<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <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/NCT01718509</url>
  </required_header>
  <id_info>
    <org_study_id>SPD489-344</org_study_id>
    <secondary_id>2012-003310-14</secondary_id>
    <nct_id>NCT01718509</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 SPD489-344, Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-optimization Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder</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>
  <detailed_description>
    <textblock>
      Not Required&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 26, 2012</start_date>
  <completion_date type="Actual">September 20, 2013</completion_date>
  <primary_completion_date type="Actual">September 20, 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 Which Spans Weeks 11/12</measure>
    <time_frame>Baseline and Visit 8 Which Spans 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 subject binge diary.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent 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 (kg) 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 up to 12 weeks</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 up to 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks</measure>
    <time_frame>Baseline and up to 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Binge Eating Response</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>Response is based on the reduction in the number of binge eating episodes. Responses were categorized as follows: -1-week Cessation = 100% reduction in binge episodes during the preceding 7 days -Marked Reduction = 99% to 75% reduction during the time since the previous visit -Moderate Reduction = 74% to 50% reduction during the time since the previous visit -Negative to Minimal Reduction = &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 Which Spans Weeks 11/12</measure>
    <time_frame>Baseline and Visit 8 Which Spans 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>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 subject has greater control over eating behavior and 4 denoting that a subject had less control over eating behavior. A total score (sum of the 16 items) may range from 16-64. A lower score indicates greater control over eating behavior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Up to 12 Weeks</measure>
    <time_frame>Baseline and up to 12 weeks</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. Subjects 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.</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>
  </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>
  </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>
  </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>
  </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 occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Amphetamine Cessation Symptom Assessment (ACSA) Total Score From Baseline to Week 12.</measure>
    <time_frame>Baseline and Week 12</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. Calculated as Baseline (Day 0) - Week 12 ACSA scores.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">390</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;
        The subject cannot be enrolled in the study before all of the following inclusion criteria&#xD;
        (including test results) are met:&#xD;
&#xD;
          1. Subject is between 18-55 years of age.&#xD;
&#xD;
          2. Subject meets the following Diagnostic and Statistical Manual of Mental Disorders&#xD;
             Fourth Edition - Text Revision (DSM-IV-TR) criteria for a diagnosis of BED:&#xD;
&#xD;
          3. Subject has a BED diagnosis.&#xD;
&#xD;
          4. Subject's BED is of at least moderate severity with subjects reporting at least 3&#xD;
             binge eating days per week.&#xD;
&#xD;
          5. Female subjects must have a negative serum B-HCG pregnancy test and a negative urine&#xD;
             pregnancy test and agree to comply with any applicable contraceptive requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects are excluded from the study if any of the following exclusion criteria are met:&#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;
&#xD;
          3. Subject has used psychostimulants to facilitate fasting or dieting as a part of their&#xD;
             BED.&#xD;
&#xD;
          4. Subject has a lifetime history of psychosis, mania, hypomania, dementia, or ADHD.&#xD;
&#xD;
          5. Subject is considered a suicide risk, has previously made a suicide attempt, or is&#xD;
             currently demonstrating active suicidal ideation.&#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 a history of moderate or severe hypertension.&#xD;
&#xD;
          8. Subject is female and pregnant or nursing.&#xD;
&#xD;
          9. Subject has had bariatric surgery, lap bands, duodenal stents, or other procedures for&#xD;
             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>Radiant Research, Inc.</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern California Research, LLC</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90210</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Scripps Clinical Research Services</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Pharmacology Research Institute</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92660</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Excel Research, Inc.</name>
      <address>
        <city>Oceanside</city>
        <state>California</state>
        <zip>92056</zip>
        <country>United States</country>
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      <name>PCSD - Feighner Research</name>
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        <city>San Diego</city>
        <state>California</state>
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      <name>Radiant Research, Inc.</name>
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        <city>Denver</city>
        <state>Colorado</state>
        <zip>80239</zip>
        <country>United States</country>
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    <facility>
      <name>Florida Clinical Research Center, LLC</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34201</zip>
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      <name>Florida Clinical Research Center, LLC</name>
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        <state>Florida</state>
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  <location>
    <facility>
      <name>Radiant Research, Inc.</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Research Institute</name>
      <address>
        <city>Ogden</city>
        <state>Utah</state>
        <zip>84405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NeuroScience, Inc.</name>
      <address>
        <city>Herndon</city>
        <state>Virginia</state>
        <zip>20170</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Summit Research Network (Seattle), LLC</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinische Forschung Berlin-Mitte GmbH</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinische Forschung Berlin Buch GmbH</name>
      <address>
        <city>Berlin</city>
        <zip>13125</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinische Forschung Schwerin GmbH</name>
      <address>
        <city>Schwerin</city>
        <zip>19055</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</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>June 2021</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <results_first_submitted>July 17, 2014</results_first_submitted>
  <results_first_submitted_qc>August 4, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 21, 2014</results_first_posted>
  <last_update_submitted>June 24, 2021</last_update_submitted>
  <last_update_submitted_qc>June 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 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>
      <group_list>
        <group group_id="P1">
          <title>PLACEBO</title>
          <description>Administered once-daily, orally, for up to 12 weeks</description>
        </group>
        <group group_id="P2">
          <title>SPD489</title>
          <description>50 or 70 mg administered orally, once-daily for up to 12 weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="195"/>
