Binge Eating Disorder
Conditions
Brief summary
The primary objective of the study is to demonstrate the efficacy of SPD489 compared with placebo in adults (18 55 years of age inclusive) with moderate to severe Binge Eating Disorder at Visit 8 (Weeks 11 and 12) as measured by the number of binge days (defined as days during which at least 1 binge episode occurs) per week as assessed by clinical interview based on subject diary
Detailed description
Not Required
Interventions
50 or 70 mg administered orally, once-daily for up to 12 weeks
DRUGPlacebo
Administered once-daily, orally, for up to 12 weeks
Sponsors
Shire
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
The subject cannot be enrolled in the study before all of the following inclusion criteria (including test results) are met: 1. Subject is between 18-55 years of age. 2. Subject meets the following Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text Revision (DSM-IV-TR) criteria for a diagnosis of BED: 3. Subject has a BED diagnosis. 4. Subject's BED is of at least moderate severity with subjects reporting at least 3 binge eating days per week. 5. Female subjects must have a negative serum B-HCG pregnancy test and a negative urine pregnancy test and agree to comply with any applicable contraceptive requirements.
Exclusion criteria
Subjects are excluded from the study if any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Number of Binge Days Per Week at Visit 8 Which Spans Weeks 11/12 | Baseline and Visit 8 Which Spans Weeks 11/12 | Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on subject binge diary. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants With a 4-Week Cessation From Binge Eating | Up to 12 weeks | 4-week cessation from binge eating is defined as no binge eating episodes for 28 consecutive days prior to the last study visit. |
| Percent Change From Baseline in Body Weight (kg) at Week 12 | Baseline and week 12 | — |
| Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12 | Baseline and week 12 | 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. |
| Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks | Baseline and up to 12 weeks | — |
| Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks | Baseline and up to 12 weeks | — |
| Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks | Baseline and up to 12 weeks | — |
| Binge Eating Response | Up to 12 weeks | Response is based on the reduction in the number of binge eating episodes. 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 |
| Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 Which Spans Weeks 11/12 | Baseline and Visit 8 Which Spans Weeks 11/12 | — |
| Change From Baseline in Eating Inventory Scores at Week 12 | Baseline and week 12 | 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. |
| Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores | Up to 12 weeks | Clinical Global Impression-Improvement (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. |
| Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Up to 12 Weeks | Baseline and up to 12 weeks | 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. Subjects 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. |
| EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility | Up to 12 weeks | 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. |
| EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care | Up to 12 weeks | — |
| EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities | Up to 12 weeks | — |
| EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort | Up to 12 weeks | — |
| EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression | Up to 12 weeks | — |
| Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to 12 weeks | C-SSRS is a semi-structured interview that captures the occurence, 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. |
| Change in Amphetamine Cessation Symptom Assessment (ACSA) Total Score From Baseline to Week 12. | Baseline and Week 12 | 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. Calculated as Baseline (Day 0) - Week 12 ACSA scores. |
| Change From Baseline in Binge Eating Scale (BES) Score at Week 12 | Baseline and week 12 | 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 subject has greater control over eating behavior and 4 denoting that a subject 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. |
Countries
Germany, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PLACEBO | 185 |
| SPD489 | 181 |
| Total | 366 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 7 |
| Overall Study | Lack of Efficacy | 1 | 0 |
| Overall Study | Lost to Follow-up | 18 | 15 |
| Overall Study | Other | 13 | 11 |
| Overall Study | Protocol Violation | 4 | 2 |
| Overall Study | Withdrawal by Subject | 7 | 13 |
Baseline characteristics
| Characteristic | PLACEBO | SPD489 | Total |
|---|---|---|---|
| Age, Continuous | 38.7 Years STANDARD_DEVIATION 10.01 | 37.1 Years STANDARD_DEVIATION 10 | 37.9 Years STANDARD_DEVIATION 10.02 |
| Age, Customized < 40 years | 90 Participants | 108 Participants | 198 Participants |
| Age, Customized >= 40 years | 95 Participants | 73 Participants | 168 Participants |
| Region of Enrollment GERMANY | 9 Participants | 11 Participants | 20 Participants |
| Region of Enrollment UNITED STATES | 176 Participants | 170 Participants | 346 Participants |
| Sex: Female, Male Female | 153 Participants | 159 Participants | 312 Participants |
| Sex: Female, Male Male | 32 Participants | 22 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 43 / 185 | 100 / 181 |
| serious Total, serious adverse events | 2 / 185 | 1 / 181 |
Outcome results
Primary
Change From Baseline in the Number of Binge Days Per Week at Visit 8 Which Spans Weeks 11/12
Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on subject binge diary.
