Clinical trial NCT01718483: SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder
Official title: The SPD489-343, 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Binge Eating Disorder
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2012-10-31
Enrollment: 383
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Change From Baseline in the Number of Binge Days Per Week at Visit 8 (Weeks 11-12)
timeFrame: Baseline and Visit 8 (Weeks 11-12)
Secondary outcomes:
measure: Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
timeFrame: Up to 12 weeks
measure: Percentage of Participants With a 4-Week Cessation From Binge Eating
timeFrame: Up to 12 weeks
measure: Percent Change From Baseline in Body Weight at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks
timeFrame: Baseline and Week 12/Early termination (ET)
measure: Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks
timeFrame: Baseline and Week 12/ET
measure: Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks
timeFrame: Baseline and Week 12/ET
measure: Binge Eating Response
timeFrame: Week 12/ET
measure: Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 (Weeks 11-12)
timeFrame: Baseline and Visit 8 (Weeks 11-12)
measure: Change From Baseline in Eating Inventory Scores at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Binge Eating Scale (BES) Score at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Week 12
timeFrame: Baseline and Week 12
measure: EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility
timeFrame: Up to 12 weeks
measure: EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care
timeFrame: Up to 12 weeks
measure: EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities
timeFrame: Up to 12 weeks
measure: EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort
timeFrame: Up to 12 weeks
measure: EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression
timeFrame: Up to 12 weeks
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Up to 12 weeks
measure: Amphetamine Cessation Symptom Assessment (ACSA) Total Score
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Research Group
state: Alabama
city: Little Rock
country: United States
facility: Clinical Study Centers, LLC
state: Arkansas
city: Corona
country: United States
facility: Trimed Clinical Trials
state: California
city: Encino
country: United States
facility: Pharmacology Research Institute
state: California
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute
state: California
city: Oakland
country: United States
facility: Pacific Research Partners, LLC
state: California
city: Santa Ana
country: United States
facility: Research Across America
state: California
city: Denver
country: United States
facility: Western Affiliated Research Institute, Inc.
state: Colorado
city: Fort Myers
country: United States
facility: Gulfcoast Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Lauderhill
country: United States
facility: Fidelity Clinical Research, Inc.
state: Florida
city: Leesburg
country: United States
facility: Compass Research LLC
state: Florida
city: North Miami
country: United States
facility: Scientific Clinical Research Inc.
state: Florida
city: Chicago
country: United States
facility: Uptown Research Institute
state: Illinois
city: Hoffman Estates
country: United States
facility: Alexian Brothers Behavioral Health Hospital
state: Illinois
city: Naperville
country: United States
facility: AMR Baber Research, Inc.
state: Illinois
city: Indianapolis
country: United States
facility: Goldpoint Clinical Research, LLC
state: Indiana
city: Wichita
country: United States
facility: Cypress Medical Research Center, LLC
state: Kansas
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
city: Saint Charles
country: United States
facility: St. Charles Psychiatric Associates/Midwest Research Group
state: Missouri
city: Las Vegas
country: United States
facility: Center for Psychiatry and Behavioral Medicine, Inc.
state: Nevada
city: Albuquerque
country: United States
facility: Pacific Research for Research and Evaluation
state: New Mexico
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center, LLC
state: Ohio
city: Middleburg Heights
country: United States
facility: North Star Medical Research
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Salem
country: United States
facility: Oregon Center for Clinical Investigations, Inc.
state: Oregon
city: Jenkintown
country: United States
facility: The Clinical Trials Center, LLC
state: Pennsylvania
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Clinical Trials Research Services, LLC
state: Pennsylvania
city: Anderson
country: United States
facility: Radiant Research, Inc.
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Austin
country: United States
facility: Future Search Trials
state: Texas
city: Dallas
country: United States
facility: Futuresearch Trials of Dallas, L.P.
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Clinical Drug Trials
state: Texas
city: Murray
country: United States
facility: Radiant Research, Inc.
state: Utah
city: Woodstock
country: United States
facility: Neuropsychiatric Associates, LLC
state: Vermont
city: Charlottesville
country: United States
facility: Charlottesville Medical Research Center, LLC
state: Virginia
city: Richmond
country: United States
facility: Alliance Research Group
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Middleton
country: United States
facility: Dean Foundation for Health, Research and Educations, Inc.
state: Wisconsin
city: Berlin
country: Germany
facility: Ernovis GmbH
city: Dresden
country: Germany
facility: Klinische Forschung Dresden GmbH
city: Westerstede
country: Germany
facility: Studienzentrum Nordwest, Gemeinschaftspraxis
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Malmo
country: Sweden
facility: Lakarmottagning Ekdahl & Kronberg
city: Stockholm
country: Sweden
facility: Sophiahemmet
city: Stockholm
country: Sweden
facility: Stockholm Center for Eating Disorders
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.