Trial Outcomes & Findings for 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 NCT03107026)

Last Updated: 2020-07-13

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

491 participants

Primary outcome timeframe

baseline and 12 Weeks

Results posted on

2020-07-13

Participant Flow

A total 491 subjects were randomized in this study. Five subjects were randomized but never received any dose of study medication.

Participant milestones

Participant milestones
Measure	Placebo Placebo, once daily	Dasotraline 4mg Dasotraline 4mg once daily	Dasotraline 6mg Dasotraline 6mg once daily
Overall Study STARTED	163	161	162
Overall Study COMPLETED	131	123	106
Overall Study NOT COMPLETED	32	38	56

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo, once daily	Dasotraline 4mg Dasotraline 4mg once daily	Dasotraline 6mg Dasotraline 6mg once daily
Overall Study Adverse Event	2	14	23
Overall Study Lost to Follow-up	12	12	13
Overall Study Protocol Violation	1	2	0
Overall Study Pregnancy	1	0	0
Overall Study Withdrawal by Subject	13	5	17
Overall Study non compliance with study visits	1	2	0
Overall Study non-compliance with study drug	2	2	3
Overall Study Physician Decision	0	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=163 Participants Placebo, once daily	Dasotraline 4mg n=161 Participants Dasotraline 4mg once daily	Dasotraline 6mg n=162 Participants Dasotraline 6mg once daily	Total n=486 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	162 Participants n=5 Participants	160 Participants n=7 Participants	160 Participants n=5 Participants	482 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	37.2 Years STANDARD_DEVIATION 10.26 • n=5 Participants	36.9 Years STANDARD_DEVIATION 9.55 • n=7 Participants	38.9 Years STANDARD_DEVIATION 9.7 • n=5 Participants	37.7 Years STANDARD_DEVIATION 9.86 • n=4 Participants
Sex: Female, Male Female	137 Participants n=5 Participants	138 Participants n=7 Participants	133 Participants n=5 Participants	408 Participants n=4 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	23 Participants n=7 Participants	29 Participants n=5 Participants	78 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	28 Participants n=5 Participants	31 Participants n=7 Participants	26 Participants n=5 Participants	85 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	135 Participants n=5 Participants	130 Participants n=7 Participants	136 Participants n=5 Participants	401 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	12 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	29 Participants n=5 Participants	25 Participants n=7 Participants	32 Participants n=5 Participants	86 Participants n=4 Participants
Race (NIH/OMB) White	131 Participants n=5 Participants	119 Participants n=7 Participants	121 Participants n=5 Participants	371 Participants n=4 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	8 Participants n=7 Participants	3 Participants n=5 Participants	13 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Height (cm)	167.4 cm STANDARD_DEVIATION 8.64 • n=5 Participants	166.8 cm STANDARD_DEVIATION 8.33 • n=7 Participants	167.3 cm STANDARD_DEVIATION 8.22 • n=5 Participants	167.2 cm STANDARD_DEVIATION 8.38 • n=4 Participants
Weight (kg)	96.9 kg STANDARD_DEVIATION 20.79 • n=5 Participants	96.9 kg STANDARD_DEVIATION 19.69 • n=7 Participants	96.1 kg STANDARD_DEVIATION 17.97 • n=5 Participants	96.6 kg STANDARD_DEVIATION 19.48 • n=4 Participants
BMI (kg/m^2)	34.46 kg/m^2 STANDARD_DEVIATION 6.283 • n=5 Participants	34.76 kg/m^2 STANDARD_DEVIATION 6.073 • n=7 Participants	34.27 kg/m^2 STANDARD_DEVIATION 5.743 • n=5 Participants	34.5 kg/m^2 STANDARD_DEVIATION 6.028 • n=4 Participants
Number of Binge Eating Days per Week at Baseline	4.26 binge eating days/week STANDARD_DEVIATION 0.994 • n=5 Participants	4.22 binge eating days/week STANDARD_DEVIATION 1.115 • n=7 Participants	4.19 binge eating days/week STANDARD_DEVIATION 1.069 • n=5 Participants	4.22 binge eating days/week STANDARD_DEVIATION 1.058 • n=4 Participants
Binge-eating Clinical Global Impression-Severity (BE-CGI-S) score at Baseline	4.4 units on a scale STANDARD_DEVIATION 0.51 • n=5 Participants	4.5 units on a scale STANDARD_DEVIATION 0.51 • n=7 Participants	4.4 units on a scale STANDARD_DEVIATION 0.51 • n=5 Participants	4.4 units on a scale STANDARD_DEVIATION 0.51 • n=4 Participants
Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) total score at Baseline	21.9 units on a scale STANDARD_DEVIATION 3.66 • n=5 Participants	21.6 units on a scale STANDARD_DEVIATION 3.71 • n=7 Participants	21.6 units on a scale STANDARD_DEVIATION 4.29 • n=5 Participants	21.7 units on a scale STANDARD_DEVIATION 3.89 • n=4 Participants
BMI category Underweight/Normal (<25)	12 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	29 Participants n=4 Participants
BMI category Overweight (25 to <30)	28 Participants n=5 Participants	32 Participants n=7 Participants	30 Participants n=5 Participants	90 Participants n=4 Participants
BMI category Obesity Class I (30 to <35)	43 Participants n=5 Participants	41 Participants n=7 Participants	48 Participants n=5 Participants	132 Participants n=4 Participants
BMI category Obesity Class II (35 to <40)	46 Participants n=5 Participants	46 Participants n=7 Participants	45 Participants n=5 Participants	137 Participants n=4 Participants
BMI category Obesity Class III (>=40)	34 Participants n=5 Participants	33 Participants n=7 Participants	31 Participants n=5 Participants	98 Participants n=4 Participants
Number of Binge Eating Episodes per Week at Baseline	5.59 Binge eating episodes/week STANDARD_DEVIATION 2.803 • n=5 Participants	5.42 Binge eating episodes/week STANDARD_DEVIATION 3.546 • n=7 Participants	5.35 Binge eating episodes/week STANDARD_DEVIATION 2.992 • n=5 Participants	5.45 Binge eating episodes/week STANDARD_DEVIATION 3.123 • n=4 Participants

