
  • 3. 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.
  • 4. 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.
  • 5. 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.
  • 8. 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.
  • 9. 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.
  • 10. Subject must be able to comply with study drug administration and adhere to protocol requirements including all study assessments.
  • 11. Subject can read well enough to understand the informed consent form and other subject materials

Who cannot join

  • 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.
Show all 38Show fewer
  • 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.
  • 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 focal or diffuse brain disorder including but not limited to epilepsy, seizures (except childhood febrile seizures),stroke, benign or malignant tumors, or head trauma with loss of consciousness lasting more than 5 minutes; unexplained syncope or other unexplained blackouts (except single incident); or a history of clinically significant repeated head-traumas without loss of consciousness.
  • Subject has had polycystic ovarian syndrome (PCOS) in the previous 12 months, even if no treatment was provided.
  • Subject is female and pregnant or nursing.
  • Subject has had major bariatric surgery, eg, gastric jejunal bypass,Roux-en-Y gastric bypass, sleeve gastrectomy, duodenal switch with biliopancreatic diversion for weight loss at any time.
  • Minor bariatric surgey (eg, lap bands) within 3 years of screening. Note: Surgeries for cosmetic reasons are not exclusionary but should be discussed with the medical monitor.
  • Subject has a history of positive test for either Hepatitis B surface antigen or Hepatitis C antibody, and has 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, serum creatinine > 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 who in the opinion of the Sponsor and Investigator has any other psychiatric or medical condition or disorder or any other psychosocial or work-related issue not previously listed that could interfere with the diagnosis of BED at screening or subsequent evaluations during the course of the study.
  • Subject who may experience or who is currently experiencing significant psychosocial or environmental stressors (eg, loss of employment, loss of housing, financial hardship, divorce) that could impede their ability to adhere to protocol requirements, as judged by the Investigator.
  • Subject is currently participating in 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.
  • Subject has started a new physical training/exercise program for the purpose of managing his or her weight or binge eating within 3 months prior to screening. Note: Subjects participating in a stable physical training/exercise program for longer than 3 months are permitted to enroll.
  • Subject has a history of malignancy within 5 years prior to the Screening visit, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. History of pituitary tumor, whether benign or malignant, is exclusionary.

Trial locations and contacts

50 sites in 1 country.

50 sites in 1 country

United States50 sites

  • Radient Research

    Akron, Ohio, 44311

  • Lehigh Center for Clinical Research

    Allentown, Pennsylvania, 18104

  • Institute for Advanced Medical Research at Mercer University

    Atlanta, Georgia, 30341

  • Neurotrials Research, Inc.

    Atlanta, Georgia, 30342

  • Donald J. Garcia, MD, PA

    Austin, Texas, 78737

  • McLean Hospital Harvard Medical School

    Belmont, Massachusetts, 02478

  • Southern California Research

    Beverly Hills, California, 90210

  • Boston Clinical Trials

    Boston, Massachusetts, 02131

  • Center for Emotional Fitness

    Cherry Hill, New Jersey, 08002

  • Patient Priority Clinical Sites, LLC

    Cincinnati, Ohio, 45215

  • MCB Clinical Research Centers, LLC

    Colorado Springs, Colorado, 80910

  • Connecticut Clinical Research

    Cromwell, Connecticut, 06416

  • Midwest Clinical Research Center

    Dayton, Ohio, 45417

  • Lytle and Weiss PLLC

    Denver, Colorado, 80209

  • Pharmacology Research Institute

    Encino, California, 91316

  • Gulfcoast Clinical Research Center

    Fort Myers, Florida, 33912

  • Collaborative NeuroScience Network, LLC

    Garden Grove, California, 92845

  • Radiant Research

    Greer, South Carolina, 29650

  • Texas Center for Drug Development, Inc

    Houston, Texas, 77081

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida, 32256

  • Capstone Clinical Research

    Libertyville, Illinois, 60048

  • Northwest ehavioral Research Center

    Marietta, Georgia, 30060

  • Linder Center of Hope

    Mason, Ohio, 45040

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee, 38119

  • ActivMed Practices and Research, Inc

    Methuen, Massachusetts, 01844

  • Bioscience Research, LLC

    Mount Kisco, New York, 10549

  • Costal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • Radiant Research, Inc.

