Open Label Extension in Adults With Binge Eating Disorder (BED)

Study Overview
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Brief Summary
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To evaluate the safety and tolerability of SPD489 administered as a daily morning dose (50 or 70mg) in the treatment of moderate to severe binge eating disorder (BED) in adults

Official Title
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A Phase 3, Multicenter, Open-label, 12 Month Extension Safety and Tolerability Study of SPD489 in the Treatment of Adults With Binge Eating Disorder

Conditions
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Binge Eating Disorder

Intervention / Treatment
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* Drug: Lisdexamfetamine dimesylate


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Completion of an antecedent SPD489 BED Double-blind Study Subject meets the following Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text Revision (DSM-IV-TR) criteria for a diagnosis of BED Subject has a body mass index (BMI) of > or =18 and < or =45 Exclusion criteria: Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa. Subject is considered a suicide risk or risk to harm others

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lisdexamfetamine dimesylate<br> | Drug: Lisdexamfetamine dimesylate<br>* 50 or 70 mg administered orally, once a day for 52 weeks<br>* Other names: LDX;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety |  | 52 weeks | 
| Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS) | Suicidality was assessed by using the C-SSRS, a semi-structured interview designed to capture the occurrence, severity, and frequency of suicide-related thoughts and behaviors. The interview and rating for the C-SSRS was completed by a clinician who had been successfully trained by the sponsor or designee. The interview was initiated with 5 (yes/no) questions, presented in ascending order of severity, about suicidal ideation. The most severe type of ideation was rated for frequency, duration, controllability, deterrents, and reason. If the answers to the first 2 ideation questions were yes, the clinician asked questions 3-5. Active suicidal ideation included any participant who answered yes to questions 2-5. If the answers to ideation questions 1 and 2 were no, then the clinician proceeded to 5 (yes/no) questions that addressed suicidal behavior, which was categorized as actual attempt, interrupted attempt, aborted attempt, preparatory acts or behaviors, and completed suicide. | 53 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With an Improved Response on The Clinical Global Impressions of Improvement (CGI-I) Scale | The CGI rating scales permitted the global evaluation of a participant's condition severity and improvement over time. The CGI-I was performed to rate the improvement of a participant's condition on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse) and included a 'not assessed' option. The responses were dichotomized into 2 categories (improved or not improved). Improved included very much improved and much improved; not improved included minimally improved, no change, minimally worse, much worse, and very much worse. Not assessed and missing values were excluded from the percentage calculation. | Weeks 1, 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination) | 
| Change From Baseline in The Global Score for The Eating Disorder Examination Questionnaire (EDE-Q) | The EDE-Q is a 28-item questionnaire measuring eating pathology and is derived directly from the Eating Disorder Examination Interview. The EDE-Q focuses on the past 28 days to assess the main behavioral (eating and purging) and attitudinal features of eating disorders. The 28 items are rated by the participant on a 7-point scale (ranging from 0 to 6), with higher scores indicating increased pathology. The EDE-Q includes 4 subscales: Restraint, Eating Concern, Weight Concern, and Shape Concern. The global score is the average of all 28 items, with a range of 0 to 6. A negative value indicates a favorable result. The values presented are the mean change from baseline. | Baseline, Weeks 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination) | 
| Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility | The EQ-5D-5L 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. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the mobility questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit. | End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) | 
| Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care | The EQ-5D-5L 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. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the self care questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit. | End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) | 
| Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities | The EQ-5D-5L 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. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the usual activities questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit. | End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) | 
| Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort | The EQ-5D-5L 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. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the pain/discomfort questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit. | End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) | 
| Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety or Depression | The EQ-5D-5L 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. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the anxiety/depression questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit. | End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) |