PRIMARY outcome

Timeframe: baseline and 12 Weeks

Population: ITT

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

Outcome measures

Outcome measures
Measure	Placebo n=162 Participants Placebo, once daily	Dasotraline 4mg n=161 Participants Dasotraline 4mg once daily	Dasotraline 6mg n=162 Participants Dasotraline 6mg once daily
Change From Baseline in Number of Binge Days	-2.92 binge days/week Standard Error 0.134	-3.21 binge days/week Standard Error 0.135	-3.47 binge days/week Standard Error 0.140

SECONDARY outcome

Timeframe: baseline and 12 Weeks

Population: ITT

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.

Outcome measures

Outcome measures
Measure	Placebo n=162 Participants Placebo, once daily	Dasotraline 4mg n=161 Participants Dasotraline 4mg once daily	Dasotraline 6mg n=162 Participants Dasotraline 6mg once daily
Change From Baseline in Binge Eating Clinical Global Impression-Severity( BE-CGI-S )Score	-1.77 units on a scale Standard Error 0.114	-2.13 units on a scale Standard Error 0.117	-2.27 units on a scale Standard Error 0.121

SECONDARY outcome

Timeframe: up to 12 Weeks

Population: ITT

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 \[EOT\])

Outcome measures

Outcome measures
Measure	Placebo n=162 Participants Placebo, once daily	Dasotraline 4mg n=161 Participants Dasotraline 4mg once daily	Dasotraline 6mg n=162 Participants Dasotraline 6mg once daily
Percent of Subjects With a 4-week Cessation From Binge Eating	49 Participants	54 Participants	55 Participants