Time frame: Baseline and Visit 8 Which Spans Weeks 11/12
Population: The Full Analysis Set was defined as all randomized subjects who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (i.e., number of binge days per week calculated for at least 1 week).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PLACEBO | Change From Baseline in the Number of Binge Days Per Week at Visit 8 Which Spans Weeks 11/12 | -2.26 Binge days per week | Standard Error 0.137 |
| SPD489 | Change From Baseline in the Number of Binge Days Per Week at Visit 8 Which Spans Weeks 11/12 | -3.92 Binge days per week | Standard Error 0.135 |
p-value: <0.00195% CI: [-2.04, -1.28]Mixed Models Repeated Measures Analysis
Secondary
Binge Eating Response
Response is based on the reduction in the number of binge eating episodes. 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: Up to 12 weeks
Population: Full Analysis Set. Not all subjects had data for this outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PLACEBO | Binge Eating Response | 1-week cessation | 23.9 percentage of participants |
| PLACEBO | Binge Eating Response | Marked reduction | 13.4 percentage of participants |
| PLACEBO | Binge Eating Response | Moderate reduction | 19.7 percentage of participants |
| PLACEBO | Binge Eating Response | Negative to minimal reduction | 43.0 percentage of participants |
| SPD489 | Binge Eating Response | Negative to minimal reduction | 4.8 percentage of participants |
| SPD489 | Binge Eating Response | 1-week cessation | 55.9 percentage of participants |
| SPD489 | Binge Eating Response | Moderate reduction | 16.6 percentage of participants |
| SPD489 | Binge Eating Response | Marked reduction | 22.8 percentage of participants |
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Change From Baseline in Binge Eating Scale (BES) Score at Week 12
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 subject has greater control over eating behavior and 4 denoting that a subject 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: Full Analysis Set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PLACEBO | Change From Baseline in Binge Eating Scale (BES) Score at Week 12 | -8.24 units on a scale | Standard Error 0.781 |
| SPD489 | Change From Baseline in Binge Eating Scale (BES) Score at Week 12 | -17.52 units on a scale | Standard Error 0.771 |
p-value: <0.00195% CI: [-11.44, -7.12]Mixed Models Repeated Measures Analysis
Secondary
Change From Baseline in Eating Inventory Scores at Week 12
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: Full Analysis Set.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| PLACEBO | Change From Baseline in Eating Inventory Scores at Week 12 | Cognitive Restraint of Eating | 2.44 units on a scale | Standard Error 0.352 |
| PLACEBO | Change From Baseline in Eating Inventory Scores at Week 12 | Disinhibition of Eating | -2.01 units on a scale | Standard Error 0.305 |
| PLACEBO | Change From Baseline in Eating Inventory Scores at Week 12 | Perceived Hunger | -1.93 units on a scale | Standard Error 0.318 |
| SPD489 | Change From Baseline in Eating Inventory Scores at Week 12 | Cognitive Restraint of Eating | 3.71 units on a scale | Standard Error 0.347 |
| SPD489 | Change From Baseline in Eating Inventory Scores at Week 12 | Disinhibition of Eating | -5.61 units on a scale | Standard Error 0.3 |
| SPD489 | Change From Baseline in Eating Inventory Scores at Week 12 | Perceived Hunger | -6.14 units on a scale | Standard Error 0.313 |
Comparison: Cognitive Restraint of Eatingp-value: 0.01195% CI: [0.29, 2.24]Mixed Models Repeated Measures Analysis
Comparison: Disinhibition of Eatingp-value: <0.00195% CI: [-4.44, -2.76]Mixed Models Repeated Measures Analysis
Comparison: Perceived Hungerp-value: <0.00195% CI: [-5.09, -3.33]Mixed Models Repeated Measures Analysis
Secondary
Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks
Time frame: Baseline and up to 12 weeks
Population: Full Analysis Set. Not all subjects had data for this outcome.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PLACEBO | Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks | -0.126 mmol/L | Standard Error 0.046 |
| SPD489 | Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks | -0.204 mmol/L | Standard Error 0.0456 |
p-value: 0.23495% CI: [-0.205, 0.05]ANCOVA
Secondary
Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks
Time frame: Baseline and up to 12 weeks
Population: Full Analysis Set. Not all subjects had data for this outcome.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PLACEBO | Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks | 0.062 mmol/L | Standard Error 0.0453 |
| SPD489 | Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks | -0.133 mmol/L | Standard Error 0.0449 |
p-value: 0.00295% CI: [-0.321, -0.07]ANCOVA
Secondary
Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Up to 12 Weeks
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. Subjects 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 up to 12 weeks
Population: Full Analysis Set. Not all subjects had data for this outcome.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PLACEBO | Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Up to 12 Weeks | -3.09 t-scores | Standard Error 0.655 |
