Clinical trial NCT02009163: Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder
Official title: A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized-withdrawal Study to Evaluate the Maintenance of Efficacy 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: 2013-12-11
Enrollment: 418
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: 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.


Eligibility criteria: Inclusion Criteria:

1. Subject is between 18-55 years of age, inclusive.
2. 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.
3. Subject is consistently able to swallow a capsule.

Exclusion Criteria:

1. Subject has current diagnosis of bulimia nervosa or anorexia nervosa.
2. Subject is receiving psychotherapy or weight loss support within the past 3 months.
3. Subject has used psychostimulants to facilitate fasting or dieting within the past 6 months.
4. Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease.
5. Subject has abnormal thyroid function.
6. Subject initiated treatment with a lipid lowering medication within the past 3 months.
7. Subject has a history of moderate or severe hypertension.
8. Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder.
9. Subject has glaucoma.
10. Subject is female and pregnant or nursing.
11. Subjects who have had bariatric surgery, lap bands, duodenal stents, or other procedures for weight loss.

Primary outcomes:
measure: Time to Relapse From Date of Randomization to Endpoint of The Randomized-withdrawal Period
timeFrame: Visit 21 (26 weeks after randomization [Week 38] or Early Termination)
Secondary outcomes:
measure: Change From Randomized-Withdrawal Baseline in The Number of Binge- Eating Days Per Week During The Randomized-withdrawal Period
timeFrame: Randomized--withdrawal baseline (Visit 8; 12 weeks after start of open- label treatment [Week 12]), Visit 21 (26 weeks after randomization [Week 38])
measure: Percent of Participants Within Each Category of The Clinical Global Impression-Severity of Illness (CGI-S) Scale at Endpoint of The Randomized-withdrawal Period
timeFrame: Visit 21 (26 weeks after randomization [Week 38] or Early Termination)
measure: 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
timeFrame: Randomized-withdrawal baseline (Visit 8; 12 weeks after start of open-label treatment [Week 12]), Visit 21 (26 weeks after randomization [Week 38])
measure: 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
timeFrame: Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)
measure: 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
timeFrame: Visit 21 (26 weeks after randomization [Week 38] or Early Termination)
measure: Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care at Endpoint of The Open-label Period
timeFrame: Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)
measure: Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care at Endpoint of The Randomized-withdrawal Period
timeFrame: Visit 21 (26 weeks after randomization [Week 38] or Early Termination)
measure: Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities at Endpoint of The Open-label Period
timeFrame: Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)
measure: Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities at Endpoint of The Randomized-withdrawal Period
timeFrame: Visit 21 (26 weeks after randomization [Week 38] or Early Termination)
measure: Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort at Endpoint of The Open-label Period
timeFrame: Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)
measure: Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort at Endpoint of The Randomized-withdrawal Period
timeFrame: Visit 21 (26 weeks after randomization [Week 38] or Early Termination)
measure: Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety And Depression at Endpoint of The Open-label Period
timeFrame: Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)
measure: Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety And Depression at Endpoint of The Randomized-withdrawal Period
timeFrame: Visit 21 (26 weeks after randomization [Week 38] or Early Termination)
measure: Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS) at Endpoint of The Open-label Period
timeFrame: Visit 8 (12 weeks after start of open-label treatment [Week 12])
measure: Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS) at Endpoint of The Randomized-withdrawal Period
timeFrame: Visit 21 (26 weeks after randomization [Week 38] or Early Termination)
measure: Total Scores For The Amphetamine Cessation Symptom Assessment (ACSA) Scale During Follow-up
timeFrame: Visit 21 (26 weeks after randomization [Week 38] or Early Termination) and Visit 22 (7 days post last dose)
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: Gulfcoast Clinical Research Center
state: Florida
city: Lauderhill
country: United States
facility: Innovative Clinical Research, Inc
state: Florida
city: Leesburg
country: United States
facility: Compass Research LLC North Clinic
state: Florida
city: Maitland
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: North Miami
country: United States
facility: Scientific Clinical Research, Inc
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: Indianapolis
country: United States
facility: Goldpoint Clinical Research
state: Indiana
city: Prairie Village
country: United States
facility: Clinical Trials Technology, Inc
state: Kansas
city: Wichita
country: United States
facility: Cypress Medical Research Center
state: Kansas
city: New Orleans
country: United States
facility: Louisiana Research Associates, Inc
state: Louisiana
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Clinical Trials
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: Albuquerque
country: United States
facility: HBSA-Pacific Institute for Research & Evaluation
state: New Mexico
city: Brooklyn
country: United States
facility: Brooklyn Medical Institute
state: New York
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: Patient Priority Clinical Sites, LLC
state: Ohio
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Mason
country: United States
facility: Linder Center of Hope
state: Ohio
city: Portland
country: United States
facility: Oregon Center for Clinical Investigations, Inc (OCCI, Inc)
state: Oregon
city: Salem
country: United States
facility: Oregon Center for Clinical Investigations, Inc (OCCI, Inc)
state: Oregon
city: Allentown
country: United States
facility: Lehigh Center for Clinical Research
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Anderson
country: United States
facility: Radiant Research, Inc
state: South Carolina
city: Greer
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 Solution, Inc
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Clinical Trials, LP
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, LP
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development, Inc
state: Texas
city: Plano
country: United States
facility: Research Across America
state: Texas
city: San Antonio
country: United States
facility: Radiant Research, Inc
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: Summit Research Network (Seattle) LLC
state: Washington
city: Mississauga
country: Canada
facility: Anxiety and Mood Disorder Center
state: Ontario
city: Pointe Claire
country: Canada
facility: Manna Research
state: Quebec
city: Berlin
country: Germany
facility: Klinische Forschung Berlin-Mitte GmbH
city: Berlin
country: Germany
facility: EMOVIS GmbH - Klinische Forschung
city: Dresden
country: Germany
facility: Klinische Forschung Dresden GmbH
city: Hannover
country: Germany
facility: Klinische Forschung Hannover-Mitte GmbH
city: Schwerin
country: Germany
facility: Forschung Schwerin GmbH, Friedrichstrasse 1
city: Westerstede
country: Germany
facility: Studienzentrum Nordwest
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu I Sant Pau
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital del Henares
city: Malmo
country: Sweden
facility: Lakarmottagningen Ekdahl & Kronberg
city: Stockholm
country: Sweden
facility: Sofiahemmet
city: Stockholm
country: Sweden
facility: Stockholm Center for Eating Disorders
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
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: 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.