SECONDARY outcome

Timeframe: baseline and 12 Weeks

Population: ITT

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

Outcome measures

Outcome measures
Measure	Placebo n=162 Participants Placebo, once daily	Dasotraline 4mg n=161 Participants Dasotraline 4mg once daily	Dasotraline 6mg n=162 Participants Dasotraline 6mg once daily
Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score	-11.83 units on a scale Standard Error 0.670	-14.13 units on a scale Standard Error 0.680	-15.23 units on a scale Standard Error 0.703

SECONDARY outcome

Timeframe: baseline and up to 10 Weeks

Population: ITT

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

Outcome measures

Outcome measures
Measure	Placebo n=162 Participants Placebo, once daily	Dasotraline 4mg n=161 Participants Dasotraline 4mg once daily	Dasotraline 6mg n=162 Participants Dasotraline 6mg once daily
Change From Baseline in Number of Binge Days Per Week at Weeks 1, 2, 3, 4, 6, 8, and 10 Week 4	-2.27 binge days/week Standard Error 0.143	-2.85 binge days/week Standard Error 0.144	-2.98 binge days/week Standard Error 0.145
Change From Baseline in Number of Binge Days Per Week at Weeks 1, 2, 3, 4, 6, 8, and 10 Week 6	-2.61 binge days/week Standard Error 0.126	-2.97 binge days/week Standard Error 0.127	-3.24 binge days/week Standard Error 0.130
Change From Baseline in Number of Binge Days Per Week at Weeks 1, 2, 3, 4, 6, 8, and 10 Week 8	-2.80 binge days/week Standard Error 0.127	-3.15 binge days/week Standard Error 0.127	-3.31 binge days/week Standard Error 0.132
Change From Baseline in Number of Binge Days Per Week at Weeks 1, 2, 3, 4, 6, 8, and 10 Week 10	-2.87 binge days/week Standard Error 0.128	-3.12 binge days/week Standard Error 0.129	-3.31 binge days/week Standard Error 0.134
Change From Baseline in Number of Binge Days Per Week at Weeks 1, 2, 3, 4, 6, 8, and 10 Week 1	-1.16 binge days/week Standard Error 0.137	-1.82 binge days/week Standard Error 0.137	-1.51 binge days/week Standard Error 0.136
Change From Baseline in Number of Binge Days Per Week at Weeks 1, 2, 3, 4, 6, 8, and 10 Week 2	-1.74 binge days/week Standard Error 0.137	-2.36 binge days/week Standard Error 0.138	-2.27 binge days/week Standard Error 0.136
Change From Baseline in Number of Binge Days Per Week at Weeks 1, 2, 3, 4, 6, 8, and 10 Week 3	-2.23 binge days/week Standard Error 0.135	-2.74 binge days/week Standard Error 0.136	-2.70 binge days/week Standard Error 0.135

