<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01718483</url>
  </required_header>
  <id_info>
    <org_study_id>SPD489-343</org_study_id>
    <secondary_id>2012-003309-91</secondary_id>
    <nct_id>NCT01718483</nct_id>
  </id_info>
  <brief_title>SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shire</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the study is to demonstrate the efficacy of SPD489 compared with&#xD;
      placebo in adults (18 55 years of age inclusive) with moderate to severe Binge Eating&#xD;
      Disorder at Visit 8 (Weeks 11 and 12) as measured by the number of binge days (defined as&#xD;
      days during which at least 1 binge episode occurs) per week as assessed by clinical interview&#xD;
      based on subject diary&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 26, 2012</start_date>
  <completion_date type="Actual">September 25, 2013</completion_date>
  <primary_completion_date type="Actual">September 25, 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in the Number of Binge Days Per Week at Visit 8 (Weeks 11-12)</measure>
    <time_frame>Baseline and Visit 8 (Weeks 11-12)</time_frame>
    <description>Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on participant binge diary.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a 4-Week Cessation From Binge Eating</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>4-week cessation from binge eating is defined as no binge eating episodes for 28 consecutive days prior to the last study visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Body Weight at Week 12</measure>
    <time_frame>Baseline and Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks</measure>
    <time_frame>Baseline and Week 12/Early termination (ET)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks</measure>
    <time_frame>Baseline and Week 12/ET</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks</measure>
    <time_frame>Baseline and Week 12/ET</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Binge Eating Response</measure>
    <time_frame>Week 12/ET</time_frame>
    <description>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 = &lt;50% reduction during the time since the previous visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 (Weeks 11-12)</measure>
    <time_frame>Baseline and Visit 8 (Weeks 11-12)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Eating Inventory Scores at Week 12</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Binge Eating Scale (BES) Score at Week 12</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Week 12</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>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 &quot;1&quot; (almost never) to &quot;5&quot; (almost always). Summary scores were calculated and converted to t-score. A decrease from baseline in FrSBe total score represents improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Columbia-Suicide Severity Rating Scale (C-SSRS)</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amphetamine Cessation Symptom Assessment (ACSA) Total Score</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">383</enrollment>
  <condition>Binge Eating Disorder</condition>
  <arm_group>
    <arm_group_label>SPD489 (Lisdexamfetamine dimesylate)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SPD489 (Lisdexamfetamine dimesylate)</intervention_name>
    <description>50 or 70 mg administered orally, once-daily for up to 12 weeks</description>
    <arm_group_label>SPD489 (Lisdexamfetamine dimesylate)</arm_group_label>
    <other_name>Vyvanse, Venvanse, LDX</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered once-daily, orally, for up to 12 weeks</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria -&#xD;
&#xD;
          1. Subject is between 18-55 years of age.&#xD;
&#xD;
          2. Subject meets the following DSM-IV-TR criteria for a diagnosis of BED:&#xD;
&#xD;
             Recurrent episodes of binge eating. An episode of binge eating is characterized by&#xD;
             both of the following: eating, in a discrete period of time (eg, within a 2-hour&#xD;
             period) an amount of food that is definitely larger than most people would eat in a&#xD;
             similar period of time under similar conditions, and a sense of lack of control over&#xD;
             the eating (eg, a feeling that one cannot stop eating or control what or how much one&#xD;
             is eating).&#xD;
&#xD;
             The binge eating episodes are associated with at least 3 of the following: eating much&#xD;
             more rapidly than normal; eating until uncomfortably full; eating large amounts of&#xD;
             food when not feeling physically hungry; eating alone because of being embarrassed by&#xD;
             how much one is eating; feeling disgusted with oneself, depressed, or feeling very&#xD;
             guilty after overeating.&#xD;
&#xD;
             Marked distress regarding binge eating. The binge eating occurs, on average, at least&#xD;
             2 days a week for 6 months. The episodes of binge eating do not occur exclusively&#xD;
             during the course of bulimia nervosa or anorexia nervosa.&#xD;
&#xD;
          3. Subject's BED is of at least moderate severity with subjects reporting at least 3&#xD;
             binge eating days per week for the 14 days prior to the Baseline Visit (Visit 0) as&#xD;
             documented in the subject's binge diary. A binge day is a day during which at least 1&#xD;
             binge eating episode occurs.&#xD;
&#xD;
          4. Female subjects must have a negative serum B HCG pregnancy test and a negative urine&#xD;
             pregnancy test.&#xD;
&#xD;
        Exclusion Criteria-&#xD;
&#xD;
          1. Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa.&#xD;
&#xD;
          2. Subject is receiving psychotherapy (eg, supportive psychotherapy, cognitive behavior&#xD;
             therapy, interpersonal therapy) or weight loss support (eg, Weight Watchers) for BED&#xD;
             within 3 months.&#xD;
&#xD;
          3. Subject has used psychostimulants to facilitate fasting or dieting as a part of their&#xD;
             BED within 6 months.&#xD;
&#xD;
          4. Subject has a lifetime history of psychosis, mania, hypomania, dementia, or ADHD.&#xD;
&#xD;
          5. Subject is considered a suicide risk in the opinion of the investigator, has&#xD;
             previously made a suicide attempt, or is currently demonstrating active suicidal&#xD;
             ideation. Subjects with intermittent passive suicidal ideation are not necessarily&#xD;
             excluded based on the assessment of the investigator.&#xD;
&#xD;
          6. Subject has known history of symptomatic cardiovascular disease, advanced&#xD;
             arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm&#xD;
             abnormalities, coronary artery disease, or other serious cardiac problems.&#xD;
