NCT02684279

Dasotraline Binge Eating Disorder Extension Study

Completed Phase 3 Results posted Last updated 12 August 2020

What this trial tests

Phase 3 trial testing Dasotraline in Binge Eating Disorder in 533 participants. Completed in 24 June 2019.

Timeline

29 February 2016

Primary endpoint
24 June 2019

24 June 2019

Quick facts

Lead sponsor	Sumitomo Pharma America, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	533
Start date	29 February 2016
Primary completion	24 June 2019
Estimated completion	24 June 2019
Sites	57 locations across United States

Drugs / interventions tested

• Dasotraline — full drug profile →

Conditions studied

• Binge Eating Disorder — all drugs for Binge Eating Disorder →

Sponsor

Sumitomo Pharma America, Inc. — full company profile →

Who can join

Adults 18 to 56, any sex, with Binge Eating Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Frequency and Severity of Suicidal Ideation Using the Columbia-suicide Severity Rating Scale (C-SSRS) Primary · Baseline to Week 52

Columbia-suicide severity rating scale (C-SSRS) Severity of suicidal ideation is rated on a 6-point scale from 0='No ideation present' to 5='Active ideation with plan and intent'. A score of 4 or 5 on this scale indicates serious suicidal ideation. Suicidal behavior is collected as presence/absence of actual attempts, non-suicidal self-injurious behavior, interrupted attempts, aborted attempts, preparatory acts or behavior, and any suicidal behavior

Group	Value	95% CI
Dasotraline	515
Dasotraline	7
Dasotraline	3
Dasotraline	1

Frequency and Severity of Suicidal Behavior Using the C-SSRS Primary · Baseline to Week 52

Columbia-suicide severity rating scale (C-SSRS) Severity of suicidal ideation is rated on a 6-point scale from 0='No ideation present' to 5='Active ideation with plan and intent'. A score of 4 or 5 on this scale indicates serious suicidal ideation. Suicidal behavior is collected as presence/absence of actual attempts, non-suicidal self-injurious behavior, interrupted attempts, aborted attempts, preparatory acts or behavior, and any suicidal behavior

Preparatory acts or behavior

Group	Value	95% CI
Dasotraline	1

Aborted attempt

Group	Value	95% CI
Dasotraline	0

Interrupted attempt

Group	Value	95% CI
Dasotraline	0

Actual attempt

Group	Value	95% CI
Dasotraline	1

Completed suicide

Group	Value	95% CI
Dasotraline	0

Change in Body Weight Secondary · Baseline, Week 52

Change in body weight

Change from DB Baseline Week 52 Endpoint

Group	Value	95% CI
Dasotraline	-4.65	-5.36 – -3.93

Change from OL Baseline Week 52 Endpoint

Group	Value	95% CI
Dasotraline	-2.13	-2.77 – -1.49

Percent Change in Body Weight (kg) Secondary · Baseline, Week 52

Percent change in body weight (kg)

% Change from DB Baseline Week 52 Endpoint

Group	Value	95% CI
Dasotraline	-4.65	-5.35 – -3.95

% Change from OL Baseline Week 52 Endpoint

Group	Value	95% CI
Dasotraline	-2.07	-2.71 – -1.43

Change in Body Mass Index Secondary · Baseline, Week 52

Change in Body Mass Index

Change from DB Baseline Week 52 Endpoint

Group	Value	95% CI
Dasotraline	-1.64	-1.89 – -1.39

Change from OL Baseline Week 52 Endpoint

Group	Value	95% CI
Dasotraline	-0.75	-0.97 – -0.53

Percent Change in Body Mass Index (kg/m^2) Secondary · Baseline, Week 52

Percent change in Body Mass Index (kg/m\^2)

% Change from DB Baseline Week 52 Endpoint

Group	Value	95% CI
Dasotraline	-4.65	-5.35 – -3.95

% Change from OL Baseline Week 52 Endpoint

Group	Value	95% CI
Dasotraline	-2.07	-2.71 – -1.43

Change in Fasting Lipid Panel, Triglyceride's Secondary · Baseline, Week 52

Change in fasting lipid panel, Triglyceride's

Change from DB Baseline Week 52 Endpoint

Group	Value	95% CI
Dasotraline	-11.9	-17.5 – -6.3

Change from OL Baseline Week 52 Endpoint

Group	Value	95% CI
Dasotraline	-5.3	-10.4 – -0.3

Change in Fasting Lipid Panel , Total Cholesterol Secondary · Baseline, Week 52

Change in fasting lipid panel , total cholesterol

Change from DB Baseline Week 52 Endpoint

Group	Value	95% CI
Dasotraline	-7.0	-9.3 – -4.8

Change from OL Baseline Week 52 Endpoint

Group	Value	95% CI
Dasotraline	-3.5	-5.6 – -1.4

Change in Fasting Lipid Panel , High-density Lipoprotein [HDL] Cholesterol, Secondary · Baseline, Week 52

