SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on participant binge diary.

Time frame: Baseline and Visit 8 (Weeks 11-12)

Population: The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).

ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.

Time frame: Up to 12 weeks

Population: The Safety Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had at least 1 post-baseline safety assessment completed. Not all participants had data for this outcome.

Response is based on the reduction in the number of binge eating episodes. Percentage of participants with response was reported. Responses were categorized as follows: 1-week Cessation = 100% reduction in binge episodes during the preceding 7 days. Marked Reduction = 99% to 75% reduction during the time since the previous visit. Moderate Reduction = 74% to 50% reduction during the time since the previous visit. Negative to Minimal Reduction = \<50% reduction during the time since the previous visit.

Time frame: Week 12/ET

Population: The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.

The BES is a self-reported questionnaire containing 16 items designed to assess behavioral, affective, and attitudinal components of the subjective experience of binge eating. Each item is assessed based on 1 of 4 responses, with 1 denoting that a participant has greater control over eating behavior and 4 denoting that a participant had less control over eating behavior. A total score (sum of the 16 items) may range from 16-64. A lower score indicates greater control over eating behavior.

Time frame: Baseline and Week 12

Population: The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.

The Eating Inventory also known as the Three-Factor Eating Questionnaire is a 51-item self-reported questionnaire intended to assess 3 dimensions of eating behavior. There are 36 true/false items, 14 items on a 4-point Likert scale (1=eat rarely to 4=always), and 1 item on a 6-point Likert scale (1=eat whatever you want to 6=constantly limiting food intake). Cognitive Restraint score ranges from 0-21. Hunger score ranges from 0-14. Disinhibition score ranges from 0-16. Higher scores denote higher levels of restrained eating, disinhibited eating and predisposition to hunger.

Time frame: Baseline and Week 12

Population: The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.

Time frame: Baseline and Week 12/ET

Population: The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.

Time frame: Baseline and Week 12/Early termination (ET)

Population: The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.

The FrSBe is a 46-item self-rating scale designed to measure the neurobehavioral traits associated with the 3 primary regions of the prefrontal cortex. Participants were asked to indicate the frequency with which they have engaged in certain behaviors using a rating scale from 1 (almost never) to 5 (almost always). Summary scores were calculated and converted to t-score. A decrease from baseline in FrSBe total score represents improvement.

Time frame: Baseline and Week 12

Population: The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.

Time frame: Baseline and Week 12/ET

Population: The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.

Time frame: Baseline and Visit 8 (Weeks 11-12)

Population: The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).

The Y-BOCS-BE measures the obsession of binge-eating thoughts and compulsiveness of binge-eating behaviors. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). Total scores range from 0 to 40. Reduction in total score indicates improvement.

Time frame: Baseline and Week 12

Population: The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.

C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale. Number of participants with suicidal ideation and suicidal behavior were reported.

Time frame: Up to 12 weeks

Population: The Safety Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had at least 1 post-baseline safety assessment completed. Not all participants had data for this outcome.

Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various anxiety/depression conditions were reported.

Time frame: Up to 12 weeks

Population: The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.

Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various mobility conditions were reported.

Time frame: Up to 12 weeks

Population: The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.

Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various pain/discomfort conditions were reported.

Time frame: Up to 12 weeks

Population: The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.

Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various self-care conditions were reported.

Time frame: Up to 12 weeks

Population: The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.

Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various usual activities conditions were reported.

Time frame: Up to 12 weeks

Population: The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.

4-week cessation from binge eating is defined as no binge eating episodes for 28 consecutive days prior to the last study visit.

Time frame: Up to 12 weeks

Population: The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).

CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.

Time frame: Up to 12 weeks

Population: The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).

Time frame: Baseline and Week 12

Population: The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).