&#xD;
          7. Subject has recently initiated treatment with a lipid-lowering medication (within the&#xD;
             past 3 months).&#xD;
&#xD;
          8. Subject has a history of moderate or severe hypertension.&#xD;
&#xD;
          9. Subject is female and pregnant or nursing.&#xD;
&#xD;
         10. Subjects who have had bariatric surgery, lap bands, duodenal stents, or other&#xD;
             procedures for weight loss.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Birmingham Research Group</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Study Centers, LLC</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trimed Clinical Trials</name>
      <address>
        <city>Corona</city>
        <state>California</state>
        <zip>92880</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacology Research Institute</name>
      <address>
        <city>Encino</city>
        <state>California</state>
        <zip>91316</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacology Research Institute</name>
      <address>
        <city>Los Alamitos</city>
        <state>California</state>
        <zip>90720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Research Partners, LLC</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94812</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Research Across America</name>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92705</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Western Affiliated Research Institute, Inc.</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80209</zip>
        <country>United States</country>
      </address>
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  <location>
    <facility>
      <name>Gulfcoast Clinical Research</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33912</zip>
        <country>United States</country>
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      <name>Clinical Neuroscience Solutions, Inc.</name>
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        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
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      <name>Fidelity Clinical Research, Inc.</name>
      <address>
        <city>Lauderhill</city>
        <state>Florida</state>
        <zip>33319</zip>
        <country>United States</country>
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      <name>Compass Research LLC</name>
      <address>
        <city>Leesburg</city>
        <state>Florida</state>
        <zip>34748</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Scientific Clinical Research Inc.</name>
      <address>
        <city>North Miami</city>
        <state>Florida</state>
        <zip>33161</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Uptown Research Institute</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60640</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Alexian Brothers Behavioral Health Hospital</name>
      <address>
        <city>Hoffman Estates</city>
        <state>Illinois</state>
        <zip>60169</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>AMR Baber Research, Inc.</name>
      <address>
        <city>Naperville</city>
        <state>Illinois</state>
        <zip>60563</zip>
        <country>United States</country>
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  <location>
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      <name>Goldpoint Clinical Research, LLC</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46260</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Cypress Medical Research Center, LLC</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67226</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>McLean Hospital</name>
      <address>
        <city>Belmont</city>
        <state>Massachusetts</state>
        <zip>02478</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>St. Charles Psychiatric Associates/Midwest Research Group</name>
      <address>
        <city>Saint Charles</city>
        <state>Missouri</state>
        <zip>63304</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Center for Psychiatry and Behavioral Medicine, Inc.</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
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    <facility>
      <name>Pacific Research for Research and Evaluation</name>
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        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87102</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Wake Research Associates, LLC</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
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    </facility>
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  <location>
    <facility>
      <name>Community Research</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45227</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Midwest Clinical Research Center, LLC</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45417</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>North Star Medical Research</name>
      <address>
        <city>Middleburg Heights</city>
        <state>Ohio</state>
        <zip>44130</zip>
        <country>United States</country>
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    </facility>
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  <location>
    <facility>
      <name>IPS Research Company</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Center for Clinical Investigations, Inc.</name>
      <address>
        <city>Salem</city>
        <state>Oregon</state>
        <zip>97301</zip>
        <country>United States</country>
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    </facility>
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  <location>
    <facility>
      <name>The Clinical Trials Center, LLC</name>
      <address>
        <city>Jenkintown</city>
        <state>Pennsylvania</state>
        <zip>19046</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Suburban Research Associates</name>
      <address>
        <city>Media</city>
        <state>Pennsylvania</state>
        <zip>19063</zip>
        <country>United States</country>
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    </facility>
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  <location>
    <facility>
      <name>Clinical Trials Research Services, LLC</name>
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        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15206</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Radiant Research, Inc.</name>
      <address>
        <city>Anderson</city>
        <state>South Carolina</state>
        <zip>29621</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Coastal Carolina Research Center</name>
      <address>
        <city>Mount Pleasant</city>
        <state>South Carolina</state>
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        <country>United States</country>