Change in fasting lipid panel, high-density lipoprotein \[HDL\] cholesterol,

Change from DB Baseline Week 52 Endpoint

Group	Value	95% CI
Dasotraline	-1.1	-2.0 – -0.2

Change from OL Baseline Week 52 Endpoint

Group	Value	95% CI
Dasotraline	1.1	0.2 – 1.9

Change in Fasting Lipid Panel, Low-density Lipoprotein [LDL] Cholesterol) Secondary · Baseline, Week 52

Change in fasting lipid panel, low-density lipoprotein \[LDL\] cholesterol)

Change from DB Baseline Week 52 Endpoint

Group	Value	95% CI
Dasotraline	-3.6	-5.5 – -1.6

Change from OL Baseline Week 52 Endpoint

Group	Value	95% CI
Dasotraline	-3.4	-5.2 – -1.5

Change in Hemoglobin A1c Levels Secondary · Baseline, Week 52

Change in hemoglobin A1c levels

Change from DB Baseline Week 52 Endpoint

Group	Value	95% CI
Dasotraline	0.00	-0.02 – 0.02

Change from OL Baseline Week 52 Endpoint

Group	Value	95% CI
Dasotraline	0.00	-0.02 – 0.02

Change in Fasting Glucose Levels Secondary · Baseline, Week 52

Change in fasting glucose levels

Change from DB Baseline Week 52 Endpoint

Group	Value	95% CI
Dasotraline	2.2	0.9 – 3.5

Change from OL Baseline Week 52 Endpoint

Group	Value	95% CI
Dasotraline	1.7	0.3 – 3.1

Adverse events — posted to ClinicalTrials.gov

Time frame: An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dasotraline

Serious: 21/528 (4%)

Deaths: 0/528

Serious adverse events (25 terms)

Reaction	System	Dasotraline
Anaemia	Blood and lymphatic system disorders	—
Iron deficiency anaemia	Blood and lymphatic system disorders	—
Abdominal adhesions	Gastrointestinal disorders	—
Colitis	Gastrointestinal disorders	—
Rectal haemorrhage	Gastrointestinal disorders	—
Cholecystitis	Hepatobiliary disorders	—
Cholelithiasis	Hepatobiliary disorders	—
Hypersensitivity	Immune system disorders	—
Cellulitis	Infections and infestations	—
Localised infection	Infections and infestations	—
Laceration	Injury, poisoning and procedural complications	—
Lumbar vertebral fracture	Injury, poisoning and procedural complications	—
Post procedural inflammation	Injury, poisoning and procedural complications	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Hemiplegic migraine	Nervous system disorders	—
Partial seizures	Nervous system disorders	—
Seizure	Nervous system disorders	—
Panic attack	Psychiatric disorders	—
Paranoia	Psychiatric disorders	—
Psychotic disorder	Psychiatric disorders	—
Substance-induced mood disorder	Psychiatric disorders	—
Suicide attempt	Psychiatric disorders	—
Nephrolithiasis	Renal and urinary disorders	—
Menorrhagia	Reproductive system and breast disorders	—

Other adverse events (9 terms — click to expand)

Reaction	System	Dasotraline
Insomnia	Psychiatric disorders	—
Weight decreased	Investigations	—
Dry mouth	Gastrointestinal disorders	—
Anxiety	Psychiatric disorders	—
Headache	Nervous system disorders	—
Upper respiratory tract infection	Infections and infestations	—
Nasopharyngitis	Infections and infestations	—
Nausea	Gastrointestinal disorders	—
Irritability	Psychiatric disorders	—

Most-reported serious reactions: Anaemia, Iron deficiency anaemia, Abdominal adhesions, Colitis, Rectal haemorrhage, Cholecystitis, Cholelithiasis, Hypersensitivity.

Data from ClinicalTrials.gov NCT02684279 adverse events section.

Sponsor's own description

Binge Eating Disorder Extension Study.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Converging vulnerability factors for compulsive food and drug use.
   Serafine KM, O'Dell LE, Zorrilla EP. · · 2021 · cited 17× · PMID 33862029 · DOI 10.1016/j.neuropharm.2021.108556
2. Approved and Pipeline Pharmacological Interventions for Eating Disorders (2010-2025): 15 Years of Progress (or Lack Thereof).
   Hirsch D, Reed J, Naqvi A, Ngor A, et al · · 2026 · PMID 41313392 · DOI 10.1007/s40263-025-01248-7