SECONDARY outcome

Timeframe: baseline and up to 12 Weeks

Population: ITT

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

Outcome measures

Outcome measures
Measure	Placebo n=162 Participants Placebo, once daily	Dasotraline 4mg n=161 Participants Dasotraline 4mg once daily	Dasotraline 6mg n=162 Participants Dasotraline 6mg once daily
Change From Baseline in Number of Binge Episodes Per Week at Weeks 1, 2, 3, 4, 6, 8, 10, and 12 Week 8	-3.64 binge episodes Standard Error 0.216	-4.20 binge episodes Standard Error 0.218	-4.19 binge episodes Standard Error 0.223
Change From Baseline in Number of Binge Episodes Per Week at Weeks 1, 2, 3, 4, 6, 8, 10, and 12 Week 10	-3.67 binge episodes Standard Error 0.213	-4.17 binge episodes Standard Error 0.215	-4.25 binge episodes Standard Error 0.221
Change From Baseline in Number of Binge Episodes Per Week at Weeks 1, 2, 3, 4, 6, 8, 10, and 12 Week 1	-1.53 binge episodes Standard Error 0.230	-2.43 binge episodes Standard Error 0.231	-2.21 binge episodes Standard Error 0.230
Change From Baseline in Number of Binge Episodes Per Week at Weeks 1, 2, 3, 4, 6, 8, 10, and 12 Week 2	-2.48 binge episodes Standard Error 0.235	-3.20 binge episodes Standard Error 0.237	-2.88 binge episodes Standard Error 0.234
Change From Baseline in Number of Binge Episodes Per Week at Weeks 1, 2, 3, 4, 6, 8, 10, and 12 Week 3	-3.06 binge episodes Standard Error 0.226	-3.69 binge episodes Standard Error 0.228	-3.46 binge episodes Standard Error 0.226
Change From Baseline in Number of Binge Episodes Per Week at Weeks 1, 2, 3, 4, 6, 8, 10, and 12 Week 4	-2.95 binge episodes Standard Error 0.254	-3.72 binge episodes Standard Error 0.256	-3.77 binge episodes Standard Error 0.257
Change From Baseline in Number of Binge Episodes Per Week at Weeks 1, 2, 3, 4, 6, 8, 10, and 12 Week 6	-3.43 binge episodes Standard Error 0.231	-3.90 binge episodes Standard Error 0.234	-4.06 binge episodes Standard Error 0.236
Change From Baseline in Number of Binge Episodes Per Week at Weeks 1, 2, 3, 4, 6, 8, 10, and 12 week 12	-3.70 binge episodes Standard Error 0.227	-4.32 binge episodes Standard Error 0.230	-4.38 binge episodes Standard Error 0.237

SECONDARY outcome

Timeframe: baseline and up to 10 Weeks

Population: ITT

Outcome measures

Outcome measures
Measure	Placebo n=162 Participants Placebo, once daily	Dasotraline 4mg n=161 Participants Dasotraline 4mg once daily	Dasotraline 6mg n=162 Participants Dasotraline 6mg once daily
Change From Baseline in Binge-eating Clinical Global Impression-Severity (BE-CGI-S) Score at Weeks 2, 4, 6, 8, and 10 Week 6	-1.37 units on a scale Standard Error 0.105	-1.83 units on a scale Standard Error 0.107	-1.90 units on a scale Standard Error 0.108
Change From Baseline in Binge-eating Clinical Global Impression-Severity (BE-CGI-S) Score at Weeks 2, 4, 6, 8, and 10 Week 2	-0.82 units on a scale Standard Error 0.090	-1.37 units on a scale Standard Error 0.091	-1.20 units on a scale Standard Error 0.090
Change From Baseline in Binge-eating Clinical Global Impression-Severity (BE-CGI-S) Score at Weeks 2, 4, 6, 8, and 10 Week 4	-1.21 units on a scale Standard Error 0.102	-1.89 units on a scale Standard Error 0.104	-1.79 units on a scale Standard Error 0.102
Change From Baseline in Binge-eating Clinical Global Impression-Severity (BE-CGI-S) Score at Weeks 2, 4, 6, 8, and 10 Week 8	-1.55 units on a scale Standard Error 0.108	-1.91 units on a scale Standard Error 0.110	-2.04 units on a scale Standard Error 0.113
Change From Baseline in Binge-eating Clinical Global Impression-Severity (BE-CGI-S) Score at Weeks 2, 4, 6, 8, and 10 Week 10	-1.59 units on a scale Standard Error 0.112	-1.95 units on a scale Standard Error 0.115	-2.07 units on a scale Standard Error 0.119

SECONDARY outcome

Timeframe: baseline and up to 10 Weeks

Population: ITT

Outcome measures

Outcome measures
Measure	Placebo n=162 Participants Placebo, once daily	Dasotraline 4mg n=161 Participants Dasotraline 4mg once daily	Dasotraline 6mg n=162 Participants Dasotraline 6mg once daily
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 Week 2	-6.49 units on a scale Standard Error 0.576	-10.32 units on a scale Standard Error 0.583	-9.21 units on a scale Standard Error 0.577
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 Week 4	-9.30 units on a scale Standard Error 0.623	-13.15 units on a scale Standard Error 0.631	-12.77 units on a scale Standard Error 0.627
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 Week 6	-9.74 units on a scale Standard Error 0.645	-12.50 units on a scale Standard Error 0.653	-13.65 units on a scale Standard Error 0.663
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 Week 8	-10.99 units on a scale Standard Error 0.654	-13.55 units on a scale Standard Error 0.661	-14.25 units on a scale Standard Error 0.681
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 Week 10	-10.81 units on a scale Standard Error 0.658	-13.54 units on a scale Standard Error 0.668	-14.21 units on a scale Standard Error 0.690

SECONDARY outcome

Timeframe: baseline and up to 12 weeks

Population: ITT

Outcome measures

Outcome measures
Measure	Placebo n=162 Participants Placebo, once daily	Dasotraline 4mg n=161 Participants Dasotraline 4mg once daily	Dasotraline 6mg n=162 Participants Dasotraline 6mg once daily
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 Compulsions Subscale Score Week 12	-6.24 units on a scale Standard Error 0.352	-7.34 units on a scale Standard Error 0.357	-7.78 units on a scale Standard Error 0.370
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 Obsessions Subscale Score Week 2	-3.14 units on a scale Standard Error 0.297	-4.84 units on a scale Standard Error 0.301	-4.37 units on a scale Standard Error 0.297
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 Obsessions Subscale Score Week 4	-4.30 units on a scale Standard Error 0.315	-6.32 units on a scale Standard Error 0.319	-6.29 units on a scale Standard Error 0.317
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 Obsessions Subscale Score Week 6	-4.65 units on a scale Standard Error 0.326	-6.12 units on a scale Standard Error 0.330	-6.70 units on a scale Standard Error 0.336
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 Obsessions Subscale Score Week 8	-5.20 units on a scale Standard Error 0.337	-6.48 units on a scale Standard Error 0.341	-7.00 units on a scale Standard Error 0.354
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 Obsessions Subscale Score Week 10	-4.94 units on a scale Standard Error 0.335	-6.49 units on a scale Standard Error 0.340	-6.88 units on a scale Standard Error 0.353
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 Compulsions Subscale Score Week 8	-5.77 units on a scale Standard Error 0.343	-7.03 units on a scale Standard Error 0.347	-7.22 units on a scale Standard Error 0.359
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 Compulsions Subscale Score Week 10	-5.85 units on a scale Standard Error 0.344	-7.00 units on a scale Standard Error 0.349	-7.30 units on a scale Standard Error 0.361
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 Obsessions Subscale Score Week 12	-5.56 units on a scale Standard Error 0.339	-6.73 units on a scale Standard Error 0.344	-7.43 units on a scale Standard Error 0.356
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 Compulsions Subscale Score Week 2	-3.32 units on a scale Standard Error 0.303	-5.45 units on a scale Standard Error 0.307	-4.83 units on a scale Standard Error 0.304
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 Compulsions Subscale Score Week 4	-4.98 units on a scale Standard Error 0.330	-6.80 units on a scale Standard Error 0.334	-6.44 units on a scale Standard Error 0.333
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 Compulsions Subscale Score Week 6	-5.08 units on a scale Standard Error 0.337	-6.34 units on a scale Standard Error 0.341	-6.91 units on a scale Standard Error 0.348