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  <location>
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      <name>Clinical Neuroscience Solutions, Inc.</name>
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        <city>Memphis</city>
        <state>Tennessee</state>
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        <country>United States</country>
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  <location>
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      <name>Future Search Trials</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Futuresearch Trials of Dallas, L.P.</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grayline Clinical Drug Trials</name>
      <address>
        <city>Wichita Falls</city>
        <state>Texas</state>
        <zip>76309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research, Inc.</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neuropsychiatric Associates, LLC</name>
      <address>
        <city>Woodstock</city>
        <state>Vermont</state>
        <zip>05091</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charlottesville Medical Research Center, LLC</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance Research Group</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Clinical Research Center</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dean Foundation for Health, Research and Educations, Inc.</name>
      <address>
        <city>Middleton</city>
        <state>Wisconsin</state>
        <zip>53562</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ernovis GmbH</name>
      <address>
        <city>Berlin</city>
        <zip>10629</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinische Forschung Dresden GmbH</name>
      <address>
        <city>Dresden</city>
        <zip>01069</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Studienzentrum Nordwest, Gemeinschaftspraxis</name>
      <address>
        <city>Westerstede</city>
        <zip>26655</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Infanta Leonor</name>
      <address>
        <city>Madrid</city>
        <zip>28031</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lakarmottagning Ekdahl &amp; Kronberg</name>
      <address>
        <city>Malmo</city>
        <zip>22152</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sophiahemmet</name>
      <address>
        <city>Stockholm</city>
        <zip>11486</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stockholm Center for Eating Disorders</name>
      <address>
        <city>Stockholm</city>
        <zip>11850</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>McElroy SL, Hudson J, Ferreira-Cornwell MC, Radewonuk J, Whitaker T, Gasior M. Lisdexamfetamine Dimesylate for Adults with Moderate to Severe Binge Eating Disorder: Results of Two Pivotal Phase 3 Randomized Controlled Trials. Neuropsychopharmacology. 2016 Apr;41(5):1251-60. doi: 10.1038/npp.2015.275. Epub 2015 Sep 9.</citation>
    <PMID>26346638</PMID>
  </results_reference>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <results_first_submitted>March 18, 2014</results_first_submitted>
  <results_first_submitted_qc>July 17, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 21, 2014</results_first_posted>
  <last_update_submitted>May 16, 2021</last_update_submitted>
  <last_update_submitted_qc>May 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bulimia</mesh_term>
    <mesh_term>Feeding and Eating Disorders</mesh_term>
    <mesh_term>Binge-Eating Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lisdexamfetamine Dimesylate</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited between 12-Nov-2012 and 19-June-2013 and locations included medical clinics &amp; research centers.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>PLACEBO</title>
          <description>Placebo matching SPD489 capsule administered orally, once-daily, for up to 12 weeks.</description>
        </group>
        <group group_id="P2">
          <title>SPD489</title>
          <description>SPD489 capsule 30 (titration purpose only), 50 or 70 milligram (mg) administered orally, once-daily for up to 12 weeks once the optimal dose is reached.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="191"/>
                <participants group_id="P2" count="192"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="187"/>
                <participants group_id="P2" count="192"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="157"/>
                <participants group_id="P2" count="158"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="34"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Analysis Set was used for Baseline Measures. The Safety Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had at least 1 post-baseline safety assessment completed. Four participants did not receive investigational product, therefore n=379.</population>
      <group_list>
        <group group_id="B1">
          <title>PLACEBO</title>
          <description>Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.</description>
        </group>
        <group group_id="B2">
          <title>SPD489</title>
          <description>SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="187"/>
            <count group_id="B2" value="192"/>
            <count group_id="B3" value="379"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37.6" spread="10.21"/>
                    <measurement group_id="B2" value="38.5" spread="10.4"/>
                    <measurement group_id="B3" value="38.1" spread="10.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt;40 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="102"/>
                    <measurement group_id="B2" value="98"/>
                    <measurement group_id="B3" value="200"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=40 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                    <measurement group_id="B2" value="94"/>
                    <measurement group_id="B3" value="179"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="163"/>
                    <measurement group_id="B2" value="165"/>
                    <measurement group_id="B3" value="328"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>GERMANY</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SPAIN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SWEDEN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>UNITED STATES</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="165"/>
                    <measurement group_id="B2" value="173"/>
                    <measurement group_id="B3" value="338"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in the Number of Binge Days Per Week at Visit 8 (Weeks 11-12)</title>
        <description>Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on participant binge diary.</description>
        <time_frame>Baseline and Visit 8 (Weeks 11-12)</time_frame>
