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

Binge Eating Disorder Clinical Trial

Official title:

The SPD489-344, Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-optimization Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01718509
• Other study ID #: SPD489-344
• Secondary ID: 2012-003310-14
• Status: Completed
• Phase: Phase 3
• Start date: November 26, 2012
• Est. completion date: September 20, 2013

Study information

• Verified date: June 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Not Required

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. completion date: September 20, 2013
• Est. primary completion date: September 20, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

The subject cannot be enrolled in the study before all of the following inclusion criteria (including test results) are met:

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

2. Subject meets the following Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text Revision (DSM-IV-TR) criteria for a diagnosis of BED:

3. Subject has a BED diagnosis.

4. Subject's BED is of at least moderate severity with subjects reporting at least 3 binge eating days per week.

5. 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.

Exclusion Criteria:

Subjects are excluded from the study if any of the following exclusion criteria are met:

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.

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

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

5. Subject is considered a suicide risk, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation.

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 a history of moderate or severe hypertension.

8. Subject is female and pregnant or nursing.

9. Subject has had bariatric surgery, lap bands, duodenal stents, or other procedures for weight loss.

Related Conditions & MeSH terms

• Binge Eating Disorder
• Binge-Eating Disorder
• Bulimia
• Feeding and Eating Disorders

Intervention

Drug:
• SPD489 (Lisdexamfetamine dimesylate)
50 or 70 mg administered orally, once-daily for up to 12 weeks
• Placebo
Administered once-daily, orally, for up to 12 weeks

Locations

Country	Name	City	State
Germany	Klinische Forschung Berlin Buch GmbH	Berlin
Germany	Klinische Forschung Berlin-Mitte GmbH	Berlin
Germany	Klinische Forschung Schwerin GmbH	Schwerin
United States	Radiant Research, Inc.	Akron	Ohio
United States	Lehigh Center for Clinical Research	Allentown	Pennsylvania
United States	NeuroTrials Research, Inc.	Atlanta	Georgia
United States	Southern California Research, LLC	Beverly Hills	California
United States	Boston Clinical Trials	Boston	Massachusetts
United States	Florida Clinical Research Center, LLC	Bradenton	Florida
United States	Patient Priority Clinical Sites, LLC	Cincinnati	Ohio
United States	Radiant Research, Inc.	Denver	Colorado
United States	Clinical Trials of America, Inc.	Eugene	Oregon
United States	Potomac Grove Clinical Research Center	Gaithersburg	Maryland
United States	Radiant Research, Inc.	Greer	South Carolina
United States	Activmed Practices and Research	Haverhill	Massachusetts
United States	NeuroScience, Inc.	Herndon	Virginia
United States	Texas Center for Drug Development, Inc.	Houston	Texas
United States	Scripps Clinical Research Services	La Jolla	California
United States	Robert Lynn Horne, MD, LTD	Las Vegas	Nevada
United States	Capstone Clinical Research	Libertyville	Illinois
United States	Florida Clinical Research Center, LLC	Maitland	Florida
United States	The Craig and Frances Lindner Center of Hope	Mason	Ohio
United States	Sunstone Medical Research, LLC	Medford	Oregon
United States	UMN Medical School, Dept of Psychiatry	Minneapolis	Minnesota
United States	Bioscience Research, LLC	Mount Kisco	New York
United States	Clinical Research Associates, Inc.	Nashville	Tennessee
United States	Louisiana Research Associates, Inc.	New Orleans	Louisiana
United States	CNS Clinica at the Brain Resource Center	New York	New York
United States	Deaconess Clinic Gateway Health Center	Newburgh	Indiana
United States	Pharmacology Research Institute	Newport Beach	California
United States	American Medical Research	Oak Brook	Illinois
United States	Excel Research, Inc.	Oceanside	California
United States	Advanced Research Institute	Ogden	Utah
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	CRI Lifetree	Philadelphia	Pennsylvania
United States	Psychiatric Medical Associates	Plano	Texas
United States	Oregon Center for Clinical Investigators (OCCI, Inc)	Portland	Oregon
United States	Clinical Trials Technology, Inc.	Prairie Village	Kansas
United States	Global Medical Inst LLC; Princeton Medical Institute	Princeton	New Jersey
United States	Rochester Center for Behavioral Medicine	Rochester Hills	Michigan
United States	Scientella, LLA	Saint Louis	Missouri
United States	Radiant Research, Inc.	San Antonio	Texas
United States	PCSD - Feighner Research	San Diego	California
United States	Summit Research Network (Seattle), LLC	Seattle	Washington
United States	Miami Research Associates	South Miami	Florida
United States	Radiant Research, Inc.	Tucson	Arizona
United States	Omega Medical Reserach	Warwick	Rhode Island
United States	Adams Clinical Trials, LLC	Watertown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Countries where clinical trial is conducted

