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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003310-14 | EudraCT Number |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPD489 (Lisdexamfetamine dimesylate) | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPD489 (Lisdexamfetamine dimesylate) | Drug | 50 or 70 mg administered orally, once-daily for up to 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Visit 8 Which Spans Weeks 11/12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 12 weeks |
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Inclusion Criteria:
The subject cannot be enrolled in the study before all of the following inclusion criteria (including test results) are met:
Exclusion Criteria:
Subjects are excluded from the study if any of the following exclusion criteria are met:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiant Research, Inc. | Tucson | Arizona | 85710 | United States | ||
| Southern California Research, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26346638 | Result | 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. | |
| 32237290 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | PLACEBO | Administered once-daily, orally, for up to 12 weeks |
| FG001 | SPD489 | 50 or 70 mg administered orally, once-daily for up to 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Administered once-daily, orally, for 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. | Up to 12 weeks |
| Percent Change From Baseline in Body Weight (kg) at Week 12 | 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. | Baseline and week 12 |
| Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks | Baseline and up to 12 weeks |
| Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks | Baseline and up to 12 weeks |
| Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks | 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 | Up to 12 weeks |
| Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 Which Spans Weeks 11/12 | 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. | 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. | 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. | 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. | Up to 12 weeks |
| EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care | Up to 12 weeks |
| EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities | Up to 12 weeks |
| EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort | Up to 12 weeks |
| EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression | 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. | 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. | Baseline and Week 12 |
| Beverly Hills |
| California |
| 90210 |
| United States |
| Scripps Clinical Research Services | La Jolla | California | 92037 | United States |
| Pharmacology Research Institute | Newport Beach | California | 92660 | United States |
| Excel Research, Inc. | Oceanside | California | 92056 | United States |
| PCSD - Feighner Research | San Diego | California | 92108 | United States |
| Radiant Research, Inc. | Denver | Colorado | 80239 | United States |
| Florida Clinical Research Center, LLC | Bradenton | Florida | 34201 | United States |
| Florida Clinical Research Center, LLC | Maitland | Florida | 32751 | United States |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32806 | United States |
| Miami Research Associates | South Miami | Florida | 33143 | United States |
| NeuroTrials Research, Inc. | Atlanta | Georgia | 30342 | United States |
| Capstone Clinical Research | Libertyville | Illinois | 60048 | United States |
| American Medical Research | Oak Brook | Illinois | 60523 | United States |
| Deaconess Clinic Gateway Health Center | Newburgh | Indiana | 47630 | United States |
| Clinical Trials Technology, Inc. | Prairie Village | Kansas | 66206 | United States |
| Louisiana Research Associates, Inc. | New Orleans | Louisiana | 70114 | United States |
| Potomac Grove Clinical Research Center | Gaithersburg | Maryland | 20877 | United States |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | United States |
| Activmed Practices and Research | Haverhill | Massachusetts | 01830 | United States |
| Adams Clinical Trials, LLC | Watertown | Massachusetts | 02472 | United States |
| Rochester Center for Behavioral Medicine | Rochester Hills | Michigan | 48307 | United States |
| UMN Medical School, Dept of Psychiatry | Minneapolis | Minnesota | 55454 | United States |
| Scientella, LLA | St Louis | Missouri | 63141 | United States |
| Robert Lynn Horne, MD, LTD | Las Vegas | Nevada | 89102 | United States |
| Global Medical Inst LLC; Princeton Medical Institute | Princeton | New Jersey | 08540 | United States |
| Bioscience Research, LLC | Mount Kisco | New York | 10549 | United States |
| CNS Clinica at the Brain Resource Center | New York | New York | 10023 | United States |
| Radiant Research, Inc. | Akron | Ohio | 44311 | United States |
| Patient Priority Clinical Sites, LLC | Cincinnati | Ohio | 45215 | United States |
| The Craig and Frances Lindner Center of Hope | Mason | Ohio | 45040 | United States |
| Clinical Trials of America, Inc. | Eugene | Oregon | 97401 | United States |
| Sunstone Medical Research, LLC | Medford | Oregon | 97504 | United States |
| Oregon Center for Clinical Investigators (OCCI, Inc) | Portland | Oregon | 97210 | United States |
| Lehigh Center for Clinical Research | Allentown | Pennsylvania | 18104 | United States |
| CRI Lifetree | Philadelphia | Pennsylvania | 19139 | United States |
| Omega Medical Reserach | Warwick | Rhode Island | 02886 | United States |
| Radiant Research, Inc. | Greer | South Carolina | 29650 | United States |
| Clinical Research Associates, Inc. | Nashville | Tennessee | 37203 | United States |
| Texas Center for Drug Development, Inc. | Houston | Texas | 77081 | United States |
| Psychiatric Medical Associates | Plano | Texas | 75093 | United States |
| Radiant Research, Inc. | San Antonio | Texas | 78229 | United States |
| Advanced Research Institute | Ogden | Utah | 84405 | United States |
| NeuroScience, Inc. | Herndon | Virginia | 20170 | United States |
| Summit Research Network (Seattle), LLC | Seattle | Washington | 98104 | United States |
| Klinische Forschung Berlin-Mitte GmbH | Berlin | 10117 | Germany |
| Klinische Forschung Berlin Buch GmbH | Berlin | 13125 | Germany |
| Klinische Forschung Schwerin GmbH | Schwerin | 19055 | Germany |
| 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. |
| 30817099 | Derived | 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. |
| 30013816 | Derived | 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. |
| 29497297 | Derived | 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. |
| COMPLETED |
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| NOT COMPLETED |
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The Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and had at least 1 post-baseline safety assessment. 11 subjects from Site 015, 12 subjects had not been treated, and 1 subject had been treated but did not have any safety follow-up assessments were excluded from the Safety Analysis Set.
