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

Shire

Status and phase: Completed; Phase 3

Conditions: Binge Eating Disorder

Treatments: Drug: SPD489 (Lisdexamfetamine dimesylate); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01718509

SPD489-344

2012-003310-14 (EudraCT Number)

Details and patient eligibility

About

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

Full description

Not Required

Enrollment: 390 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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390 participants in 2 patient groups, including a placebo group

SPD489 (Lisdexamfetamine dimesylate)

Experimental group

Treatment:

Drug: SPD489 (Lisdexamfetamine dimesylate)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo