| Primary | Change From Baseline in Log Transformed Binge Days Per Week at Week 11 | Binge day is defined as a day during which at least 1 binge episode occurs. | Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. | Posted | | Least Squares Mean | Standard Error | Log days | | Baseline and week 11 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsule taken once daily for up to 11 weeks | | OG001 | Lisdexamfetamine Dimesylate (SPD489) 30 mg | SPD489-30mg capsules taken once daily for up to 11 weeks | | OG002 | Lisdexamfetamine Dimesylate (SPD489) 50 mg | SPD489 50mg capsules taken once-daily for up to 11 weeks | | OG003 | Lisdexamfetamine Dimesylate (SPD489) 70 mg | SPD489 70mg capsule taken once-daily for up to 11 weeks |
| | Units | Counts |
|---|
| Participants | - OG00062
- OG00166
- OG00264
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-1.23± 0.069
- OG001-1.24± 0.067
- OG002-1.49± 0.066
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Mixed Models Analysis | | 0.8825 | | Mean Difference (Final Values) | -0.014 | | | 2-Sided | 95 | -0.203 | 0.175 | | | | | Superiority or Other (legacy) | | | | | Mixed Models Analysis | | 0.0077 |
|
| Secondary | Change From Baseline in the Number of Binge Episodes Per Week at Up to 11 Weeks | The number of binge episodes per week as assessed by clinical interview based on subject diary. | Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. | Posted | | Mean | Standard Deviation | Binge Episodes | | Baseline and up to 11 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsule taken once daily for up to 11 weeks | | OG001 | Lisdexamfetamine Dimesylate (SPD489) 30 mg | SPD489-30mg capsules taken once daily for up to 11 weeks | | OG002 | Lisdexamfetamine Dimesylate (SPD489) 50 mg | SPD489 50mg capsules taken once-daily for up to 11 weeks | | OG003 | Lisdexamfetamine Dimesylate (SPD489) 70 mg | SPD489 70mg capsule taken once-daily for up to 11 weeks |
| |
| Secondary | 1-Week Binge Response, Last Observation Carried Forward (LOCF) | The 1-week binge response was defined as either a 1-week remission (a 100% reduction of binge episodes from baseline [ie, a cessation of binge eating behavior]), or a marked response (75 to <100% reduction in binge episodes from baseline), or a moderate response (50 to <75% reduction in binge episodes from baseline), or a negative/minimal response (<50% reduction in binge episodes from baseline). The 1-week response was determined at the end of the study utilizing a LOCF approach. | Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. | Posted | | Number | | Participants | | Last 7 days on study | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsule taken once daily for up to 11 weeks | | OG001 | Lisdexamfetamine Dimesylate (SPD489) 30 mg | SPD489-30mg capsules taken once daily for up to 11 weeks | | OG002 | Lisdexamfetamine Dimesylate (SPD489) 50 mg | SPD489 50mg capsules taken once-daily for up to 11 weeks | | OG003 |
|
| Secondary | 4-Week Binge Response | Subjects are free from binge episodes for 4 weeks. | Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. | Posted | | Number | | Participants | | Last 28 days on study | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsule taken once daily for up to 11 weeks | | OG001 | Lisdexamfetamine Dimesylate (SPD489) 30 mg | SPD489-30mg capsules taken once daily for up to 11 weeks | | OG002 | Lisdexamfetamine Dimesylate (SPD489) 50 mg | SPD489 50mg capsules taken once-daily for up to 11 weeks | | OG003 | Lisdexamfetamine Dimesylate (SPD489) 70 mg | SPD489 70mg capsule taken once-daily for up to 11 weeks |
| |
| Secondary | Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline | CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill) | Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. (Not all subjects in the FAS had an assessment for this outcome.) | Posted | | Number | | Percentage of participants | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsule taken once daily for up to 11 weeks | | OG001 | Lisdexamfetamine Dimesylate (SPD489) 30 mg | SPD489-30mg capsules taken once daily for up to 11 weeks | | OG002 | Lisdexamfetamine Dimesylate (SPD489) 50 mg | SPD489 50mg capsules taken once-daily for up to 11 weeks | | OG003 | Lisdexamfetamine Dimesylate (SPD489) 70 mg | SPD489 70mg capsule taken once-daily for up to 11 weeks |
|
| Secondary | Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Up to 11 Weeks | CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill) | Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. (Not all subjects in the FAS had an assessment for this outcome.) | Posted | | Number | | Percentage of participants | | up to 11 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsule taken once daily for up to 11 weeks | | OG001 | Lisdexamfetamine Dimesylate (SPD489) 30 mg | SPD489-30mg capsules taken once daily for up to 11 weeks | | OG002 | Lisdexamfetamine Dimesylate (SPD489) 50 mg | SPD489 50mg capsules taken once-daily for up to 11 weeks | | OG003 | Lisdexamfetamine Dimesylate (SPD489) 70 mg | SPD489 70mg capsule taken once-daily for up to 11 weeks |
|
| Secondary | Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Up to 11 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. | Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. (Not all subjects in the FAS had an assessment for this outcome.) | Posted | | Number | | Percentage of participants | | Up to 11 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsule taken once daily for up to 11 weeks | | OG001 | Lisdexamfetamine Dimesylate (SPD489) 30 mg | SPD489-30mg capsules taken once daily for up to 11 weeks | | OG002 | Lisdexamfetamine Dimesylate (SPD489) 50 mg | SPD489 50mg capsules taken once-daily for up to 11 weeks | | OG003 | Lisdexamfetamine Dimesylate (SPD489) 70 mg | |
|
| Secondary | Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Total Score at Week 11 | The YBOCS-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. A score of 0-7 is sub-clinical; 8-15 is mild; 16-23 is moderate; 24-31 is severe; and 32-40 is extreme. | Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline and week 11 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsule taken once daily for up to 11 weeks | | OG001 | Lisdexamfetamine Dimesylate (SPD489) 30 mg | SPD489-30mg capsules taken once daily for up to 11 weeks | | OG002 | Lisdexamfetamine Dimesylate (SPD489) 50 mg | SPD489 50mg capsules taken once-daily for up to 11 weeks | | OG003 | Lisdexamfetamine Dimesylate (SPD489) 70 mg |
|
| Secondary | Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Score at Week 11 | MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression. | Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline and week 11 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsule taken once daily for up to 11 weeks | | OG001 | Lisdexamfetamine Dimesylate (SPD489) 30 mg | SPD489-30mg capsules taken once daily for up to 11 weeks | | OG002 | Lisdexamfetamine Dimesylate (SPD489) 50 mg | SPD489 50mg capsules taken once-daily for up to 11 weeks | | OG003 | Lisdexamfetamine Dimesylate (SPD489) 70 mg | SPD489 70mg capsule taken once-daily for up to 11 weeks |
|
| Secondary | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score at Week 11 | The HAM-A is a rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe) with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity, and 25-30 moderate to severe, and 31-56 severe anxiety. | Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline and week 11 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsule taken once daily for up to 11 weeks | | OG001 | Lisdexamfetamine Dimesylate (SPD489) 30 mg | SPD489-30mg capsules taken once daily for up to 11 weeks | | OG002 | Lisdexamfetamine Dimesylate (SPD489) 50 mg | SPD489 50mg capsules taken once-daily for up to 11 weeks | | OG003 | Lisdexamfetamine Dimesylate (SPD489) 70 mg |
|
| Secondary | Change From Baseline in Eating Inventory Score at Week 11 | 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: cognitive restraint of eating, disinhibition, and hunger. Cognitive restraint of eating consists of 20 items, disinhibition consists of 16 items, and hunger consists of 15 items. Each item scores either 0 or 1 point for a total score of 0-20 for cognitive restraint of eating, 0-16 for disinhibition, and 0-15 for hunger. A higher score is better for cognitive restraint of eating and lower scores are better for disinhibition and hunger. | Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline and week 11 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsule taken once daily for up to 11 weeks | | OG001 | Lisdexamfetamine Dimesylate (SPD489) 30 mg | SPD489-30mg capsules taken once daily for up to 11 weeks | | OG002 | Lisdexamfetamine Dimesylate (SPD489) 50 mg | SPD489 50mg capsules taken once-daily for up to 11 weeks |
|
| Secondary | Change From Baseline in Binge Eating Scale (BES) Score at Week 11 | The BES is a 16-item self-reported questionnaire that is designed to assess behavioral, affective, and attitudinal components of the subjective experience of binge eating. The items are summed, with possible scores ranging from 0 to 46. A score of 27 or higher indicates severe binge-eating problems, and a score of 17 or lower designates no binge-eating problems. | Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline and week 11 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsule taken once daily for up to 11 weeks | | OG001 | Lisdexamfetamine Dimesylate (SPD489) 30 mg | SPD489-30mg capsules taken once daily for up to 11 weeks | | OG002 | Lisdexamfetamine Dimesylate (SPD489) 50 mg | SPD489 50mg capsules taken once-daily for up to 11 weeks | | OG003 | Lisdexamfetamine Dimesylate (SPD489) 70 mg |
|
| Secondary | Change From Baseline in Barratt Impulsiveness Scale (BIS-11) Total Score at Week 11 | The BIS-11 is a self-reported 30-item questionnaire that measures impulsiveness using a 4-point Likert scale (rarely/never = 1, occasionally = 2, often = 3, almost always/always = 4). A Total Impulsivity score is calculated by summing the scores for each item. Possible scores range from 30 - 120. Higher scores indicate increased impulsiveness. | Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline and week 11 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsule taken once daily for up to 11 weeks | | OG001 | Lisdexamfetamine Dimesylate (SPD489) 30 mg | SPD489-30mg capsules taken once daily for up to 11 weeks | | OG002 | Lisdexamfetamine Dimesylate (SPD489) 50 mg | SPD489 50mg capsules taken once-daily for up to 11 weeks | | OG003 | Lisdexamfetamine Dimesylate (SPD489) 70 mg |
|
| Secondary | Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Week 11 | The SF-12 is a 12-item self-report questionnaire that is a subset of the SF-36 Health Survey. The survey captures physical and mental health. There are 8 subscales. Four of the subscales has one-item each; the other 4 have two-items each. For each subscale, a mean value was first computed and transformed to a position on a scale ranging from 0-100 (Z-transformation). The aggregate total scores are then transformed into a mean value ranging from 0 (lowest level of health) to 100 (highest level of health). | Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline and week 11 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo capsule taken once daily for up to 11 weeks | | OG001 | Lisdexamfetamine Dimesylate (SPD489) 30 mg | SPD489-30mg capsules taken once daily for up to 11 weeks | | OG002 | Lisdexamfetamine Dimesylate (SPD489) 50 mg | SPD489 50mg capsules taken once-daily for up to 11 weeks |
|