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

Phase 3

Completed

Conditions: Binge Eating Disorder

Interventions: Drug: SPD489 (Lisdexamfetamine dimesylate)
Drug: Placebo

Registration Number: NCT01718483

Lead Sponsor: Shire

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 available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 383

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPD489 (Lisdexamfetamine dimesylate)	SPD489 (Lisdexamfetamine dimesylate)	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Number of Binge Days Per Week at Visit 8 (Weeks 11-12)	Baseline and Visit 8 (Weeks 11-12)	Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on participant binge diary.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks	Baseline and Week 12/Early termination (ET)
Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks	Baseline and Week 12/ET
Binge Eating Response	Week 12/ET	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.
Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 (Weeks 11-12)	Baseline and Visit 8 (Weeks 11-12)
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 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.
Percentage 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.
Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks	Baseline and Week 12/ET
Percent Change From Baseline in Body Weight at Week 12	Baseline and Week 12
Change From Baseline in Eating Inventory Scores at Week 12	Baseline and Week 12	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.
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.
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. Percentage of participants with various mobility conditions were reported.
Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores	Up to 12 weeks	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 Week 12	Baseline and Week 12	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.
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression	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. Percentage of participants with various anxiety/depression conditions were reported.
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care	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. Percentage of participants with various self-care conditions were reported.
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities	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. Percentage of participants with various usual activities conditions were reported.
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort	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. Percentage of participants with various pain/discomfort conditions were reported.
Amphetamine Cessation Symptom Assessment (ACSA) Total Score	Up to 12 weeks	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.
Columbia-Suicide Severity Rating Scale (C-SSRS)	Up to 12 weeks	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.

Trial Locations

Locations (47): Birmingham Research Group
🇺🇸
Birmingham, Alabama, United States
Clinical Study Centers, LLC
🇺🇸
Little Rock, Arkansas, United States
Trimed Clinical Trials
🇺🇸
Corona, California, United States
Pharmacology Research Institute
🇺🇸
Los Alamitos, California, United States
Pacific Research Partners, LLC
🇺🇸
Oakland, California, United States
Research Across America
🇺🇸
Santa Ana, California, United States
Western Affiliated Research Institute, Inc.
🇺🇸
Denver, Colorado, United States
Gulfcoast Clinical Research
🇺🇸
Fort Myers, Florida, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸
Memphis, Tennessee, United States
Fidelity Clinical Research, Inc.
🇺🇸
Lauderhill, Florida, United States
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Birmingham Research Group
🇺🇸Birmingham, Alabama, United States