United States,  Germany, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores	Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.	Up to 12 weeks
Secondary	Percent of Participants With a 4-Week Cessation From Binge Eating	4-week cessation from binge eating is defined as no binge eating episodes for 28 consecutive days prior to the last study visit.	Up to 12 weeks
Secondary	Percent Change From Baseline in Body Weight (kg) at Week 12		Baseline and week 12
Secondary	Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12	The Y-BOCS-BE measures the obsession of binge-eating thoughts and compulsiveness of binge-eating behaviors. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). Total scores range from 0 to 40. Reduction in total score indicates improvement.	Baseline and week 12
Secondary	Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks		Baseline and up to 12 weeks
Secondary	Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks		Baseline and up to 12 weeks
Secondary	Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks		Baseline and up to 12 weeks
Secondary	Binge Eating Response	Response is based on the reduction in the number of binge eating episodes. Responses were categorized as follows: -1-week Cessation = 100% reduction in binge episodes during the preceding 7 days -Marked Reduction = 99% to 75% reduction during the time since the previous visit -Moderate Reduction = 74% to 50% reduction during the time since the previous visit -Negative to Minimal Reduction = <50% reduction during the time since the previous visit	Up to 12 weeks
Secondary	Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 Which Spans Weeks 11/12		Baseline and Visit 8 Which Spans Weeks 11/12
Secondary	Change From Baseline in Eating Inventory Scores at Week 12	There are 36 true/false items, 14 items on a 4-point Likert scale (1=eat rarely to 4=always), and 1 item on a 6-point Likert scale (1=eat whatever you want to 6=constantly limiting food intake). Cognitive Restraint score ranges from 0-21. Hunger score ranges from 0-14. Disinhibition score ranges from 0-16. Higher scores denote higher levels of restrained eating, disinhibited eating and predisposition to hunger.	Baseline and week 12
Secondary	Change From Baseline in Binge Eating Scale (BES) Score at Week 12	The BES is a self-reported questionnaire containing 16 items designed to assess behavioral, affective, and attitudinal components of the subjective experience of binge eating. Each item is assessed based on 1 of 4 responses, with 1 denoting that a subject has greater control over eating behavior and 4 denoting that a subject had less control over eating behavior. A total score (sum of the 16 items) may range from 16-64. A lower score indicates greater control over eating behavior.	Baseline and week 12
Secondary	Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Up to 12 Weeks	The FrSBe is a 46-item self-rating scale designed to measure the neurobehavioral traits associated with the 3 primary regions of the prefrontal cortex. Subjects were asked to indicate the frequency with which they have engaged in certain behaviors using a rating scale from "1" (almost never) to "5" (almost always). Summary scores were calculated and converted to t-score. A decrease from baseline in FrSBe total score represents improvement.	Baseline and up to 12 weeks
Secondary	EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility	Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.	Up to 12 weeks
Secondary	EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care		Up to 12 weeks
Secondary	EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities		Up to 12 weeks
Secondary	EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort		Up to 12 weeks
Secondary	EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression		Up to 12 weeks
Secondary	Columbia-Suicide Severity Rating Scale (C-SSRS)	C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.	Up to 12 weeks
Secondary	Change in Amphetamine Cessation Symptom Assessment (ACSA) Total Score From Baseline to Week 12.	ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity. Calculated as Baseline (Day 0) - Week 12 ACSA scores.	Baseline and Week 12