Binge Eating DisorderPhase 3NCT01718483
SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder
A Phase 3 study testing SPD489 (Lisdexamfetamine dimesylate) in people with Binge Eating Disorder, run by Shire at 50 sites in 4 countries.
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)… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Binge Eating Disorder
- What is being tested?
- SPD489 (Lisdexamfetamine dimesylate)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 383 participants
- Where
- 50 sitesin 4 countries
- Study dates
- 26 Nov 2012to 25 Sep 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject is between 18-55 years of age.
- 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.
- 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.
- Female subjects must have a negative serum B HCG pregnancy test and a negative urine pregnancy test.
Who cannot join
- Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa.
- Subject is receiving psychotherapy (eg, supportive psychotherapy, cognitive behavior therapy, interpersonal therapy) or weight loss support (eg, Weight Watchers) for BED within 3 months.
- Subject has used psychostimulants to facilitate fasting or dieting as a part of their BED within 6 months.
- Subject has a lifetime history of psychosis, mania, hypomania, dementia, or ADHD.
- 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.
- 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.
Show all 10Show fewer
- Subject has recently initiated treatment with a lipid-lowering medication (within the past 3 months).
- Subject has a history of moderate or severe hypertension.
- Subject is female and pregnant or nursing.
- Subjects who have had bariatric surgery, lap bands, duodenal stents, or other procedures for weight loss.
Trial locations and contacts
50 sites in 4 countries.
50 sites in 4 countries
United States43 sites
Pacific Research for Research and Evaluation
Albuquerque, New Mexico, 87102
Radiant Research, Inc.
Anderson, South Carolina, 29621
Future Search Trials
Austin, Texas, 78731
Northwest Clinical Research Center
Bellevue, Washington, 98007
McLean Hospital
Belmont, Massachusetts, 02478
Birmingham Research Group
Birmingham, Alabama, 35216
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, 22911
Uptown Research Institute
Chicago, Illinois, 60640
Community Research
Cincinnati, Ohio, 45227
Trimed Clinical Trials
Corona, California, 92880
Futuresearch Trials of Dallas, L.P.
Dallas, Texas, 75231
Midwest Clinical Research Center, LLC
Dayton, Ohio, 45417
Western Affiliated Research Institute, Inc.
Denver, Colorado, 80209
Pharmacology Research Institute
Encino, California, 91316
Gulfcoast Clinical Research
Fort Myers, Florida, 33912
Alexian Brothers Behavioral Health Hospital
Hoffman Estates, Illinois, 60169
Goldpoint Clinical Research, LLC
Indianapolis, Indiana, 46260
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256
The Clinical Trials Center, LLC
Jenkintown, Pennsylvania, 19046
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, 89128
Fidelity Clinical Research, Inc.
Lauderhill, Florida, 33319
Compass Research LLC
Leesburg, Florida, 34748
Clinical Study Centers, LLC
Little Rock, Arkansas, 72211
Pharmacology Research Institute
Los Alamitos, California, 90720
Suburban Research Associates
Media, Pennsylvania, 19063
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119
North Star Medical Research
Middleburg Heights, Ohio, 44130
Dean Foundation for Health, Research and Educations, Inc.
Middleton, Wisconsin, 53562
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Radiant Research, Inc.
Murray, Utah, 84123
AMR Baber Research, Inc.
Naperville, Illinois, 60563
Scientific Clinical Research Inc.
North Miami, Florida, 33161
Pacific Research Partners, LLC
Oakland, California, 94812
IPS Research Company
Oklahoma City, Oklahoma, 73103
Clinical Trials Research Services, LLC
Pittsburgh, Pennsylvania, 15206
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
Alliance Research Group
Richmond, Virginia, 23230
St. Charles Psychiatric Associates/Midwest Research Group
Saint Charles, Missouri, 63304
Oregon Center for Clinical Investigations, Inc.
Salem, Oregon, 97301
Research Across America
Santa Ana, California, 92705
Cypress Medical Research Center, LLC
Wichita, Kansas, 67226
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309
Neuropsychiatric Associates, LLC
Woodstock, Vermont, 05091
Germany3 sites
Ernovis GmbH
Berlin, 10629
Klinische Forschung Dresden GmbH
Dresden, 01069
Studienzentrum Nordwest, Gemeinschaftspraxis
Westerstede, 26655
Sweden3 sites
Lakarmottagning Ekdahl & Kronberg
Malmö, 22152
Sophiahemmet
Stockholm, 11486
Stockholm Center for Eating Disorders
Stockholm, 11850
About this study
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
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
- Conditions
- Binge Eating Disorder
- Being tested
- SPD489 (Lisdexamfetamine dimesylate), Placebo
- Medical subject headings
- Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPD489 (Lisdexamfetamine dimesylate)Drug
Also called Vyvanse, Venvanse, LDX
50 or 70 mg administered orally, once-daily for up to 12 weeks
PlaceboDrug
Administered once-daily, orally, for up to 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| SPD489 (Lisdexamfetamine dimesylate) | Experimental | Not described Receives: Drug: SPD489 (Lisdexamfetamine dimesylate) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Number of Binge Days Per Week at Visit 8 (Weeks 11-12)
Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on participant binge diary.
Measured: Baseline and Visit 8 (Weeks 11-12)
Secondary outcomes (19)
Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
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.
Measured: Up to 12 weeks
Percentage 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.