| SPD489 | Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Up to 12 Weeks | -4.05 t-scores | Standard Error 0.644 |
p-value: 0.29895% CI: [-2.77, 0.85]ANCOVA
Secondary
Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks
Time frame: Baseline and up to 12 weeks
Population: Full Analysis Set. Not all subjects had data for this outcome.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PLACEBO | Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks | -0.02 Percent | Standard Error 0.017 |
| SPD489 | Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks | 0.01 Percent | Standard Error 0.017 |
p-value: 0.18595% CI: [-0.02, 0.08]ANCOVA
Secondary
Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 Which Spans Weeks 11/12
Time frame: Baseline and Visit 8 Which Spans Weeks 11/12
Population: Full Analysis Set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PLACEBO | Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 Which Spans Weeks 11/12 | -3.31 Binge episodes per week | Standard Error 0.194 |
| SPD489 | Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 Which Spans Weeks 11/12 | -5.54 Binge episodes per week | Standard Error 0.193 |
p-value: <0.00195% CI: [-2.77, -1.69]Mixed Models Repeated Measures Analysis
Secondary
Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12
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: Full Analysis Set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PLACEBO | Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12 | -7.42 units on a scale | Standard Error 0.571 |
| SPD489 | Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12 | -15.36 units on a scale | Standard Error 0.563 |
p-value: <0.00195% CI: [-9.51, -6.36]Mixed Models Repeated Measures Analysis
Secondary
Change in Amphetamine Cessation Symptom Assessment (ACSA) Total Score From Baseline to Week 12.
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. Calculated as Baseline (Day 0) - Week 12 ACSA scores.
Time frame: Baseline and Week 12
Population: Safety Analysis Set who completed ACSC at Baseline \& Week 12 Visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PLACEBO | Change in Amphetamine Cessation Symptom Assessment (ACSA) Total Score From Baseline to Week 12. | 7.0 units on a scale | Standard Deviation 7.69 |
| SPD489 | Change in Amphetamine Cessation Symptom Assessment (ACSA) Total Score From Baseline to Week 12. | 4.6 units on a scale | Standard Deviation 5.83 |
Secondary
Columbia-Suicide Severity Rating Scale (C-SSRS)
C-SSRS is a semi-structured interview that captures the occurence, 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.
Time frame: Up to 12 weeks
Population: For this Outcome Measure the Safety Analysis Set is defined as all randomized subjects who took at least 1 dose of investigational product and who had at least 1 post-baseline safety assessment completed, and responded to the relevant questions for the C-SSRS. All subjects from Site 015 were excluded from the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PLACEBO | Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal ideation | 0 participants |
| PLACEBO | Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal behavior | 0 participants |
| SPD489 | Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal ideation | 0 participants |
| SPD489 | Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal behavior | 0 participants |
Secondary
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression
Time frame: Up to 12 weeks
Population: Full Analysis Set. Not all subjects had data for this outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PLACEBO | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression | Extremely anxious or depressed | 1.2 percentage of participants |
| PLACEBO | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression | Not anxious or depressed | 69.6 percentage of participants |
| PLACEBO | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression | Slightly anxious or depressed | 23.2 percentage of participants |
| PLACEBO | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression | Moderately anxious or depressed | 4.8 percentage of participants |
| PLACEBO | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression | Severely anxious or depressed | 1.2 percentage of participants |
| SPD489 | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression | Severely anxious or depressed | 0 percentage of participants |
| SPD489 | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression | Moderately anxious or depressed | 2.4 percentage of participants |
| SPD489 | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression | Not anxious or depressed | 76.3 percentage of participants |
| SPD489 | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression | Extremely anxious or depressed | 0.6 percentage of participants |
| SPD489 | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression | Slightly anxious or depressed | 20.7 percentage of participants |
Secondary
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility
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.
