Binge Eating DisorderPhase 3NCT01718509
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 48 sites in 2 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
- 390 participants
- Where
- 48 sitesin 2 countries
- Study dates
- 26 Nov 2012to 20 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
- The subject cannot be enrolled in the study before all of the following inclusion criteria (including test results) are met:
- Subject is between 18-55 years of age.
- Subject meets the following Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text Revision (DSM-IV-TR) criteria for a diagnosis of BED:
- Subject has a BED diagnosis.
- Subject's BED is of at least moderate severity with subjects reporting at least 3 binge eating days per week.
- 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.
Who cannot join
- Subjects are excluded from the study if any of the following exclusion criteria are met:
- 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.
- Subject has used psychostimulants to facilitate fasting or dieting as a part of their BED.
- Subject has a lifetime history of psychosis, mania, hypomania, dementia, or ADHD.
- Subject is considered a suicide risk, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation.
Show all 10Show fewer
- 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.
- Subject has a history of moderate or severe hypertension.
- Subject is female and pregnant or nursing.
- Subject has had bariatric surgery, lap bands, duodenal stents, or other procedures for weight loss.
Trial locations and contacts
48 sites in 2 countries.
48 sites in 2 countries
United States45 sites
Radiant Research, Inc.
Akron, Ohio, 44311
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104
NeuroTrials Research, Inc.
Atlanta, Georgia, 30342
Southern California Research, LLC
Beverly Hills, California, 90210
Boston Clinical Trials
Boston, Massachusetts, 02131
Florida Clinical Research Center, LLC
Bradenton, Florida, 34201
Patient Priority Clinical Sites, LLC
Cincinnati, Ohio, 45215
Radiant Research, Inc.
Denver, Colorado, 80239
Clinical Trials of America, Inc.
Eugene, Oregon, 97401
Potomac Grove Clinical Research Center
Gaithersburg, Maryland, 20877
Radiant Research, Inc.
Greer, South Carolina, 29650
Activmed Practices and Research
Haverhill, Massachusetts, 01830
NeuroScience, Inc.
Herndon, Virginia, 20170
Texas Center for Drug Development, Inc.
Houston, Texas, 77081
Scripps Clinical Research Services
La Jolla, California, 92037
Robert Lynn Horne, MD, LTD
Las Vegas, Nevada, 89102
Capstone Clinical Research
Libertyville, Illinois, 60048
Florida Clinical Research Center, LLC
Maitland, Florida, 32751
The Craig and Frances Lindner Center of Hope
Mason, Ohio, 45040
Sunstone Medical Research, LLC
Medford, Oregon, 97504
UMN Medical School, Dept of Psychiatry
Minneapolis, Minnesota, 55454
Bioscience Research, LLC
Mount Kisco, New York, 10549
Clinical Research Associates, Inc.
Nashville, Tennessee, 37203
Louisiana Research Associates, Inc.
New Orleans, Louisiana, 70114
CNS Clinica at the Brain Resource Center
New York, New York, 10023
Deaconess Clinic Gateway Health Center
Newburgh, Indiana, 47630
Pharmacology Research Institute
Newport Beach, California, 92660
American Medical Research
Oak Brook, Illinois, 60523
Excel Research, Inc.
Oceanside, California, 92056
Advanced Research Institute
Ogden, Utah, 84405
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806
CRI Lifetree
Philadelphia, Pennsylvania, 19139
Psychiatric Medical Associates
Plano, Texas, 75093
Oregon Center for Clinical Investigators (OCCI, Inc)
Portland, Oregon, 97210
Clinical Trials Technology, Inc.
Prairie Village, Kansas, 66206
Global Medical Inst LLC; Princeton Medical Institute
Princeton, New Jersey, 08540
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, 48307
Radiant Research, Inc.
San Antonio, Texas, 78229
PCSD - Feighner Research
San Diego, California, 92108
Summit Research Network (Seattle), LLC
Seattle, Washington, 98104
Miami Research Associates
South Miami, Florida, 33143
Scientella, LLA
St Louis, Missouri, 63141
Radiant Research, Inc.
Tucson, Arizona, 85710
Omega Medical Reserach
Warwick, Rhode Island, 02886
Adams Clinical Trials, LLC
Watertown, Massachusetts, 02472
Germany3 sites
Klinische Forschung Berlin-Mitte GmbH
Berlin, 10117
Klinische Forschung Berlin Buch GmbH
Berlin, 13125
Klinische Forschung Schwerin GmbH
Schwerin, 19055
About this study
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
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
Read the detailed description
Not Required
- 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 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.
Measured: Baseline and Visit 8 Which Spans Weeks 11/12
Secondary outcomes (19)
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.
Measured: Up to 12 weeks
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.
Measured: Up to 12 weeks
Percent Change From Baseline in Body Weight (kg) 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 up to 12 weeks
Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks
Measured: Baseline and up to 12 weeks
Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks
Measured: Baseline and up to 12 weeks
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
Measured: Up to 12 weeks
Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 Which Spans Weeks 11/12
Measured: Baseline and Visit 8 Which Spans Weeks 11/12
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.
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 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.
Measured: Baseline and week 12
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.
Measured: Baseline and up to 12 weeks
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.
Measured: Up to 12 weeks
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care
Measured: Up to 12 weeks
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities
Measured: Up to 12 weeks
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort
Measured: Up to 12 weeks
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression
Measured: Up to 12 weeks
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.
Measured: Up to 12 weeks
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.
Measured: Baseline and Week 12
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 completion20 Sep 2013
- Study completion20 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
- 390 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
- NCT01718509
- Sponsor's protocol ID
- SPD489-344
- Other IDs
- 2012-003310-14
- Status last verified
- Jun 2021
- First submitted
- 29 Oct 2012
- Last updated
- 16 Jul 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 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01718509
- Acronym / sponsor ID
- SPD489-344
- Conditions
- Binge Eating Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2012 (actual)
- Primary completion
- 20 Sep 2013 (actual)
- Study completion
- 20 Sep 2013 (actual)
- First posted
- 31 Oct 2012 (estimated)
- Results
- Posted 21 Aug 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
Detailed description
Not Required
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 (6 listed)
- The subject cannot be enrolled in the study before all of the following inclusion criteria (including test results) are met:
- Subject is between 18-55 years of age.
- Subject meets the following Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text Revision (DSM-IV-TR) criteria for a diagnosis of BED:
- Subject has a BED diagnosis.
- Subject's BED is of at least moderate severity with subjects reporting at least 3 binge eating days per week.
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.
- Subject has used psychostimulants to facilitate fasting or dieting as a part of their BED.
- Subject has a lifetime history of psychosis, mania, hypomania, dementia, or ADHD.
- Subject is considered a suicide risk, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation.
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 Which Spans Weeks 11/12
Time frame: Baseline and 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.
19 secondary outcomes
Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
Time frame: Up to 12 weeks
Percent of Participants With a 4-Week Cessation From Binge Eating
Time frame: Up to 12 weeks
Percent Change From Baseline in Body Weight (kg) 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 up to 12 weeks
Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks
Time frame: Baseline and up to 12 weeks
Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks
Time frame: Baseline and up to 12 weeks
Binge Eating Response
Time frame: Up to 12 weeks
Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 Which Spans Weeks 11/12
Time frame: Baseline and Visit 8 Which Spans 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 Up to 12 Weeks
Time frame: Baseline and up to 12 weeks
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
Change in Amphetamine Cessation Symptom Assessment (ACSA) Total Score From Baseline to Week 12.
Time frame: Baseline and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 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
48 sites in 2 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 48 sites in 2 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 6 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 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Germany. 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 Aug 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 Which Spans Weeks 11/12 (time frame: Baseline and Visit 8 Which Spans 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 NCT01718509, 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 16 Jul 2021.