        <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Number of Binge Days Per Week at Visit 8 (Weeks 11-12)</title>
          <description>Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on participant binge diary.</description>
          <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).</population>
          <units>Binge days per week</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="184"/>
                <count group_id="O2" value="190"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.51" spread="0.125"/>
                    <measurement group_id="O2" value="-3.87" spread="0.124"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Repeated Measures Analysis</method>
            <param_type>Least squares mean difference</param_type>
            <param_value>-1.35</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.70</ci_lower_limit>
            <ci_upper_limit>-1.01</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores</title>
        <description>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.</description>
        <time_frame>Up to 12 weeks</time_frame>
        <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores</title>
          <description>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.</description>
          <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="184"/>
                <count group_id="O2" value="190"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.3" lower_limit="40.1" upper_limit="54.5"/>
                    <measurement group_id="O2" value="82.1" lower_limit="76.7" upper_limit="87.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a 4-Week Cessation From Binge Eating</title>
        <description>4-week cessation from binge eating is defined as no binge eating episodes for 28 consecutive days prior to the last study visit.</description>
        <time_frame>Up to 12 weeks</time_frame>
        <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a 4-Week Cessation From Binge Eating</title>
          <description>4-week cessation from binge eating is defined as no binge eating episodes for 28 consecutive days prior to the last study visit.</description>
          <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="184"/>
                <count group_id="O2" value="190"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.1" lower_limit="9.1" upper_limit="19.2"/>
                    <measurement group_id="O2" value="40.0" lower_limit="33.0" upper_limit="47.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Body Weight at Week 12</title>
        <time_frame>Baseline and Week 12</time_frame>
        <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Body Weight at Week 12</title>
          <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="184"/>
                <count group_id="O2" value="190"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" spread="0.295"/>
                    <measurement group_id="O2" value="-6.25" spread="0.292"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Repeated Measures Analysis</method>
            <param_type>Least squares mean difference</param_type>
            <param_value>-6.35</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.17</ci_lower_limit>
            <ci_upper_limit>-5.54</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12</title>
        <description>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.</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12</title>
          <description>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.</description>
          <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="183"/>
                <count group_id="O2" value="188"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.28" spread="0.550"/>
                    <measurement group_id="O2" value="-15.68" spread="0.546"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Repeated Measures Analysis</method>
            <param_type>Least squares mean difference</param_type>
            <param_value>-7.40</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.93</ci_lower_limit>
            <ci_upper_limit>-5.88</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks</title>
        <time_frame>Baseline and Week 12/Early termination (ET)</time_frame>
        <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks</title>
          <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.</population>
          <units>millimole per liter (mmol/L)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="183"/>
                <count group_id="O2" value="190"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.122" spread="0.0405"/>
                    <measurement group_id="O2" value="-0.077" spread="0.0393"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least squares mean difference</param_type>
            <param_value>-0.199</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.310</ci_lower_limit>
            <ci_upper_limit>-0.088</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks</title>
        <time_frame>Baseline and Week 12/ET</time_frame>
        <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks</title>
          <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.</population>
          <units>mmol/L</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="183"/>
                <count group_id="O2" value="190"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.094" spread="0.0435"/>
                    <measurement group_id="O2" value="-0.305" spread="0.0422"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Least squares mean difference</param_type>
            <param_value>-0.211</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.330</ci_lower_limit>
            <ci_upper_limit>-0.092</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks</title>
        <time_frame>Baseline and Week 12/ET</time_frame>
        <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks</title>
          <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.</population>
          <units>Percent hemoglobin</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="181"/>
                <count group_id="O2" value="189"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.016"/>
                    <measurement group_id="O2" value="-0.02" spread="0.015"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.308</p_value>
            <method>ANCOVA</method>
            <param_type>Least squares mean difference</param_type>
            <param_value>-0.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.07</ci_lower_limit>
            <ci_upper_limit>0.02</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Binge Eating Response</title>
        <description>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 = &lt;50% reduction during the time since the previous visit.</description>
        <time_frame>Week 12/ET</time_frame>
        <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.</description>
          </group>
        </group_list>
        <measure>
          <title>Binge Eating Response</title>
          <description>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 = &lt;50% reduction during the time since the previous visit.</description>
          <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="184"/>
                <count group_id="O2" value="187"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1-week cessation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.6"/>
                    <measurement group_id="O2" value="47.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Marked Reduction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.2"/>
                    <measurement group_id="O2" value="31.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate Reduction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.9"/>
                    <measurement group_id="O2" value="11.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Negative to Minimal Reduction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.2"/>
                    <measurement group_id="O2" value="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Multiplicity is not adjusted for this secondary efficacy endpoint in this study.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 (Weeks 11-12)</title>
        <time_frame>Baseline and Visit 8 (Weeks 11-12)</time_frame>
        <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 (Weeks 11-12)</title>
          <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).</population>
          <units>Binge episodes per week</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="184"/>
                <count group_id="O2" value="190"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.49" spread="0.170"/>
                    <measurement group_id="O2" value="-5.27" spread="0.168"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Multiplicity is not adjusted for this secondary efficacy endpoint in this study.</p_value_desc>
            <method>Mixed Models Repeated Measures Analysis</method>
            <param_type>Least squares mean difference</param_type>
            <param_value>-1.77</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.24</ci_lower_limit>
            <ci_upper_limit>-1.30</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Eating Inventory Scores at Week 12</title>
        <description>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.</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Eating Inventory Scores at Week 12</title>
          <description>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.</description>
          <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="184"/>
                <count group_id="O2" value="188"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cognitive Restraint of Eating</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.63" spread="0.331"/>
                    <measurement group_id="O2" value="3.27" spread="0.329"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Disinhibition of Eating</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.12" spread="0.286"/>
                    <measurement group_id="O2" value="-6.31" spread="0.285"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Perceived Hunger</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.90" spread="0.286"/>
                    <measurement group_id="O2" value="-6.60" spread="0.285"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Cognitive Restraint of Eating</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Multiplicity is not adjusted for this secondary efficacy endpoint in this study.</p_value_desc>
            <method>Mixed Models Repeated Measures Analysis</method>
            <param_type>Least squares mean difference</param_type>
            <param_value>1.65</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.72</ci_lower_limit>
            <ci_upper_limit>2.57</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Disinhibition of Eating</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Multiplicity is not adjusted for this secondary efficacy endpoint in this study.</p_value_desc>
            <method>Mixed Models Repeated Measures Analysis</method>
            <param_type>Least squares mean difference</param_type>
            <param_value>-4.19</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.98</ci_lower_limit>
            <ci_upper_limit>-3.39</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Perceived Hunger</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Multiplicity is not adjusted for this secondary efficacy endpoint in this study.</p_value_desc>
            <method>Mixed Models Repeated Measures Analysis</method>
            <param_type>Least squares mean difference</param_type>
            <param_value>-4.70</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.49</ci_lower_limit>
            <ci_upper_limit>-3.91</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Binge Eating Scale (BES) Score at Week 12</title>
        <description>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.</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Binge Eating Scale (BES) Score at Week 12</title>
          <description>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.</description>
          <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="184"/>
                <count group_id="O2" value="189"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.55" spread="0.763"/>
                    <measurement group_id="O2" value="-18.87" spread="0.755"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Multiplicity is not adjusted for this secondary efficacy endpoint in this study.</p_value_desc>
            <method>Mixed Models Repeated Measures Analysis</method>
            <param_type>Least squares mean difference</param_type>
            <param_value>-10.32</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.43</ci_lower_limit>
            <ci_upper_limit>-8.21</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Week 12</title>
        <description>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 &quot;1&quot; (almost never) to &quot;5&quot; (almost always). Summary scores were calculated and converted to t-score. A decrease from baseline in FrSBe total score represents improvement.</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Week 12</title>
          <description>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 &quot;1&quot; (almost never) to &quot;5&quot; (almost always). Summary scores were calculated and converted to t-score. A decrease from baseline in FrSBe total score represents improvement.</description>
          <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.</population>
          <units>t-scores</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="182"/>
