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

NCT ID: NCT01718483

Last Updated: 2021-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 383 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-26
• Study Completion Date: 2013-09-25

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

Conditions

Binge Eating Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SPD489 (Lisdexamfetamine dimesylate)

Group Type: EXPERIMENTAL

SPD489 (Lisdexamfetamine dimesylate)

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

SPD489 (Lisdexamfetamine dimesylate)

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Vyvanse, Venvanse, LDX

Eligibility Criteria

Inclusion Criteria

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

2. 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.

3. 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.

4. Female subjects must have a negative serum B HCG pregnancy test and a negative urine pregnancy test.

Exclusion Criteria

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 within 3 months.

3. Subject has used psychostimulants to facilitate fasting or dieting as a part of their BED within 6 months.

4. Subject has a lifetime history of psychosis, mania, hypomania, dementia, or ADHD.

5. 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.

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 recently initiated treatment with a lipid-lowering medication (within the past 3 months).

8. Subject has a history of moderate or severe hypertension.

9. Subject is female and pregnant or nursing.

10. Subjects who have had bariatric surgery, lap bands, duodenal stents, or other procedures for weight loss.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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

Encino, 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.

Jacksonville, Florida, United States

Fidelity Clinical Research, Inc.

Lauderhill, Florida, United States

Compass Research LLC

Leesburg, Florida, United States

Scientific Clinical Research Inc.

North Miami, Florida, United States

Uptown Research Institute

Chicago, Illinois, United States

Alexian Brothers Behavioral Health Hospital

Hoffman Estates, Illinois, United States

AMR Baber Research, Inc.

Naperville, Illinois, United States

Goldpoint Clinical Research, LLC

Indianapolis, Indiana, United States

Cypress Medical Research Center, LLC

Wichita, Kansas, United States

McLean Hospital

Belmont, Massachusetts, United States

St. Charles Psychiatric Associates/Midwest Research Group

Saint Charles, Missouri, United States

Center for Psychiatry and Behavioral Medicine, Inc.

Las Vegas, Nevada, United States

Pacific Research for Research and Evaluation

Albuquerque, New Mexico, United States

Wake Research Associates, LLC

Raleigh, North Carolina, United States

Community Research

Cincinnati, Ohio, United States

Midwest Clinical Research Center, LLC

Dayton, Ohio, United States

North Star Medical Research

Middleburg Heights, Ohio, United States

IPS Research Company

Oklahoma City, Oklahoma, United States

Oregon Center for Clinical Investigations, Inc.

Salem, Oregon, United States

The Clinical Trials Center, LLC

Jenkintown, Pennsylvania, United States

Suburban Research Associates

Media, Pennsylvania, United States

Clinical Trials Research Services, LLC

Pittsburgh, Pennsylvania, United States

Radiant Research, Inc.

Anderson, South Carolina, United States

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, United States

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, United States

Future Search Trials

Austin, Texas, United States

Futuresearch Trials of Dallas, L.P.

Dallas, Texas, United States

Grayline Clinical Drug Trials

Wichita Falls, Texas, United States

Radiant Research, Inc.

Murray, Utah, United States

Neuropsychiatric Associates, LLC

Woodstock, Vermont, United States

Charlottesville Medical Research Center, LLC

Charlottesville, Virginia, United States

Alliance Research Group

Richmond, Virginia, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Dean Foundation for Health, Research and Educations, Inc.

Middleton, Wisconsin, United States

Ernovis GmbH

Berlin, , Germany

Klinische Forschung Dresden GmbH

Dresden, , Germany

Studienzentrum Nordwest, Gemeinschaftspraxis

Westerstede, , Germany

Hospital Universitario Infanta Leonor

Madrid, , Spain

Lakarmottagning Ekdahl & Kronberg

Malmo, , Sweden

Sophiahemmet

Stockholm, , Sweden

Stockholm Center for Eating Disorders

Stockholm, , Sweden

Countries

United States; Germany; Spain; Sweden

References

McElroy SL, Hudson J, Ferreira-Cornwell MC, Radewonuk J, Whitaker T, Gasior M. Lisdexamfetamine Dimesylate for Adults with Moderate to Severe Binge Eating Disorder: Results of Two Pivotal Phase 3 Randomized Controlled Trials. Neuropsychopharmacology. 2016 Apr;41(5):1251-60. doi: 10.1038/npp.2015.275. Epub 2015 Sep 9.

Reference Type: RESULT

PMID: 26346638 (View on PubMed)

Robertson B, Wu J, Fant RV, Schnoll SH, McElroy SL. Assessment of Amphetamine Withdrawal Symptoms of Lisdexamfetamine Dimesylate Treatment for Adults With Binge-Eating Disorder. Prim Care Companion CNS Disord. 2020 Mar 26;22(2):19m02540. doi: 10.4088/PCC.19m02540.

Reference Type: DERIVED

PMID: 32237290 (View on PubMed)

Kornstein SG, Bliss C, Kando J, Madhoo M. Clinical Characteristics and Treatment Response to Lisdexamfetamine Dimesylate Versus Placebo in Adults With Binge Eating Disorder: Analysis by Gender and Age. J Clin Psychiatry. 2019 Feb 26;80(2):18m12378. doi: 10.4088/JCP.18m12378.

Reference Type: DERIVED

PMID: 30817099 (View on PubMed)

Sheehan DV, Gasior M, McElroy SL, Radewonuk J, Herman BK, Hudson J. Effects of Lisdexamfetamine Dimesylate on Functional Impairment Measured on the Sheehan Disability Scale in Adults With Moderate-to-severe Binge Eating Disorder: Results from Two Randomized, Placebo-controlled Trials. Innov Clin Neurosci. 2018 Jun 1;15(5-6):22-29.

Reference Type: DERIVED

PMID: 30013816 (View on PubMed)

Citrome L, Kando JC, Bliss C. Relationships between clinical scales and binge eating days in adults with moderate to severe binge eating disorder in two Phase III studies. Neuropsychiatr Dis Treat. 2018 Feb 15;14:537-546. doi: 10.2147/NDT.S158395. eCollection 2018.

Reference Type: DERIVED

PMID: 29497297 (View on PubMed)

Other Identifiers

2012-003309-91

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SPD489-343

Identifier Type: -

Identifier Source: org_study_id