SECONDARY outcome

Timeframe: baseline and 6 Weeks and 12 Weeks

Population: ITT

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

Outcome measures

Outcome measures
Measure	Placebo n=162 Participants Placebo, once daily	Dasotraline 4mg n=161 Participants Dasotraline 4mg once daily	Dasotraline 6mg n=162 Participants Dasotraline 6mg once daily
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 SDS Family Life/Home Responsibilities Week 6	-2.04 units on a scale Standard Error 0.188	-2.59 units on a scale Standard Error 0.188	-2.40 units on a scale Standard Error 0.192
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 SDS Total Score Week 12	-6.14 units on a scale Standard Error 0.547	-8.56 units on a scale Standard Error 0.551	-8.19 units on a scale Standard Error 0.580
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 SDS Work/School Week 6	-1.20 units on a scale Standard Error 0.185	-1.81 units on a scale Standard Error 0.189	-1.57 units on a scale Standard Error 0.191
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 SDS Work/School Week 12	-1.33 units on a scale Standard Error 0.189	-1.93 units on a scale Standard Error 0.190	-1.84 units on a scale Standard Error 0.201
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 SDS Social Life Week 6	-2.26 units on a scale Standard Error 0.199	-3.06 units on a scale Standard Error 0.199	-2.82 units on a scale Standard Error 0.203
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 SDS Social Life Week 12	-2.38 units on a scale Standard Error 0.195	-3.50 units on a scale Standard Error 0.196	-3.38 units on a scale Standard Error 0.207
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 SDS Total Score Week 6	-5.73 units on a scale Standard Error 0.551	-7.65 units on a scale Standard Error 0.563	-6.88 units on a scale Standard Error 0.566
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 SDS Family Life/Home Responsibilities Week 12	-2.39 units on a scale Standard Error 0.177	-2.94 units on a scale Standard Error 0.178	-3.00 units on a scale Standard Error 0.189

SECONDARY outcome

Timeframe: baseline and 12 Weeks

Population: ITT

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

Outcome measures

Outcome measures
Measure	Placebo n=162 Participants Placebo, once daily	Dasotraline 4mg n=161 Participants Dasotraline 4mg once daily	Dasotraline 6mg n=162 Participants Dasotraline 6mg once daily
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 12	-1.1 units on a scale Standard Error 0.36	-0.9 units on a scale Standard Error 0.36	0.6 units on a scale Standard Error 0.36

SECONDARY outcome

Timeframe: baseline and 12 Weeks

Population: ITT

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.

Outcome measures

Outcome measures
Measure	Placebo n=162 Participants Placebo, once daily	Dasotraline 4mg n=161 Participants Dasotraline 4mg once daily	Dasotraline 6mg n=162 Participants Dasotraline 6mg once daily
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Week 12	-0.4 units on a scale Standard Error 0.37	0.3 units on a scale Standard Error 0.37	1.8 units on a scale Standard Error 0.37

SECONDARY outcome

Timeframe: 12 Weeks

Population: ITT

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

Outcome measures

Outcome measures
Measure	Placebo n=162 Participants Placebo, once daily	Dasotraline 4mg n=161 Participants Dasotraline 4mg once daily	Dasotraline 6mg n=162 Participants Dasotraline 6mg once daily
Proportion of Binge Eating Responders Who Have ≥ 75% Reduction in the Number of Binge Eating Episodes From Baseline at Week 12	91 Participants	112 Participants	123 Participants

SECONDARY outcome

Timeframe: baseline and 2 Weeks

Population: ITT

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.

Outcome measures

Outcome measures
Measure	Placebo n=162 Participants Placebo, once daily	Dasotraline 4mg n=161 Participants Dasotraline 4mg once daily	Dasotraline 6mg n=162 Participants Dasotraline 6mg once daily
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 EDE-QM Global Score Week 12 LOCF	-0.54 units on a scale Standard Error 0.116	-1.20 units on a scale Standard Error 0.116	-1.35 units on a scale Standard Error 0.118
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 EDE-QM Restraint Week 12 LOCF	-0.23 units on a scale Standard Error 0.149	-0.85 units on a scale Standard Error 0.149	-1.14 units on a scale Standard Error 0.152
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 EDE-QM Shape Concern Week 12 LOCF	-0.74 units on a scale Standard Error 0.132	-1.36 units on a scale Standard Error 0.132	-1.43 units on a scale Standard Error 0.135
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 EDE-QM Weight Concern Week 12 LOCF	-0.62 units on a scale Standard Error 0.129	-1.38 units on a scale Standard Error 0.130	-1.46 units on a scale Standard Error 0.132