    Murray, Utah, 84123

  • Clinical Research Associates, Inc

    Nashville, Tennessee, 37203

  • Manhattan Behavior Medicine

    New York, New York, 10036

  • The Medical Research Network, LLC

    New York, New York, 10128

  • Pharmacology Research Institute

    Newport Beach, California, 92660

  • NoesisPharma, LLC

    Phoenix, Arizona, 85032

  • Oregon Center for Clinical Investigations, Inc.

    Portland, Oregon, 97214

  • ActivMed Practice and Research, Inc

    Portsmouth, New Hampshire, 03801

  • Phoenix Medical Research, Inc.

    Prairie Village, Kansas, 66208

  • Wake Research Associates

    Raleigh, North Carolina, 27612

  • Pillar Clinical Research

    Richardson, Texas, 75080

  • Rocheser Center for Behavioral Medicine

    Rochester Hills, Michigan, 48307

  • Midwest Research Group - St. Charles Psychiatric Associates

    Saint Charles, Missouri, 63304

  • Oregon Center for Clinical Investigations, Inc.

    Salem, Oregon, 97301

  • Clinical Trials of Texas, Inc

    San Antonio, Texas, 78229

  • Radiant Research, Inc.

    San Antonio, Texas, 78229

  • PCSD- Feighner Research

    San Diego, California, 92108

  • Artemis Institute for Clinical Research

    San Marcos, California, 92708

  • Syrentis Clinical Research

    Santa Ana, California, 92705

  • Miami Research Associates

    South Miami, Florida, 33143

  • Adams Clinical Trials, LLC

    Watertown, Massachusetts, 02472

  • Prairie Health and Wellness

    Wichita, Kansas, 67206

  • Neuropsychiatric Associates

    Woodstock, Vermont, 05091

Other trials in United States

About this study

Official title: A 12-week, Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed-dosed, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Dasotraline in Adults With Moderate to Severe Binge Eating Disorder

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

Read the detailed description

This is a randomized, double-blind, parallel-group, multicenter, outpatient study evaluating the efficacy and safety of 2 doses of dasotraline (4 and 6 mg/day) versus placebo over a 12-week treatment period in adults with BED. This study is projected to randomize approximately 480 subjects to 3 treatment groups in a 1:1:1 ratio (4 mg/day dasotraline, 6 mg/day dasotraline, and placebo).

Subjects randomized to placebo will receive placebo for the duration of the treatment period.

Subjects randomized to 4 mg/day dasotraline will receive 4 mg/day for the duration of the treatment period.

Subjects randomized to 6 mg/day dasotraline will be dosed with 4 mg/day dasotraline for the first 2 weeks of the treatment period and will be increased to 6 mg/day at Week 2.

If, in the judgment of the Investigator, the subject does not tolerate the assigned dose, he or she will be discontinued from the study.

The study will consist of 3 periods: Screening (up to 3 weeks), 12-weeks of treatment, and a 3-week study drug withdrawal period. Subjects who complete the 12-week double-blind treatment period in this study may be eligible to enroll and continue treatment for an additional 12 months in an open-label extension study (Study SEP360-322). Subjects who do not enter the extension study will complete the study drug withdrawal period in this study.

Being tested
dasotraline 4mg, dasotraline 6mg, Placebo
Keywords
Binge eating Disorder, dasotraline
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.

  • dasotraline 4mgDrug

    Also called SEP225289

    dasotraline 4mg tablet once daily

  • dasotraline 6mgDrug

    Also called SEP225289

    dasotraline 6mg tablet once daily

  • PlaceboDrug

    Placebo tablet once daily

Study groups in NCT03107026
Study groupRoleWhat they receive
dasotraline 4mgExperimentaldasotraline 4mg once daily
Receives: Drug: dasotraline 4mg
dasotraline 6mgExperimentaldasotraline 6mg once daily
Receives: Drug: dasotraline 6mg
PlaceboPlacebo comparatorPlacebo, once daily
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: baseline and 12 Weeks

Secondary outcomes (13)

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

    Binge-eating Clinical Global Impression-Severity (BE-CGI-S) The BE-CGI-S is a single value, clinician-rated assessment of illness severity, and 7-point scale with range from 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill subjects. A higher score is associated with greater illness severity.

