Trial · NCT03107026

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, Phase 3, Completed, Sumitomo Pharma America, Inc.; results first posted 2020-07-13

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. 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. Trials, record NCT03107026. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03107026

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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
NCT number: NCT03107026
Status: Completed
Phases: Phase 3
Enrollment: 491 participants, actual
Lead sponsor: Sumitomo Pharma America, Inc.
Conditions: Binge Eating Disorder
Interventions: dasotraline 4mg, dasotraline 6mg, Placebo
First posted: 2017-04-11
Last updated: 2020-07-13
Results first posted: 2020-07-13

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Number of Binge Days	baseline and 12 Weeks	Change from baseline in number of binge days (defined as days during which at least 1 binge episode occurs) per week at Week 12
Secondary	Change From Baseline in Binge Eating Clinical Global Impression-Severity( BE-CGI-S )Score	baseline and 12 Weeks	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.
Secondary	Percent of Subjects With a 4-week Cessation From Binge Eating	up to 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 Week 12/end of treatment \[EOT\])
Secondary	Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score	baseline and 12 Weeks	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
Secondary	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 days per week at Weeks 1, 2, 3, 4, 6, 8, and 10
Secondary	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	Change from baseline in number of binge episodes per week at Weeks 1, 2, 3, 4, 6, 8, 10, and 12
Secondary	Change From Baseline in Binge-eating Clinical Global Impression-Severity (BE-CGI-S) Score at Weeks 2, 4, 6, 8, and 10	baseline and up to 10 Weeks	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.
Secondary	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	baseline and up to 10 Weeks	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.
Secondary	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	baseline and up to 12 weeks	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.
Secondary	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	baseline and 6 Weeks and 12 Weeks	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

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Number of Binge Days	baseline and 12 Weeks	ITT	binge days/week	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Binge Eating Clinical Global Impression-Severity( BE-CGI-S )Score	baseline and 12 Weeks	ITT	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percent of Subjects With a 4-week Cessation From Binge Eating	up to 12 Weeks	ITT	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score	baseline and 12 Weeks	ITT	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	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	ITT	binge days/week	LEAST_SQUARES_MEAN
SECONDARY	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	ITT	binge episodes	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Binge-eating Clinical Global Impression-Severity (BE-CGI-S) Score at Weeks 2, 4, 6, 8, and 10	baseline and up to 10 Weeks	ITT	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	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	baseline and up to 10 Weeks	ITT	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	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	baseline and up to 12 weeks	ITT	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	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	baseline and 6 Weeks and 12 Weeks	ITT	units on a scale	LEAST_SQUARES_MEAN

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group168

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Number of Binge Days	Placebo	-2.92	Standard Error 0.134	binge days/week
Change From Baseline in Number of Binge Days	Dasotraline 4mg	-3.21	Standard Error 0.135	binge days/week
Change From Baseline in Number of Binge Days	Dasotraline 6mg	-3.47	Standard Error 0.140	binge days/week
Change From Baseline in Binge Eating Clinical Global Impression-Severity( BE-CGI-S )Score	Placebo	-1.77	Standard Error 0.114	units on a scale
Change From Baseline in Binge Eating Clinical Global Impression-Severity( BE-CGI-S )Score	Dasotraline 4mg	-2.13	Standard Error 0.117	units on a scale
Change From Baseline in Binge Eating Clinical Global Impression-Severity( BE-CGI-S )Score	Dasotraline 6mg	-2.27	Standard Error 0.121	units on a scale
Percent of Subjects With a 4-week Cessation From Binge Eating	Placebo	49		Participants
Percent of Subjects With a 4-week Cessation From Binge Eating	Dasotraline 4mg	54		Participants
Percent of Subjects With a 4-week Cessation From Binge Eating	Dasotraline 6mg	55		Participants
Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score	Placebo	-11.83	Standard Error 0.670	units on a scale

1 to 10 of 168Source ClinicalTrials.gov

See all 168 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	163
Overall Study	STARTED	Dasotraline 4mg	161
Overall Study	STARTED	Dasotraline 6mg	162
Overall Study	COMPLETED	Placebo	131
Overall Study	COMPLETED	Dasotraline 4mg	123
Overall Study	COMPLETED	Dasotraline 6mg	106
Overall Study	NOT COMPLETED	Placebo	32
Overall Study	NOT COMPLETED	Dasotraline 4mg	38
Overall Study	NOT COMPLETED	Dasotraline 6mg	56

Source ClinicalTrials.gov

Adverse events48

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Constipation	Gastrointestinal disorders	Placebo	3	163	4
other	Constipation	Gastrointestinal disorders	Dasotraline 4mg	6	161	6
other	Constipation	Gastrointestinal disorders	Dasotraline 6mg	11	162	11
other	Dry mouth	Gastrointestinal disorders	Placebo	11	163	11
other	Dry mouth	Gastrointestinal disorders	Dasotraline 4mg	34	161	34
other	Dry mouth	Gastrointestinal disorders	Dasotraline 6mg	43	162	45
other	Nausea	Gastrointestinal disorders	Placebo	9	163	10
other	Nausea	Gastrointestinal disorders	Dasotraline 4mg	19	161	22
other	Nausea	Gastrointestinal disorders	Dasotraline 6mg	21	162	25
other	Upper respiratory tract infection	Infections and infestations	Placebo	23	163	25

1 to 10 of 48Source ClinicalTrials.gov

See all 48 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	163
Total, all-cause mortality	Dasotraline 4mg	0	161
Total, all-cause mortality	Dasotraline 6mg	0	162
Total, other adverse events	Placebo	70	163
Total, other adverse events	Dasotraline 4mg	105	161
Total, other adverse events	Dasotraline 6mg	113	162
Total, serious adverse events	Placebo	1	163
Total, serious adverse events	Dasotraline 4mg	3	161
Total, serious adverse events	Dasotraline 6mg	1	162

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
41697570	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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