Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

NCT02009163 | Completed Phase 3 Results

• 2 other identifiers: SPD489-3462012-004457-88
• Study Type: interventional
• Target: 418
• Locations: 5 countries
• Sites: 53

Brief Summary

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.

Conditions

Binge Eating Disorder

Outcome Measures

Primary Outcomes (1)

• Time to Relapse From Date of Randomization to Endpoint of The Randomized-withdrawal Period

  Relapse status was assessed during the double-blind treatment phase and was defined as having 2 or more binge days per week for 2 consecutive weeks (14 consecutive days) prior to any visit and having an increase in Clinical Global Impressions-Severity (CGI-S) score of 2 or more points compared to the randomized-withdrawal baseline (date of relapse - date of randomization). Binge eating information was captured via a self-report paper diary. The binge diary captured the number of binges per day, total hours per day spent binging, type of binge (at mealtime or at another time other than mealtime), and a description of the binge (amounts and types of foods). Binge frequency was reviewed by the clinician with the subject to confirm reported binge episodes per day. The CGI-S was performed to rate the severity of a subject's condition using a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill).

  Visit 21 (26 weeks after randomization [Week 38] or Early Termination)

Secondary Outcomes (16)

• Change From Randomized-Withdrawal Baseline in The Number of Binge- Eating Days Per Week During The Randomized-withdrawal Period

  Randomized--withdrawal baseline (Visit 8; 12 weeks after start of open- label treatment [Week 12]), Visit 21 (26 weeks after randomization [Week 38])

• Percent of Participants Within Each Category of The Clinical Global Impression-Severity of Illness (CGI-S) Scale at Endpoint of The Randomized-withdrawal Period

  Visit 21 (26 weeks after randomization [Week 38] or Early Termination)

• Change From Randomized-Withdrawal Baseline in The Total Score of The Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) During The Randomized-withdrawal Period

  Randomized-withdrawal baseline (Visit 8; 12 weeks after start of open-label treatment [Week 12]), Visit 21 (26 weeks after randomization [Week 38])

• Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility at Endpoint of The Open-label Period

  Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)

• Percent of Participants Within Each Category of The EuroQuol Group 5--Dimension 5--Level Self--Report Questionnaire (EQ--5D--5L) For Mobility at Endpoint of The Randomized-withdrawal Period

  Visit 21 (26 weeks after randomization [Week 38] or Early Termination)

Study Arms (2)

Lisdexamfetamine dimesylate

EXPERIMENTAL

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

Drug: Lisdexamfetamine dimesylate

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Lisdexamfetamine dimesylate DRUG

SDP489 30, 50, or 70mg capsule once per day (open-label and double-blind periods)

Also known as: SPD489, LDX

Lisdexamfetamine dimesylate

Placebo OTHER

Placebo capsule once per day (double-blind period)

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, inclusive.
• 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.
• Subject is consistently able to swallow a capsule.

You may not qualify if:

• Subject has current diagnosis of bulimia nervosa or anorexia nervosa.
• Subject is receiving psychotherapy or weight loss support within the past 3 months.
• Subject has used psychostimulants to facilitate fasting or dieting within the past 6 months.
• Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease.
• Subject has abnormal thyroid function.
• Subject initiated treatment with a lipid lowering medication within the past 3 months.
• Subject has a history of moderate or severe hypertension.
• Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder.
• Subject has glaucoma.
• 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 (53)

Gulfcoast Clinical Research Center

Fort Myers, Florida, 33912, United States

Location

Innovative Clinical Research, Inc

Lauderhill, Florida, 33319, United States

Location

Compass Research LLC North Clinic

Leesburg, Florida, 34748, United States

Location

Florida Clinical Research Center, LLC

Maitland, Florida, 32751, United States

Location

Scientific Clinical Research, Inc

North Miami, Florida, 33161, 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

Goldpoint Clinical Research

Indianapolis, Indiana, 46260, United States

Location

Clinical Trials Technology, Inc

Prairie Village, Kansas, 66206, United States

Location

Cypress Medical Research Center

Wichita, Kansas, 67226, United States

Location

Louisiana Research Associates, Inc

New Orleans, Louisiana, 70114, United States

Location

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, 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

HBSA-Pacific Institute for Research & Evaluation

Albuquerque, New Mexico, 87102, United States

Location

Brooklyn Medical Institute

Brooklyn, New York, 11214, United States

Location

Wake Research Associates, LLC

Raleigh, North Carolina, 27612, United States

Location

Patient Priority Clinical Sites, LLC

Cincinnati, Ohio, 45215, United States

Location

Community Research

Cincinnati, Ohio, 45227, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

Linder Center of Hope

Mason, Ohio, 45040, United States

Location

Oregon Center for Clinical Investigations, Inc (OCCI, Inc)

Portland, Oregon, 97214, United States

Location

Oregon Center for Clinical Investigations, Inc (OCCI, Inc)

Salem, Oregon, 97301, United States

Location

Lehigh Center for Clinical Research

Allentown, Pennsylvania, 18104, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Radiant Research, Inc

Anderson, South Carolina, 29621, United States

Location

Radiant Research, Inc

Greer, South Carolina, 29650, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Clinical Neuroscience Solution, Inc

Memphis, Tennessee, 38119, United States

Location

FutureSearch Clinical Trials, LP

Austin, Texas, 78731, United States

Location

FutureSearch Trials of Dallas, LP

Dallas, Texas, 75231, United States

Location

Texas Center for Drug Development, Inc

Houston, Texas, 77081, United States

Location

Research Across America

Plano, Texas, 75093, United States

Location

Radiant Research, Inc

San Antonio, Texas, 78229, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

Summit Research Network (Seattle) LLC

Seattle, Washington, 98104, United States

Location

Anxiety and Mood Disorder Center

Mississauga, Ontario, L5< 4N4, Canada

Location

Manna Research

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

Klinische Forschung Berlin-Mitte GmbH

Berlin, 10117, Germany

Location

EMOVIS GmbH - Klinische Forschung

Berlin, 10629, Germany

Location

Klinische Forschung Dresden GmbH

Dresden, 01069, Germany

Location

Klinische Forschung Hannover-Mitte GmbH

Hanover, 30159, Germany

Location

Forschung Schwerin GmbH, Friedrichstrasse 1

Schwerin, 19055, Germany

Location

Studienzentrum Nordwest

Westerstede, 26655, Germany

Location

Hospital de la Santa Creu I Sant Pau

Barcelona, 08025, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Location

Hospital del Henares

Madrid, 28822, Spain

Location

Lakarmottagningen Ekdahl & Kronberg

Malmo, 211 52, Sweden

Location

Sofiahemmet

Stockholm, 114 86, Sweden

Location

Stockholm Center for Eating Disorders

Stockholm, 118 50, Sweden

Location

Related Publications (2)

• 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

• Hudson JI, McElroy SL, Ferreira-Cornwell MC, Radewonuk J, Gasior M. Efficacy of Lisdexamfetamine in Adults With Moderate to Severe Binge-Eating Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Sep 1;74(9):903-910. doi: 10.1001/jamapsychiatry.2017.1889.

  PMID: 28700805 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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2013
• First Posted: December 11, 2013
• Study Start: January 27, 2014
• Primary Completion: April 8, 2015
• Study Completion: April 8, 2015
• Last Updated: June 14, 2021
• Results First Posted: April 1, 2016

Record last verified: 2021-06

Locations

SE (3); DE (6); US (39); CA (2); ES (3)