                <participants group_id="P2" count="195"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="147"/>
                <participants group_id="P2" count="147"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
                <participants group_id="P2" count="48"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="13"/>
              </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="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="11"/>
              </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>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>The Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and had at least 1 post-baseline safety assessment. 11 subjects from Site 015, 12 subjects had not been treated, and 1 subject had been treated but did not have any safety follow-up assessments were excluded from the Safety Analysis Set.</population>
      <group_list>
        <group group_id="B1">
          <title>PLACEBO</title>
        </group>
        <group group_id="B2">
          <title>SPD489</title>
        </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="185"/>
            <count group_id="B2" value="181"/>
            <count group_id="B3" value="366"/>
          </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="38.7" spread="10.01"/>
                    <measurement group_id="B2" value="37.1" spread="10.00"/>
                    <measurement group_id="B3" value="37.9" spread="10.02"/>
                  </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="90"/>
                    <measurement group_id="B2" value="108"/>
                    <measurement group_id="B3" value="198"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;= 40 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="95"/>
                    <measurement group_id="B2" value="73"/>
                    <measurement group_id="B3" value="168"/>
                  </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="153"/>
                    <measurement group_id="B2" value="159"/>
                    <measurement group_id="B3" value="312"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="54"/>
                  </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="9"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>UNITED STATES</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="176"/>
                    <measurement group_id="B2" value="170"/>
                    <measurement group_id="B3" value="346"/>
                  </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 Which Spans 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 subject binge diary.</description>
        <time_frame>Baseline and Visit 8 Which Spans Weeks 11/12</time_frame>
        <population>The Full Analysis Set was defined as all randomized subjects who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (i.e., number of binge days per week calculated for at least 1 week).</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Administered once-daily, orally, for up to 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>50 or 70 mg administered orally, once-daily for up to 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Number of Binge Days Per Week at Visit 8 Which Spans 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 subject binge diary.</description>
          <population>The Full Analysis Set was defined as all randomized subjects who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (i.e., number of binge days per week calculated for at least 1 week).</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="176"/>
                <count group_id="O2" value="174"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.26" spread="0.137"/>
                    <measurement group_id="O2" value="-3.92" spread="0.135"/>
                  </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>-1.66</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.04</ci_lower_limit>
            <ci_upper_limit>-1.28</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores</title>
        <description>Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.</description>
        <time_frame>Up to 12 weeks</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Administered once-daily, orally, for up to 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>50 or 70 mg administered orally, once-daily for up to 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores</title>
          <description>Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.</description>
          <population>Full Analysis Set</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="176"/>
                <count group_id="O2" value="174"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.9" lower_limit="35.5" upper_limit="50.2"/>
                    <measurement group_id="O2" value="86.2" lower_limit="81.1" upper_limit="91.3"/>
                  </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 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>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Administered once-daily, orally, for up to 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>50 or 70 mg administered orally, once-daily for up to 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percent 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>Full Analysis Set</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="176"/>
                <count group_id="O2" value="174"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.1" lower_limit="8.1" upper_limit="18.0"/>
                    <measurement group_id="O2" value="36.2" lower_limit="29.1" upper_limit="43.3"/>
                  </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 (kg) at Week 12</title>
        <time_frame>Baseline and week 12</time_frame>
        <population>Full Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Administered once-daily, orally, for up to 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>50 or 70 mg administered orally, once-daily for up to 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Body Weight (kg) at Week 12</title>
          <population>Full Analysis Set.</population>
          <units>percentage 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="176"/>
                <count group_id="O2" value="174"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.15" spread="0.353"/>
                    <measurement group_id="O2" value="-5.57" spread="0.350"/>
                  </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>-5.41</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.39</ci_lower_limit>
            <ci_upper_limit>-4.44</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>Full Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Administered once-daily, orally, for up to 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>50 or 70 mg administered orally, once-daily for up to 12 weeks</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>Full Analysis Set.</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="176"/>
                <count group_id="O2" value="174"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.42" spread="0.571"/>
                    <measurement group_id="O2" value="-15.36" spread="0.563"/>
                  </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>-7.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.51</ci_lower_limit>
            <ci_upper_limit>-6.36</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 up to 12 weeks</time_frame>
        <population>Full Analysis Set. Not all subjects had data for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Administered once-daily, orally, for up to 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>50 or 70 mg administered orally, once-daily for up to 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks</title>
          <population>Full Analysis Set. Not all subjects 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="153"/>
                <count group_id="O2" value="156"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.062" spread="0.0453"/>
                    <measurement group_id="O2" value="-0.133" spread="0.0449"/>
                  </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>0.002</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.196</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.321</ci_lower_limit>