                <count group_id="O2" value="187"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.09" spread="0.592"/>
                    <measurement group_id="O2" value="-3.40" spread="0.572"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.706</p_value>
            <p_value_desc>Multiplicity is not adjusted for this secondary efficacy endpoint in this study.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Least squares mean difference</param_type>
            <param_value>-0.31</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.93</ci_lower_limit>
            <ci_upper_limit>1.31</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility</title>
        <description>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.</description>
        <time_frame>Up to 12 weeks</time_frame>
        <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.</description>
          </group>
        </group_list>
        <measure>
          <title>EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility</title>
          <description>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.</description>
          <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="178"/>
                <count group_id="O2" value="187"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No problems walking about</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.6"/>
                    <measurement group_id="O2" value="87.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slight problems walking about</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.0"/>
                    <measurement group_id="O2" value="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate problems walking about</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8"/>
                    <measurement group_id="O2" value="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe problems walking about</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unable to walk about</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care</title>
        <description>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.</description>
        <time_frame>Up to 12 weeks</time_frame>
        <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.</description>
          </group>
        </group_list>
        <measure>
          <title>EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care</title>
          <description>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.</description>
          <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="178"/>
                <count group_id="O2" value="187"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No problems washing or dressing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.3"/>
                    <measurement group_id="O2" value="95.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slight problems washing or dressing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7"/>
                    <measurement group_id="O2" value="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate problems washing or dressing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9"/>
                    <measurement group_id="O2" value="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe problems washing or dressing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unable to wash or dress</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities</title>
        <description>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.</description>
        <time_frame>Up to 12 weeks</time_frame>
        <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.</description>
          </group>
        </group_list>
        <measure>
          <title>EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities</title>
          <description>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.</description>
          <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="186"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No problems doing usual activities</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.0"/>
                    <measurement group_id="O2" value="87.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slight problems doing usual activities</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.7"/>
                    <measurement group_id="O2" value="9.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate problems doing usual activities</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2"/>
                    <measurement group_id="O2" value="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe problems doing usual activities</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unable to do usual activities</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort</title>
        <description>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.</description>
        <time_frame>Up to 12 weeks</time_frame>
        <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.</description>
          </group>
        </group_list>
        <measure>
          <title>EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort</title>
          <description>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.</description>
          <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="178"/>
                <count group_id="O2" value="187"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No pain or discomfort</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.6"/>
                    <measurement group_id="O2" value="71.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slight pain or discomfort</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.5"/>
                    <measurement group_id="O2" value="20.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate pain or discomfort</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.3"/>
                    <measurement group_id="O2" value="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe pain or discomfort</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6"/>
                    <measurement group_id="O2" value="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extreme pain or discomfort</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression</title>
        <description>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.</description>
        <time_frame>Up to 12 weeks</time_frame>
        <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.</description>
          </group>
        </group_list>
        <measure>
          <title>EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression</title>
          <description>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.</description>
          <population>The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="178"/>
                <count group_id="O2" value="187"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Not anxious or depressed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.2"/>
