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

Shire390 enrolled

Overview

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

Not Required

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

390

Conditions

Binge Eating Disorder

Interventions

SPD489 (Lisdexamfetamine dimesylate)DRUG

50 or 70 mg administered orally, once-daily for up to 12 weeks

PlaceboDRUG

Administered once-daily, orally, for up to 12 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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 exclusion criteria are met: 1. Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa. 2. Subject is receiving psychotherapy (eg, supportive psychotherapy, cognitive behavior therapy, interpersonal therapy) or weight loss support (eg, Weight Watchers) for BED. 3. Subject has used psychostimulants to facilitate fasting or dieting as a part of their BED. 4. Subject has a lifetime history of psychosis, mania, hypomania, dementia, or ADHD. 5. Subject is considered a suicide risk, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation. 6. Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. 7. Subject has a history of moderate or severe hypertension. 8. Subject is female and pregnant or nursing. 9. Subject has had bariatric surgery, lap bands, duodenal stents, or other procedures for weight loss.

Locations (48)

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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

Percent Change From Baseline in Body Weight (kg) at Week 12

Time frame: 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

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

Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks

Time frame: Baseline and up to 12 weeks

Data from ClinicalTrials.gov

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Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks

Time frame: Baseline and up to 12 weeks

Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks

Time frame: Baseline and up to 12 weeks

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

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

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

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

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

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

EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care

Time frame: Up to 12 weeks

EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities

Time frame: Up to 12 weeks

EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort

Time frame: Up to 12 weeks

EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression

Time frame: Up to 12 weeks

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

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