            <ci_upper_limit>-0.070</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 up to 12 weeks</time_frame>
        <population>Full Analysis Set. Not all subjects had data for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Administered once-daily, orally, for up to 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>50 or 70 mg administered orally, once-daily for up to 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks</title>
          <population>Full Analysis Set. Not all subjects 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="153"/>
                <count group_id="O2" value="156"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.126" spread="0.0460"/>
                    <measurement group_id="O2" value="-0.204" spread="0.0456"/>
                  </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>0.234</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-0.077</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.205</ci_lower_limit>
            <ci_upper_limit>0.050</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 up to 12 weeks</time_frame>
        <population>Full Analysis Set. Not all subjects had data for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Administered once-daily, orally, for up to 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>50 or 70 mg administered orally, once-daily for up to 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks</title>
          <population>Full Analysis Set. Not all subjects had data for this outcome.</population>
          <units>Percent</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="154"/>
                <count group_id="O2" value="156"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.017"/>
                    <measurement group_id="O2" value="0.01" spread="0.017"/>
                  </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>0.185</p_value>
            <method>ANCOVA</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>0.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.02</ci_lower_limit>
            <ci_upper_limit>0.08</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. 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>Up to 12 weeks</time_frame>
        <population>Full Analysis Set. Not all subjects had data for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Administered once-daily, orally, for up to 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>50 or 70 mg administered orally, once-daily for up to 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Binge Eating Response</title>
          <description>Response is based on the reduction in the number of binge eating episodes. Responses were categorized as follows: -1-week Cessation = 100% reduction in binge episodes during the preceding 7 days -Marked Reduction = 99% to 75% reduction during the time since the previous visit -Moderate Reduction = 74% to 50% reduction during the time since the previous visit -Negative to Minimal Reduction = &lt;50% reduction during the time since the previous visit</description>
          <population>Full Analysis Set. Not all subjects 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="142"/>
                <count group_id="O2" value="145"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1-week cessation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.9"/>
                    <measurement group_id="O2" value="55.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Marked reduction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.4"/>
                    <measurement group_id="O2" value="22.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate reduction</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>Negative to minimal reduction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.0"/>
                    <measurement group_id="O2" value="4.8"/>
                  </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 Which Spans Weeks 11/12</title>
        <time_frame>Baseline and Visit 8 Which Spans Weeks 11/12</time_frame>
        <population>Full Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Administered once-daily, orally, for up to 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>50 or 70 mg administered orally, once-daily for up to 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 Which Spans Weeks 11/12</title>
          <population>Full Analysis Set.</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="176"/>
                <count group_id="O2" value="174"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.31" spread="0.194"/>
                    <measurement group_id="O2" value="-5.54" spread="0.193"/>
                  </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>-2.23</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.77</ci_lower_limit>
            <ci_upper_limit>-1.69</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Eating Inventory Scores at Week 12</title>
        <description>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>Full Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Administered once-daily, orally, for up to 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>50 or 70 mg administered orally, once-daily for up to 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Eating Inventory Scores at Week 12</title>
          <description>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>Full Analysis Set.</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="176"/>
                <count group_id="O2" value="174"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cognitive Restraint of Eating</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.44" spread="0.352"/>
                    <measurement group_id="O2" value="3.71" spread="0.347"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Disinhibition of Eating</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.01" spread="0.305"/>
                    <measurement group_id="O2" value="-5.61" spread="0.300"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Perceived Hunger</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.93" spread="0.318"/>
                    <measurement group_id="O2" value="-6.14" spread="0.313"/>
                  </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>0.011</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>1.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.29</ci_lower_limit>
            <ci_upper_limit>2.24</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>-3.60</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.44</ci_lower_limit>
            <ci_upper_limit>-2.76</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>-4.21</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.09</ci_lower_limit>
            <ci_upper_limit>-3.33</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 subject has greater control over eating behavior and 4 denoting that a subject had less control over eating behavior. A total score (sum of the 16 items) may range from 16-64. A lower score indicates greater control over eating behavior.</description>
        <time_frame>Baseline and week 12</time_frame>
        <population>Full Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Administered once-daily, orally, for up to 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>50 or 70 mg administered orally, once-daily for up to 12 weeks</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 subject has greater control over eating behavior and 4 denoting that a subject had less control over eating behavior. A total score (sum of the 16 items) may range from 16-64. A lower score indicates greater control over eating behavior.</description>
          <population>Full Analysis Set.</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="176"/>
                <count group_id="O2" value="174"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.24" spread="0.781"/>
                    <measurement group_id="O2" value="-17.52" spread="0.771"/>
                  </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>-9.28</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.44</ci_lower_limit>
            <ci_upper_limit>-7.12</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Up to 12 Weeks</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. Subjects 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 up to 12 weeks</time_frame>