                    <measurement group_id="O2" value="72.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slightly anxious or depressed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.7"/>
                    <measurement group_id="O2" value="16.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderately anxious or depressed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.9"/>
                    <measurement group_id="O2" value="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severely anxious or depressed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2"/>
                    <measurement group_id="O2" value="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extremely anxious or depressed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Columbia-Suicide Severity Rating Scale (C-SSRS)</title>
        <description>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.</description>
        <time_frame>Up to 12 weeks</time_frame>
        <population>The Safety Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had at least 1 post-baseline safety assessment completed. Not all participants had data for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.</description>
          </group>
        </group_list>
        <measure>
          <title>Columbia-Suicide Severity Rating Scale (C-SSRS)</title>
          <description>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.</description>
          <population>The Safety Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had at least 1 post-baseline safety assessment completed. Not all participants had data for this outcome.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="187"/>
                <count group_id="O2" value="191"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Suicidal Ideation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Suicidal behavior</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Amphetamine Cessation Symptom Assessment (ACSA) Total Score</title>
        <description>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.</description>
        <time_frame>Up to 12 weeks</time_frame>
        <population>The Safety Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had at least 1 post-baseline safety assessment completed. Not all participants had data for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.</description>
          </group>
        </group_list>
        <measure>
          <title>Amphetamine Cessation Symptom Assessment (ACSA) Total Score</title>
          <description>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.</description>
          <population>The Safety Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had at least 1 post-baseline safety assessment completed. Not all participants had data for this outcome.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="138"/>
                <count group_id="O2" value="155"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.3" spread="7.74"/>
                    <measurement group_id="O2" value="5.7" spread="7.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose of study drug up to 3 days after the last dose at up to 12 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>PLACEBO</title>
          <description>Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.</description>
        </group>
        <group group_id="E2">
          <title>SPD489</title>
          <description>SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (15.1)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="187"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="192"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="192"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="192"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="192"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Conversion disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="192"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (15.1)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="67" subjects_at_risk="187"/>
                <counts group_id="E2" subjects_affected="125" subjects_at_risk="192"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="187"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="192"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="19" subjects_affected="16" subjects_at_risk="187"/>
                <counts group_id="E2" events="86" subjects_affected="76" subjects_at_risk="192"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="15" subjects_affected="14" subjects_at_risk="187"/>
                <counts group_id="E2" events="19" subjects_affected="16" subjects_at_risk="192"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="187"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="192"/>
              </event>
              <event>
                <sub_title>Feeling jittery</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="187"/>
                <counts group_id="E2" events="13" subjects_affected="11" subjects_at_risk="192"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="187"/>
                <counts group_id="E2" events="18" subjects_affected="16" subjects_at_risk="192"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="187"/>
                <counts group_id="E2" events="10" subjects_affected="8" subjects_at_risk="192"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Heart rate increased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="187"/>
                <counts group_id="E2" events="14" subjects_affected="14" subjects_at_risk="192"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="187"/>
                <counts group_id="E2" events="17" subjects_affected="17" subjects_at_risk="192"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="19" subjects_affected="17" subjects_at_risk="187"/>
                <counts group_id="E2" events="32" subjects_affected="26" subjects_at_risk="192"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="187"/>
                <counts group_id="E2" events="13" subjects_affected="13" subjects_at_risk="192"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="15" subjects_affected="14" subjects_at_risk="187"/>
                <counts group_id="E2" events="44" subjects_affected="34" subjects_at_risk="192"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="192"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>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.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Shire</organization>
      <phone>+1 866 842 5335</phone>
      <email>ClinicalTransparency@shire.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01718483
org study id: SPD489-343
secondary id: 2012-003309-91
nct id: NCT01718483
lead sponsor: 
has dmc: No
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
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)
description: Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on participant binge diary.