    Measured: baseline and 12 Weeks

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

    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 Week 12/end of treatment [EOT])

    Measured: up to 12 Weeks

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

    Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Y-BOCS-BE total scores range from 0 to 40. Y-BOCS-BE obsessions subscale ranges from 0 to 20. Y-BOCS-BE compulsions subscale ranges from 0 to 20. Higher values of Y-BOCS-BE score and subscale scores represent greater severity of illness

    Measured: baseline and 12 Weeks

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

    Change from baseline in number of binge days per week at Weeks 1, 2, 3, 4, 6, 8, and 10

    Measured: baseline and up to 10 Weeks

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

    Change from baseline in number of binge episodes per week at Weeks 1, 2, 3, 4, 6, 8, 10, and 12

    Measured: baseline and up to 12 Weeks

  6. Change From Baseline in Binge-eating Clinical Global Impression-Severity (BE-CGI-S) Score at Weeks 2, 4, 6, 8, and 10

    Binge-eating Clinical Global Impression-Severity (BE-CGI-S) The BE-CGI-S is a single value, clinician-rated assessment of illness severity, and 7-point scale with range from 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill subjects. A higher score is associated with greater illness severity.

    Measured: baseline and up to 10 Weeks

  7. Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Weeks 2, 4, 6, 8, and 10

    Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Y-BOCS-BE total scores range from 0 to 40. Y-BOCS-BE obsessions subscale ranges from 0 to 20. Y-BOCS-BE compulsions subscale ranges from 0 to 20. Higher values of Y-BOCS-BE score and subscale scores represent greater severity of illness.

    Measured: baseline and up to 10 Weeks

  8. Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Subscale Scores (Obsessions and Compulsions) at Weeks 2, 4, 6, 8, 10, and 12

    Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Y-BOCS-BE total scores range from 0 to 40. Y-BOCS-BE obsessions subscale ranges from 0 to 20. Y-BOCS-BE compulsions subscale ranges from 0 to 20. Higher values of Y-BOCS-BE score and subscale scores represent greater severity of illness.

    Measured: baseline and up to 12 weeks

  9. Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Subscale Scores (School/Work Disability, Social Life Disability, and Family Life Disability) at Weeks 6 and 12

    Sheehan Disability Scale (SDS) total and subscale scores The Sheehan Disability Scale (SDS) 3 subscales (work/school, social life, home life) are rated on the following scale: 0 = not at all; 1-3 = mildly; 4-6 = moderately; 7-9 =markedly; 10 = extremely. The 3 items can be combined into a single global measure of impairment (SDS total score) that ranges from 0 (unimpaired) to 30 (highly impaired). A higher subscale score and total score are associated with greater illness severity

    Measured: baseline and 6 Weeks and 12 Weeks

  10. Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 12

    Montgomery-Asberg Depression Rating Scale (MADRS) total score The MADRS total score ranges from 0 to 60, with higher scores indicating increased depressive symptoms

    Measured: baseline and 12 Weeks

  11. Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Week 12

    Hamilton Anxiety Rating Scale (HAM-A) total score HAM-A total score ranges from 0 to 56. A higher score is associated with a greater degree of anxiety.

    Measured: baseline and 12 Weeks

  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 ≥ 75% reduction in the number of binge eating episodes from Baseline at Week 12

    Measured: 12 Weeks

  13. Change From Baseline in Eating Disorder Examination Questionnaire (EDE-Q) Modified Including EDE-Q7 Global Score and 3 Subscale Scores (Dietary Restraint, Shape/Weight Overvaluation, and Body Dissatisfaction) at Week 12

    Eating Disorder Examination Questionnaire (EDE-Q) Modified global and subscale scores 4 subscale scores (Restraint, Eating Concern, Shape Concern, and Weight Concern) range from 0- 6, where 0 represents absence of the feature and 6 represents an extreme degree. An EDE-Q global score is calculated as average of 4 EDE-Q subscale scores.

    Measured: baseline and 2 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2017
  2. Study start31 Mar 2017
  3. Primary completion16 May 2018
  4. Study completion16 May 2018

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
491 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03107026
Sponsor's protocol ID
SEP360-321
Status last verified
Jun 2020
First submitted
17 Mar 2017
Last updated
13 Jul 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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 41697570

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing dasotraline 4mg and dasotraline 6mg in people with Binge Eating Disorder, run by Sumitomo Pharma America, Inc. at 50 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 17 inclusion and 38 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 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 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 phase mean?

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?

Yes. Results are posted in the registry (first posted 13 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (time frame: baseline and 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 NCT03107026, which also lists 1 linked publication.

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 13 Jul 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in