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| ID | Title | Description |
|---|---|---|
| BG000 | PLACEBO | |
| BG001 | SPD489 | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The Full Analysis Set was defined as all randomized subjects who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (i.e., number of binge days per week calculated for at least 1 week). | Posted | Least Squares Mean | Standard Error | Binge days per week | Baseline and Visit 8 Which Spans Weeks 11/12 |
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| Secondary | 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. | Full Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 12 weeks |
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| Secondary | 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. | Full Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 12 weeks |
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| Secondary | Percent Change From Baseline in Body Weight (kg) at Week 12 | Full Analysis Set. | Posted | Least Squares Mean | Standard Error | percentage change | Baseline and week 12 |
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| Secondary | 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. | Full Analysis Set. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and week 12 |
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| Secondary | Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks | Full Analysis Set. Not all subjects had data for this outcome. | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline and up to 12 weeks |
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| Secondary | Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks | Full Analysis Set. Not all subjects had data for this outcome. | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline and up to 12 weeks |
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| Secondary | Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks | Full Analysis Set. Not all subjects had data for this outcome. | Posted | Least Squares Mean | Standard Error | Percent | Baseline and up to 12 weeks |
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| Secondary | 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 | Full Analysis Set. Not all subjects had data for this outcome. | Posted | Number | percentage of participants | Up to 12 weeks |
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| Secondary | Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 Which Spans Weeks 11/12 | Full Analysis Set. | Posted | Least Squares Mean | Standard Error | Binge episodes per week | Baseline and Visit 8 Which Spans Weeks 11/12 |
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| Secondary | 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. | Full Analysis Set. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and week 12 |
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| Secondary | 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. | Full Analysis Set. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and week 12 |
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| Secondary | 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. | Full Analysis Set. Not all subjects had data for this outcome. | Posted | Least Squares Mean | Standard Error | t-scores | Baseline and up to 12 weeks |
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| Secondary | 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. | Full Analysis Set. Not all subjects had data for this outcome. | Posted | Number | percentage of participants | Up to 12 weeks |
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| Secondary | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care | Full Analysis Set. Not all subjects had data for this outcome. | Posted | Number | percentage of participants | Up to 12 weeks |
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| Secondary | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities | Full Analysis Set. Not all subjects had data for this outcome. | Posted | Number | percentage of participants | Up to 12 weeks |
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| Secondary | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort | Full Analysis Set. Not all subjects had data for this outcome. | Posted | Number | percentage of participants | Up to 12 weeks |
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| Secondary | EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression | Full Analysis Set. Not all subjects had data for this outcome. | Posted | Number | percentage of participants | Up to 12 weeks |
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| Secondary | 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. | For this Outcome Measure the Safety Analysis Set is defined as all randomized subjects who took at least 1 dose of investigational product and who had at least 1 post-baseline safety assessment completed, and responded to the relevant questions for the C-SSRS. All subjects from Site 015 were excluded from the Safety Analysis Set. | Posted | Number | participants | Up to 12 weeks |
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| Secondary | 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. | Safety Analysis Set who completed ACSC at Baseline & Week 12 Visits. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 12 |
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Not provided
The Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and had at least 1 follow-up safety assessment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PLACEBO | Administered once-daily, orally, for up to 12 weeks | 2 | 185 | 43 | 185 | ||
| EG001 | SPD489 | 50 or 70 mg administered orally, once-daily for up to 12 weeks | 1 | 181 | 100 | 181 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fibula fracture | Injury, poisoning and procedural complications |
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| Lumbar vertebral fracture | Injury, poisoning and procedural complications |
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| Syncope | Nervous system disorders |
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| Agitation | Psychiatric disorders |
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| Anxiety | Psychiatric disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders |
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| Diarrhoea | Gastrointestinal disorders |
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| Dry mouth | Gastrointestinal disorders |
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| Nausea | Gastrointestinal disorders |
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| Fatigue | General disorders |
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| Feeling jittery | General disorders |
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| Decreased appetite | Metabolism and nutrition disorders |
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| Headache | Nervous system disorders |
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| Insomnia | Psychiatric disorders |
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If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
| ID | Term |
|---|---|
| D056912 | Binge-Eating Disorder |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069478 | Lisdexamfetamine Dimesylate |
| ID | Term |
|---|---|
| D003913 | Dextroamphetamine |
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
Not provided
Not provided
| >= 40 years |
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| Male |
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| UNITED STATES |
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