Evaluate the Maintenance of Efficacy of 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: Other: Placebo; Drug: Lisdexamfetamine dimesylate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02009163

SPD489-346

2012-004457-88 (EudraCT Number)

Details and patient eligibility

About

To evaluate maintenance of efficacy based on time to relapse between SPD489 (50 or 70mg) and placebo, 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 and Clinical Global Impression - Severity (CGI-S) scores for patients who responded to SPD489 by the end of the Open-label Treatment Phase.

Enrollment: 418 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject is between 18-55 years of age, inclusive.

2. Subject meets the following 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.

3. Subject is consistently able to swallow a capsule.

Exclusion criteria

1. Subject has current diagnosis of bulimia nervosa or anorexia nervosa.
2. Subject is receiving psychotherapy or weight loss support within the past 3 months.
3. Subject has used psychostimulants to facilitate fasting or dieting within the past 6 months.
4. Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease.
5. Subject has abnormal thyroid function.
6. Subject initiated treatment with a lipid lowering medication within the past 3 months.
7. Subject has a history of moderate or severe hypertension.
8. Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder.
9. Subject has glaucoma.
10. Subject is female and pregnant or nursing.
11. Subjects who have 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: Quadruple Blind

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418 participants in 2 patient groups, including a placebo group

Lisdexamfetamine dimesylate

Experimental group

Description:

Administer one capsule (50 or 70 mg) orally daily at approximately 7:00 AM.

Treatment:

Drug: Lisdexamfetamine dimesylate

Placebo

Placebo Comparator group

Description:

Administer one capsule orally daily at approximately 7:00 AM.

Treatment:

Other: Placebo