SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder
This study is currently recruiting participants.
Verified May 2013 by Shire Development LLC
Information provided by (Responsible Party):
Shire Development LLC
First received: October 29, 2012
Last updated: May 16, 2013
Last verified: May 2013
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
Binge Eating Disorder
Drug: SPD489 (Lisdexamfetamine dimesylate)
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
||The SPD489-343, Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-optimization Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder
Primary Outcome Measures:
- Binge Days Per Week [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Clinical Global Impression-Improvement (CGI-I) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
- 4-Week Cessation From Binge Eating Behavior [ Time Frame: Last 28 days prior to final visit ] [ Designated as safety issue: No ]
- Body Weight [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
- Triglyceride Levels [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
- Cholesterol Levels [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
- Glycosolated Hemoglobin (HbA1c) Levels [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
- Binge Episodes Per Week [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
- 1-Week Cessation From Binge Eating Behavior [ Time Frame: last 7 days prior to visit ] [ Designated as safety issue: No ]
- Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Score [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
- Eating Inventory Score (also known as the Three-Factor Eating Questionnaire) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
- Binge Eating Scale (BES) Score [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
- Frontal Systems Behavior Score (FrSBe) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
- EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
- Amphetamine Cessation Symptom Assessment (ACSA) Total Score [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||May 2014 (Final data collection date for primary outcome measure)
Experimental: SPD489 (Lisdexamfetamine dimesylate)
Drug: SPD489 (Lisdexamfetamine dimesylate)
50 or 70 mg administered orally, once-daily for up to 12 weeks
Other Name: Vyvanse, Venvanse, LDX
Placebo Comparator: Placebo
Administered once-daily, orally, for up to 12 weeks
|Ages Eligible for Study:
||18 Years to 55 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Inclusion Criteria -
- Subject is between 18-55 years of age.
Subject meets the following DSM-IV-TR criteria for a diagnosis of BED:
Recurrent episodes of binge eating. An episode of binge eating is characterized by both of the following: eating, in a discrete period of time (eg, within a 2-hour period) an amount of food that is definitely larger than most people would eat in a similar period of time under similar conditions, and a sense of lack of control over the eating (eg, a feeling that one cannot stop eating or control what or how much one is eating).
The binge eating episodes are associated with at least 3 of the following: eating much more rapidly than normal; eating until uncomfortably full; eating large amounts of food when not feeling physically hungry; eating alone because of being embarrassed by how much one is eating; feeling disgusted with oneself, depressed, or feeling very guilty after overeating.
Marked distress regarding binge eating. The binge eating occurs, on average, at least 2 days a week for 6 months. The episodes of binge eating do not occur exclusively during the course of bulimia nervosa or anorexia nervosa.
- Subject's BED is of at least moderate severity with subjects reporting at least 3 binge eating days per week for the 14 days prior to the Baseline Visit (Visit 0) as documented in the subject's binge diary. A binge day is a day during which at least 1 binge eating episode occurs.
- Female subjects must have a negative serum B HCG pregnancy test and a negative urine pregnancy test.
- Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa.
- Subject is receiving psychotherapy (eg, supportive psychotherapy, cognitive behavior therapy, interpersonal therapy) or weight loss support (eg, Weight Watchers) for BED within 3 months.
- Subject has used psychostimulants to facilitate fasting or dieting as a part of their BED within 6 months.
- Subject has a lifetime history of psychosis, mania, hypomania, dementia, or ADHD.
- Subject is considered a suicide risk in the opinion of the investigator, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the investigator.
- 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.
- Subject has recently initiated treatment with a lipid-lowering medication (within the past 3 months).
- Subject has a history of moderate or severe hypertension.
- Subject is female and pregnant or nursing.
- Subjects who have had bariatric surgery, lap bands, duodenal stents, or other procedures for weight loss.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718483
|Contact: Shire Call Center
Shire Development LLC
||Susan McElroy, MD
||University of Cincinnati
No publications provided
||Shire Development LLC
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 29, 2012
||May 16, 2013
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 16, 2013
Signs and Symptoms, Digestive
Signs and Symptoms
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents