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

NCT01718509 | Completed Phase 3 Results

• 2 other identifiers: SPD489-3442012-003310-14
• Study Type: interventional
• Target: 390
• Locations: 2 countries
• Sites: 48

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 Which Spans Weeks 11/12

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

  Baseline and Visit 8 Which Spans Weeks 11/12

Secondary Outcomes (19)

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

  Up to 12 weeks

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

  Up to 12 weeks

• Percent Change From Baseline in Body Weight (kg) 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 up to 12 weeks

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 Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text Revision (DSM-IV-TR) criteria for a diagnosis of BED:
• Subject has a BED diagnosis.
• Subject's BED is of at least moderate severity with subjects reporting at least 3 binge eating days per week.
• 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.

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.
• Subject has used psychostimulants to facilitate fasting or dieting as a part of their BED.
• Subject has a lifetime history of psychosis, mania, hypomania, dementia, or ADHD.
• Subject is considered a suicide risk, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation.
• 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 a history of moderate or severe hypertension.
• Subject is female and pregnant or nursing.
• Subject has had bariatric surgery, lap bands, duodenal stents, or other procedures for weight loss.

Sponsors & Collaborators

• Shire: lead

Study Sites (48)

Radiant Research, Inc.

Tucson, Arizona, 85710, United States

Location

Southern California Research, LLC

Beverly Hills, California, 90210, United States

Location

Scripps Clinical Research Services

La Jolla, California, 92037, United States

Location

Pharmacology Research Institute

Newport Beach, California, 92660, United States

Location

Excel Research, Inc.

Oceanside, California, 92056, United States

Location

PCSD - Feighner Research

San Diego, California, 92108, United States

Location

Radiant Research, Inc.

Denver, Colorado, 80239, United States

Location

Florida Clinical Research Center, LLC

Bradenton, Florida, 34201, United States

Location

Florida Clinical Research Center, LLC

Maitland, Florida, 32751, United States

Location

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32806, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

NeuroTrials Research, Inc.

Atlanta, Georgia, 30342, United States

Location

Capstone Clinical Research

Libertyville, Illinois, 60048, United States

Location

American Medical Research

Oak Brook, Illinois, 60523, United States

Location

Deaconess Clinic Gateway Health Center

Newburgh, Indiana, 47630, United States

Location

Clinical Trials Technology, Inc.

Prairie Village, Kansas, 66206, United States

Location

Louisiana Research Associates, Inc.

New Orleans, Louisiana, 70114, United States

Location

Potomac Grove Clinical Research Center

Gaithersburg, Maryland, 20877, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

Activmed Practices and Research

Haverhill, Massachusetts, 01830, United States

Location

Adams Clinical Trials, LLC

Watertown, Massachusetts, 02472, United States

Location

Rochester Center for Behavioral Medicine

Rochester Hills, Michigan, 48307, United States

Location

UMN Medical School, Dept of Psychiatry

Minneapolis, Minnesota, 55454, United States

Location

Scientella, LLA

St Louis, Missouri, 63141, United States

Location

Robert Lynn Horne, MD, LTD

Las Vegas, Nevada, 89102, United States

Location

Global Medical Inst LLC; Princeton Medical Institute

Princeton, New Jersey, 08540, United States

Location

Bioscience Research, LLC

Mount Kisco, New York, 10549, United States

Location

CNS Clinica at the Brain Resource Center

New York, New York, 10023, United States

Location

Radiant Research, Inc.

Akron, Ohio, 44311, United States

Location

Patient Priority Clinical Sites, LLC

Cincinnati, Ohio, 45215, United States

Location

The Craig and Frances Lindner Center of Hope

Mason, Ohio, 45040, United States

Location

Clinical Trials of America, Inc.

Eugene, Oregon, 97401, United States

Location

Sunstone Medical Research, LLC

Medford, Oregon, 97504, United States

Location

Oregon Center for Clinical Investigators (OCCI, Inc)

Portland, Oregon, 97210, United States

Location

Lehigh Center for Clinical Research

Allentown, Pennsylvania, 18104, United States

Location

CRI Lifetree

Philadelphia, Pennsylvania, 19139, United States

Location

Omega Medical Reserach

Warwick, Rhode Island, 02886, United States

Location

Radiant Research, Inc.

Greer, South Carolina, 29650, United States

Location

Clinical Research Associates, Inc.

Nashville, Tennessee, 37203, United States

Location

Texas Center for Drug Development, Inc.

Houston, Texas, 77081, United States

Location

Psychiatric Medical Associates

Plano, Texas, 75093, United States

Location

Radiant Research, Inc.

San Antonio, Texas, 78229, United States

Location

Advanced Research Institute

Ogden, Utah, 84405, United States

Location

NeuroScience, Inc.

Herndon, Virginia, 20170, United States

Location

Summit Research Network (Seattle), LLC

Seattle, Washington, 98104, United States

Location

Klinische Forschung Berlin-Mitte GmbH

Berlin, 10117, Germany

Location

Klinische Forschung Berlin Buch GmbH

Berlin, 13125, Germany

Location

Klinische Forschung Schwerin GmbH

Schwerin, 19055, Germany

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 20, 2013
• Study Completion: September 20, 2013
• Last Updated: July 16, 2021
• Results First Posted: August 21, 2014

Record last verified: 2021-06

Locations

DE (3); US (45)