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

NCT01718483 | Completed Phase 3 Results

• 2 other identifiers: SPD489-3432012-003309-91
• Study Type: interventional
• Target: 383
• Locations: 4 countries
• Sites: 50

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Number of Binge Days Per Week at Visit 8 (Weeks 11-12)

  Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on participant binge diary.

  Baseline and Visit 8 (Weeks 11-12)

Secondary Outcomes (19)

• Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores

  Up to 12 weeks

• Percentage of Participants With a 4-Week Cessation From Binge Eating

  Up to 12 weeks

• Percent Change From Baseline in Body Weight at Week 12

  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

  Baseline and Week 12

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

  Baseline and Week 12/Early termination (ET)

Study Arms (2)

SPD489 (Lisdexamfetamine dimesylate)

EXPERIMENTAL

Drug: SPD489 (Lisdexamfetamine dimesylate)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SPD489 (Lisdexamfetamine dimesylate) DRUG

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

Also known as: Vyvanse, Venvanse, LDX

SPD489 (Lisdexamfetamine dimesylate)

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shire: lead

Study Sites (50)

Birmingham Research Group

Birmingham, Alabama, 35216, United States

Location

Clinical Study Centers, LLC

Little Rock, Arkansas, 72211, United States

Location

Trimed Clinical Trials

Corona, California, 92880, United States

Location

Pharmacology Research Institute

Encino, California, 91316, United States

Location

Pharmacology Research Institute

Los Alamitos, California, 90720, United States

Location

Pacific Research Partners, LLC

Oakland, California, 94812, United States

Location

Research Across America

Santa Ana, California, 92705, United States

Location

Western Affiliated Research Institute, Inc.

Denver, Colorado, 80209, United States

Location

Gulfcoast Clinical Research

Fort Myers, Florida, 33912, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32256, United States

Location

Fidelity Clinical Research, Inc.

Lauderhill, Florida, 33319, United States

Location

Compass Research LLC

Leesburg, Florida, 34748, United States

Location

Scientific Clinical Research Inc.

North Miami, Florida, 33161, United States

Location

Uptown Research Institute

Chicago, Illinois, 60640, United States

Location

Alexian Brothers Behavioral Health Hospital

Hoffman Estates, Illinois, 60169, United States

Location

AMR Baber Research, Inc.

Naperville, Illinois, 60563, United States

Location

Goldpoint Clinical Research, LLC

Indianapolis, Indiana, 46260, United States

Location

Cypress Medical Research Center, LLC

Wichita, Kansas, 67226, United States

Location

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

St. Charles Psychiatric Associates/Midwest Research Group

Saint Charles, Missouri, 63304, United States

Location

Center for Psychiatry and Behavioral Medicine, Inc.

Las Vegas, Nevada, 89128, United States

Location

Pacific Research for Research and Evaluation

Albuquerque, New Mexico, 87102, United States

Location

Wake Research Associates, LLC

Raleigh, North Carolina, 27612, United States

Location

Community Research

Cincinnati, Ohio, 45227, United States

Location

Midwest Clinical Research Center, LLC

Dayton, Ohio, 45417, United States

Location

North Star Medical Research

Middleburg Heights, Ohio, 44130, United States

Location

IPS Research Company

Oklahoma City, Oklahoma, 73103, United States

Location

Oregon Center for Clinical Investigations, Inc.

Salem, Oregon, 97301, United States

Location

The Clinical Trials Center, LLC

Jenkintown, Pennsylvania, 19046, United States

Location

Suburban Research Associates

Media, Pennsylvania, 19063, United States

Location

Clinical Trials Research Services, LLC

Pittsburgh, Pennsylvania, 15206, United States

Location

Radiant Research, Inc.

Anderson, South Carolina, 29621, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, 38119, United States

Location

Future Search Trials

Austin, Texas, 78731, United States

Location

Futuresearch Trials of Dallas, L.P.

Dallas, Texas, 75231, United States

Location

Grayline Clinical Drug Trials

Wichita Falls, Texas, 76309, United States

Location

Radiant Research, Inc.

Murray, Utah, 84123, United States

Location

Neuropsychiatric Associates, LLC

Woodstock, Vermont, 05091, United States

Location

Charlottesville Medical Research Center, LLC

Charlottesville, Virginia, 22911, United States

Location

Alliance Research Group

Richmond, Virginia, 23230, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

Dean Foundation for Health, Research and Educations, Inc.

Middleton, Wisconsin, 53562, United States

Location

Ernovis GmbH

Berlin, 10629, Germany

Location

Klinische Forschung Dresden GmbH

Dresden, 01069, Germany

Location

Studienzentrum Nordwest, Gemeinschaftspraxis

Westerstede, 26655, Germany

Location

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Location

Lakarmottagning Ekdahl & Kronberg

Malmo, 22152, Sweden

Location

Sophiahemmet

Stockholm, 11486, Sweden

Location

Stockholm Center for Eating Disorders

Stockholm, 11850, Sweden

Location

Related Publications (5)

• 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.

  PMID: 26346638 RESULT

• 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.

  PMID: 32237290 DERIVED

• 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.

  PMID: 30817099 DERIVED

• 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.

  PMID: 30013816 DERIVED

• 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.

  PMID: 29497297 DERIVED

MeSH Terms

Conditions

Binge-Eating Disorder

Interventions

Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2012
• First Posted: October 31, 2012
• Study Start: November 26, 2012
• Primary Completion: September 25, 2013
• Study Completion: September 25, 2013
• Last Updated: June 8, 2021
• Results First Posted: July 21, 2014

Record last verified: 2021-05

Locations

DE (3); SE (3); US (43); ES (1)