Measured: Up to 12 weeks
Percent Change From Baseline in Body Weight at Week 12
Measured: Baseline and Week 12
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.
Measured: Baseline and Week 12
Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks
Measured: Baseline and Week 12/Early termination (ET)
Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks
Measured: Baseline and Week 12/ET
Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks
Measured: Baseline and Week 12/ET
Binge Eating Response
Response is based on the reduction in the number of binge eating episodes. Percentage of participants with response was reported. 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.
Measured: Week 12/ET
Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 (Weeks 11-12)
Measured: Baseline and Visit 8 (Weeks 11-12)
Change From Baseline in Eating Inventory Scores at Week 12
The Eating Inventory also known as the Three-Factor Eating Questionnaire is a 51-item self-reported questionnaire intended to assess 3 dimensions of eating behavior. 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.
Measured: Baseline and Week 12
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 participant has greater control over eating behavior and 4 denoting that a participant 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.
Measured: Baseline and Week 12
Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Week 12
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. Participants 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.
Measured: Baseline and Week 12
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. Percentage of participants with various mobility conditions were reported.
Measured: Up to 12 weeks
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care
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. Percentage of participants with various self-care conditions were reported.
Measured: Up to 12 weeks
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities
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. Percentage of participants with various usual activities conditions were reported.
Measured: Up to 12 weeks
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort
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. Percentage of participants with various pain/discomfort conditions were reported.
Measured: Up to 12 weeks
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression
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. Percentage of participants with various anxiety/depression conditions were reported.
Measured: Up to 12 weeks
Columbia-Suicide Severity Rating Scale (C-SSRS)
C-SSRS is a semi-structured interview that captures the occurrence, 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. Number of participants with suicidal ideation and suicidal behavior were reported.
Measured: Up to 12 weeks
Amphetamine Cessation Symptom Assessment (ACSA) Total Score
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.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study start26 Nov 2012
- Primary completion25 Sep 2013
- Study completion25 Sep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Binge Eating DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 383 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718483
- Sponsor's protocol ID
- SPD489-343
- Other IDs
- 2012-003309-91
- Status last verified
- May 2021
- First submitted
- 29 Oct 2012
- Last updated
- 8 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 26346638Robertson 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.
PubMed 32237290Kornstein 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.
PubMed 30817099Sheehan 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.
PubMed 30013816Citrome 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.
PubMed 29497297
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01718483
- Acronym / sponsor ID
- SPD489-343
- Conditions
- Binge Eating Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 383 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2012 (actual)
- Primary completion
- 25 Sep 2013 (actual)
- Study completion
- 25 Sep 2013 (actual)
- First posted
- 31 Oct 2012 (estimated)
- Results
- Posted 21 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPD489 (Lisdexamfetamine dimesylate) | Experimental | Drug: SPD489 (Lisdexamfetamine dimesylate) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject is between 18-55 years of age.
- 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.
Key exclusion criteria (10 listed)
- Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa.
- Subject is receiving psychotherapy (eg, supportive psychotherapy, cognitive behavior therapy, interpersonal therapy) or weight loss support (eg, Weight Watchers) for BED within 3 months.
- Subject has used psychostimulants to facilitate fasting or dieting as a part of their BED within 6 months.
- Subject has a lifetime history of psychosis, mania, hypomania, dementia, or ADHD.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPD489 (Lisdexamfetamine dimesylate)Also: Vyvanse, Venvanse, LDX50 or 70 mg administered orally, once-daily for up to 12 weeks | Drug | SPD489 (Lisdexamfetamine dimesylate) |
| PlaceboAdministered once-daily, orally, for up to 12 weeks | Drug | Placebo |
Primary outcome
Change From Baseline in the Number of Binge Days Per Week at Visit 8 (Weeks 11-12)
Time frame: Baseline and Visit 8 (Weeks 11-12)
Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on participant binge diary.
19 secondary outcomes
Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
Time frame: Up to 12 weeks
Percentage of Participants With a 4-Week Cessation From Binge Eating
Time frame: Up to 12 weeks
Percent Change From Baseline in Body Weight at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks
Time frame: Baseline and Week 12/Early termination (ET)
Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks
Time frame: Baseline and Week 12/ET
Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks
Time frame: Baseline and Week 12/ET
Binge Eating Response
Time frame: Week 12/ET
Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 (Weeks 11-12)
Time frame: Baseline and Visit 8 (Weeks 11-12)
Change From Baseline in Eating Inventory Scores at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Binge Eating Scale (BES) Score at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Week 12
Time frame: Baseline and Week 12
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility
Time frame: Up to 12 weeks
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care
Time frame: Up to 12 weeks
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities
Time frame: Up to 12 weeks
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort
Time frame: Up to 12 weeks
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression
Time frame: Up to 12 weeks
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to 12 weeks
Amphetamine Cessation Symptom Assessment (ACSA) Total Score
Time frame: Up to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26346638McElroy 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.
- Derived from this study: PubMed 32237290Robertson 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.
- Derived from this study: PubMed 30817099Kornstein 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.
- Derived from this study: PubMed 30013816Sheehan 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.
- Derived from this study: PubMed 29497297Citrome 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
50 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SPD489 (Lisdexamfetamine dimesylate) in people with Binge Eating Disorder, run by Shire at 50 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States, Germany, Sweden, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the Number of Binge Days Per Week at Visit 8 (Weeks 11-12) (time frame: Baseline and Visit 8 (Weeks 11-12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01718483, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.