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 70 other events

Deaths: 0 deaths

Dasotraline 4mg

Serious events: 3 serious events

Other events: 105 other events

Deaths: 0 deaths

Dasotraline 6mg

Serious events: 1 serious events

Other events: 113 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=163 participants at risk Placebo, once daily	Dasotraline 4mg n=161 participants at risk Dasotraline 4mg once daily	Dasotraline 6mg n=162 participants at risk Dasotraline 6mg once daily
Cardiac disorders Palpitations	0.00% 0/163 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)	0.62% 1/161 • Number of events 1 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)	0.00% 0/162 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)
Gastrointestinal disorders Hiatus hernia	0.00% 0/163 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)	0.62% 1/161 • Number of events 1 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)	0.00% 0/162 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)
Gastrointestinal disorders Inguinal hernia	0.00% 0/163 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)	0.62% 1/161 • Number of events 1 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)	0.00% 0/162 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)
Hepatobiliary disorders Cholecystitis	0.61% 1/163 • Number of events 1 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)	0.00% 0/161 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)	0.00% 0/162 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)
Psychiatric disorders Psychotic disorder	0.00% 0/163 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)	0.00% 0/161 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)	0.62% 1/162 • Number of events 1 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)

Other adverse events

Other adverse events
Measure	Placebo n=163 participants at risk Placebo, once daily	Dasotraline 4mg n=161 participants at risk Dasotraline 4mg once daily	Dasotraline 6mg n=162 participants at risk Dasotraline 6mg once daily
Gastrointestinal disorders Constipation	1.8% 3/163 • Number of events 4 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)	3.7% 6/161 • Number of events 6 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)	6.8% 11/162 • Number of events 11 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)
Gastrointestinal disorders Dry mouth	6.7% 11/163 • Number of events 11 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)	21.1% 34/161 • Number of events 34 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)	26.5% 43/162 • Number of events 45 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)
Gastrointestinal disorders Nausea	5.5% 9/163 • Number of events 10 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)	11.8% 19/161 • Number of events 22 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)	13.0% 21/162 • Number of events 25 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)
Infections and infestations Upper respiratory tract infection	14.1% 23/163 • Number of events 25 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)	6.8% 11/161 • Number of events 13 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)	8.0% 13/162 • Number of events 14 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)
Investigations Weight decreased	1.2% 2/163 • Number of events 2 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)	8.7% 14/161 • Number of events 14 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)	7.4% 12/162 • Number of events 12 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)
Metabolism and nutrition disorders Decreased appetite	6.7% 11/163 • Number of events 11 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)	9.3% 15/161 • Number of events 15 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)	16.0% 26/162 • Number of events 28 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)
Nervous system disorders Dizziness	1.8% 3/163 • Number of events 3 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)	5.0% 8/161 • Number of events 8 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)	5.6% 9/162 • Number of events 9 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)
Nervous system disorders Headache	10.4% 17/163 • Number of events 18 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)	12.4% 20/161 • Number of events 23 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)	16.7% 27/162 • Number of events 29 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)
Psychiatric disorders Anxiety	2.5% 4/163 • Number of events 4 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)	8.7% 14/161 • Number of events 14 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)	13.6% 22/162 • Number of events 24 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)
Psychiatric disorders Initial insomnia	2.5% 4/163 • Number of events 5 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)	6.2% 10/161 • Number of events 10 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)	8.6% 14/162 • Number of events 15 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)
Psychiatric disorders Insomnia	10.4% 17/163 • Number of events 17 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)	21.1% 34/161 • Number of events 35 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)	27.8% 45/162 • Number of events 46 • An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks) An AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete or discontinue this study but do not enter into the extension study), or through the last study day of the double-blind treatment period for subjects continuing into the extension study (double-blind treatment duration: 12 weeks)

Additional Information

CNS Medical Director

Sunovion Pharmaceuticals Inc.

Phone: 1-866-503-6351

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.
Publication restrictions are in place

Restriction type: OTHER