Time frame: Up to 12 weeks
Population: Full Analysis Set. Not all subjects had data for this outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PLACEBO | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility | Slight problems in walking about | 8.9 percentage of participants |
| PLACEBO | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility | Severe problems walking about | 1.2 percentage of participants |
| PLACEBO | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility | Moderate problems walking about | 3.0 percentage of participants |
| PLACEBO | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility | Unable to walk about | 0 percentage of participants |
| PLACEBO | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility | No problems in walking about | 86.9 percentage of participants |
| SPD489 | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility | Unable to walk about | 0 percentage of participants |
| SPD489 | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility | No problems in walking about | 91.7 percentage of participants |
| SPD489 | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility | Slight problems in walking about | 7.1 percentage of participants |
| SPD489 | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility | Moderate problems walking about | 0.6 percentage of participants |
| SPD489 | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility | Severe problems walking about | 0.6 percentage of participants |
Secondary
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort
Time frame: Up to 12 weeks
Population: Full Analysis Set. Not all subjects had data for this outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PLACEBO | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort | Slight pain or discomfort | 18.5 percentage of participants |
| PLACEBO | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort | Severe pain or discomfort | 3.0 percentage of participants |
| PLACEBO | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort | Moderate pain or discomfort | 3.0 percentage of participants |
| PLACEBO | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort | Extreme pain or discomfort | 0 percentage of participants |
| PLACEBO | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort | No pain or discomfort | 75.6 percentage of participants |
| SPD489 | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort | Extreme pain or discomfort | 0.6 percentage of participants |
| SPD489 | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort | No pain or discomfort | 76.3 percentage of participants |
| SPD489 | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort | Slight pain or discomfort | 20.1 percentage of participants |
| SPD489 | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort | Moderate pain or discomfort | 3.0 percentage of participants |
| SPD489 | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort | Severe pain or discomfort | 0 percentage of participants |
Secondary
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care
Time frame: Up to 12 weeks
Population: Full Analysis Set. Not all subjects had data for this outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PLACEBO | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care | Slight problems washing or dressing | 2.4 percentage of participants |
| PLACEBO | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care | Severe problems washing or dressing | 0 percentage of participants |
| PLACEBO | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care | Moderate problems washing or dressing | 0.6 percentage of participants |
| PLACEBO | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care | Unable to wash or dress | 0 percentage of participants |
| PLACEBO | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care | No problems washing or dressing | 97.0 percentage of participants |
| SPD489 | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care | Unable to wash or dress | 0 percentage of participants |
| SPD489 | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care | No problems washing or dressing | 97.0 percentage of participants |
| SPD489 | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care | Slight problems washing or dressing | 3.0 percentage of participants |
| SPD489 | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care | Moderate problems washing or dressing | 0 percentage of participants |
| SPD489 | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care | Severe problems washing or dressing | 0 percentage of participants |
Secondary
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities
Time frame: Up to 12 weeks
Population: Full Analysis Set. Not all subjects had data for this outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PLACEBO | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities | Slight problems dosin usual activities | 14.3 percentage of participants |
| PLACEBO | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities | Severe problems doing usual activities | 0.6 percentage of participants |
| PLACEBO | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities | Moderate problems doing usual activities | 3.0 percentage of participants |
| PLACEBO | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities | Unable to do usual activities | 0 percentage of participants |
| PLACEBO | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities | No problems doing usual activities | 82.1 percentage of participants |
| SPD489 | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities | Unable to do usual activities | 0 percentage of participants |
| SPD489 | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities | No problems doing usual activities | 89.9 percentage of participants |
| SPD489 | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities | Slight problems dosin usual activities | 8.3 percentage of participants |
| SPD489 | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities | Moderate problems doing usual activities | 1.2 percentage of participants |
| SPD489 | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities | Severe problems doing usual activities | 0.6 percentage of participants |
Secondary
Percent Change From Baseline in Body Weight (kg) at Week 12
Time frame: Baseline and week 12
Population: Full Analysis Set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PLACEBO | Percent Change From Baseline in Body Weight (kg) at Week 12 | -0.15 percentage change | Standard Error 0.353 |
| SPD489 | Percent Change From Baseline in Body Weight (kg) at Week 12 | -5.57 percentage change | Standard Error 0.35 |
p-value: <0.00195% CI: [-6.39, -4.44]Mixed Models Repeated Measures Analysis
Secondary
Percent of Participants With a 4-Week Cessation From Binge Eating
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: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PLACEBO | Percent of Participants With a 4-Week Cessation From Binge Eating | 13.1 percentage of participants |
| SPD489 | Percent of Participants With a 4-Week Cessation From Binge Eating | 36.2 percentage of participants |
p-value: <0.001Chi-squared
Secondary
Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
Clinical Global Impression-Improvement (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: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PLACEBO | Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores | 42.9 percentage of participants |
| SPD489 | Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores | 86.2 percentage of participants |
p-value: <0.001Chi-squared