measure: Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
time frame: Up to 12 weeks
description: 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.
measure: Percentage of Participants With a 4-Week Cessation From Binge Eating
time frame: Up to 12 weeks
description: 4-week cessation from binge eating is defined as no binge eating episodes for 28 consecutive days prior to the last study visit.
measure: Percent Change From Baseline in Body Weight at Week 12
time frame: Baseline and Week 12
measure: Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12
time frame: Baseline and Week 12
description: 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.
measure: Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks
time frame: Baseline and Week 12/Early termination (ET)
measure: Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks
time frame: Baseline and Week 12/ET
measure: Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks
time frame: Baseline and Week 12/ET
measure: Binge Eating Response
time frame: Week 12/ET
description: 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.
measure: 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)
measure: Change From Baseline in Eating Inventory Scores at Week 12
time frame: Baseline and Week 12
description: 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.
measure: Change From Baseline in Binge Eating Scale (BES) Score at Week 12
time frame: Baseline and Week 12
description: 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.
measure: Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Week 12
time frame: Baseline and Week 12
description: 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.
measure: EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility
time frame: Up to 12 weeks
description: 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.
measure: EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care
time frame: Up to 12 weeks
description: 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.
measure: EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities
time frame: Up to 12 weeks
description: 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.
measure: EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort
time frame: Up to 12 weeks
description: 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.
measure: EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression
time frame: Up to 12 weeks
description: 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.
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
time frame: Up to 12 weeks
description: 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.
measure: Amphetamine Cessation Symptom Assessment (ACSA) Total Score
time frame: Up to 12 weeks
description: 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.
arm group label: SPD489 (Lisdexamfetamine dimesylate)
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: SPD489 (Lisdexamfetamine dimesylate)
description: 50 or 70 mg administered orally, once-daily for up to 12 weeks
arm group label: SPD489 (Lisdexamfetamine dimesylate)
other name: Vyvanse, Venvanse, LDX
intervention type: Drug
intervention name: Placebo
description: Administered once-daily, orally, for up to 12 weeks
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Study Director
role: Study Director
affiliation: Takeda
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country: Germany
country: Spain
country: Sweden
country: United States
citation: McElroy SL, Hudson J, Ferreira-Cornwell MC, Radewonuk J, Whitaker T, Gasior M. Lisdexamfetamine Dimesylate for Adults with Moderate to Severe Binge Eating Disorder: Results of Two Pivotal Phase 3 Randomized Controlled Trials. Neuropsychopharmacology. 2016 Apr;41(5):1251-60. doi: 10.1038/npp.2015.275. Epub 2015 Sep 9.
PMID: 26346638
responsible party type: Sponsor
mesh term: Bulimia
mesh term: Feeding and Eating Disorders
mesh term: Binge-Eating Disorder
mesh term: Lisdexamfetamine Dimesylate
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 