Clinical trial NCT01718509: SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Binge Eating Disorder
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2012-10-31
Enrollment: 390
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

Detailed description: Not Required

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in the Number of Binge Days Per Week at Visit 8 Which Spans Weeks 11/12
timeFrame: Baseline and Visit 8 Which Spans Weeks 11/12
Secondary outcomes:
measure: Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
timeFrame: Up to 12 weeks
measure: Percent of Participants With a 4-Week Cessation From Binge Eating
timeFrame: Up to 12 weeks
measure: Percent Change From Baseline in Body Weight (kg) 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 up to 12 weeks
measure: Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks
timeFrame: Baseline and up to 12 weeks
measure: Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks
timeFrame: Baseline and up to 12 weeks
measure: Binge Eating Response
timeFrame: Up to 12 weeks
measure: Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 Which Spans Weeks 11/12
timeFrame: Baseline and Visit 8 Which Spans 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 Up to 12 Weeks
timeFrame: Baseline and up to 12 weeks
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: Change in Amphetamine Cessation Symptom Assessment (ACSA) Total Score From Baseline to Week 12.
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Radiant Research, Inc.
state: Arizona
city: Beverly Hills
country: United States
facility: Southern California Research, LLC
state: California
city: La Jolla
country: United States
facility: Scripps Clinical Research Services
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute
state: California
city: Oceanside
country: United States
facility: Excel Research, Inc.
state: California
city: San Diego
country: United States
facility: PCSD - Feighner Research
state: California
city: Denver
country: United States
facility: Radiant Research, Inc.
state: Colorado
city: Bradenton
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Maitland
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Atlanta
country: United States
facility: NeuroTrials Research, Inc.
state: Georgia
city: Libertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Oak Brook
country: United States
facility: American Medical Research
state: Illinois
city: Newburgh
country: United States
facility: Deaconess Clinic Gateway Health Center
state: Indiana
city: Prairie Village
country: United States
facility: Clinical Trials Technology, Inc.
state: Kansas
city: New Orleans
country: United States
facility: Louisiana Research Associates, Inc.
state: Louisiana
city: Gaithersburg
country: United States
facility: Potomac Grove Clinical Research Center
state: Maryland
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Haverhill
country: United States
facility: Activmed Practices and Research
state: Massachusetts
city: Watertown
country: United States
facility: Adams Clinical Trials, LLC
state: Massachusetts
city: Rochester Hills
country: United States
facility: Rochester Center for Behavioral Medicine
state: Michigan
city: Minneapolis
country: United States
facility: UMN Medical School, Dept of Psychiatry
state: Minnesota
city: Saint Louis
country: United States
facility: Scientella, LLA
state: Missouri
city: Las Vegas
country: United States
facility: Robert Lynn Horne, MD, LTD
state: Nevada
city: Princeton
country: United States
facility: Global Medical Inst LLC; Princeton Medical Institute
state: New Jersey
city: Mount Kisco
country: United States
facility: Bioscience Research, LLC
state: New York
city: New York
country: United States
facility: CNS Clinica at the Brain Resource Center
state: New York
city: Akron
country: United States
facility: Radiant Research, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Patient Priority Clinical Sites, LLC
state: Ohio
city: Mason
country: United States
facility: The Craig and Frances Lindner Center of Hope
state: Ohio
city: Eugene
country: United States
facility: Clinical Trials of America, Inc.
state: Oregon
city: Medford
country: United States
facility: Sunstone Medical Research, LLC
state: Oregon
city: Portland
country: United States
facility: Oregon Center for Clinical Investigators (OCCI, Inc)
state: Oregon
city: Allentown
country: United States
facility: Lehigh Center for Clinical Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: CRI Lifetree
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Reserach
state: Rhode Island
city: Greer
country: United States
facility: Radiant Research, Inc.
state: South Carolina
city: Nashville
country: United States
facility: Clinical Research Associates, Inc.
state: Tennessee
city: Houston
country: United States
facility: Texas Center for Drug Development, Inc.
state: Texas
city: Plano
country: United States
facility: Psychiatric Medical Associates
state: Texas
city: San Antonio
country: United States
facility: Radiant Research, Inc.
state: Texas
city: Ogden
country: United States
facility: Advanced Research Institute
state: Utah
city: Herndon
country: United States
facility: NeuroScience, Inc.
state: Virginia
city: Seattle
country: United States
facility: Summit Research Network (Seattle), LLC
state: Washington
city: Berlin
country: Germany
facility: Klinische Forschung Berlin-Mitte GmbH
city: Berlin
country: Germany
facility: Klinische Forschung Berlin Buch GmbH
city: Schwerin
country: Germany
facility: Klinische Forschung Schwerin GmbH
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.