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

Primary Purpose

Binge Eating Disorder

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Lisdexamfetamine dimesylate

About this trial

This is an interventional treatment trial for Binge Eating Disorder

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lisdexamfetamine dimesylate

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT01657019

First Posted

August 1, 2012

Last Updated

May 25, 2021

Sponsor

Shire

1. Study Identification

Unique Protocol Identification Number

NCT01657019

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

August 21, 2012 (Actual)

Primary Completion Date

October 21, 2014 (Actual)

Study Completion Date

October 21, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shire

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Binge Eating Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

604 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lisdexamfetamine dimesylate

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Lisdexamfetamine dimesylate

Other Intervention Name(s)

Vyvanse, SPD489, LDX

Intervention Description

50 or 70 mg administered orally, once a day for 52 weeks

Primary Outcome Measure Information:

Title

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety

Time Frame

52 weeks

Title

Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS)

Description

Time Frame

53 weeks

Secondary Outcome Measure Information:

Title

Percentage of Participants With an Improved Response on The Clinical Global Impressions of Improvement (CGI-I) Scale

Description

Time Frame

Weeks 1, 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination)

Title

Change From Baseline in The Global Score for The Eating Disorder Examination Questionnaire (EDE-Q)

Description

Time Frame

Baseline, Weeks 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination)

Title

Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility

Description

Time Frame