        <population>Full Analysis Set. Not all subjects had data for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Administered once-daily, orally, for up to 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>50 or 70 mg administered orally, once-daily for up to 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Up to 12 Weeks</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. Subjects 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>Full Analysis Set. Not all subjects 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="153"/>
                <count group_id="O2" value="158"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.09" spread="0.655"/>
                    <measurement group_id="O2" value="-4.05" spread="0.644"/>
                  </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>0.298</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>-0.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.77</ci_lower_limit>
            <ci_upper_limit>0.85</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.</description>
        <time_frame>Up to 12 weeks</time_frame>
        <population>Full Analysis Set. Not all subjects had data for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Administered once-daily, orally, for up to 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>50 or 70 mg administered orally, once-daily for up to 12 weeks</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.</description>
          <population>Full Analysis Set. Not all subjects 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="168"/>
                <count group_id="O2" value="169"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No problems in walking about</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.9"/>
                    <measurement group_id="O2" value="91.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slight problems in walking about</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.9"/>
                    <measurement group_id="O2" value="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate problems walking about</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0"/>
                    <measurement group_id="O2" value="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe problems walking about</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2"/>
                    <measurement group_id="O2" value="0.6"/>
                  </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>
        <time_frame>Up to 12 weeks</time_frame>
        <population>Full Analysis Set. Not all subjects had data for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Administered once-daily, orally, for up to 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>50 or 70 mg administered orally, once-daily for up to 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care</title>
          <population>Full Analysis Set. Not all subjects 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="168"/>
                <count group_id="O2" value="169"/>
              </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="97.0"/>
                    <measurement group_id="O2" value="97.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slight problems washing or dressing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4"/>
                    <measurement group_id="O2" value="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate problems washing or dressing</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>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>
        <time_frame>Up to 12 weeks</time_frame>
        <population>Full Analysis Set. Not all subjects had data for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Administered once-daily, orally, for up to 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>50 or 70 mg administered orally, once-daily for up to 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities</title>
          <population>Full Analysis Set. Not all subjects 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="168"/>
                <count group_id="O2" value="169"/>
              </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="82.1"/>
                    <measurement group_id="O2" value="89.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slight problems dosin usual activities</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.3"/>
                    <measurement group_id="O2" value="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate problems doing usual activities</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0"/>
                    <measurement group_id="O2" value="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe problems doing usual activities</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6"/>
                    <measurement group_id="O2" value="0.6"/>
                  </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>
        <time_frame>Up to 12 weeks</time_frame>
        <population>Full Analysis Set. Not all subjects had data for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Administered once-daily, orally, for up to 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>50 or 70 mg administered orally, once-daily for up to 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort</title>
          <population>Full Analysis Set. Not all subjects 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="168"/>
                <count group_id="O2" value="169"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No pain or discomfort</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.6"/>
                    <measurement group_id="O2" value="76.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slight pain or discomfort</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.5"/>
                    <measurement group_id="O2" value="20.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate pain or discomfort</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0"/>
                    <measurement group_id="O2" value="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe pain or discomfort</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0"/>
                    <measurement group_id="O2" value="0"/>
                  </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="0.6"/>
                  </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>
        <time_frame>Up to 12 weeks</time_frame>
        <population>Full Analysis Set. Not all subjects had data for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Administered once-daily, orally, for up to 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>50 or 70 mg administered orally, once-daily for up to 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression</title>
          <population>Full Analysis Set. Not all subjects 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="168"/>
                <count group_id="O2" value="169"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Not anxious or depressed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.6"/>
                    <measurement group_id="O2" value="76.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slightly anxious or depressed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.2"/>
                    <measurement group_id="O2" value="20.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderately anxious or depressed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8"/>
                    <measurement group_id="O2" value="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severely anxious or depressed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extremely anxious or depressed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2"/>
                    <measurement group_id="O2" value="0.6"/>
                  </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 occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.</description>
        <time_frame>Up to 12 weeks</time_frame>
        <population>For this Outcome Measure the Safety Analysis Set is defined as all randomized subjects who took at least 1 dose of investigational product and who had at least 1 post-baseline safety assessment completed, and responded to the relevant questions for the C-SSRS. All subjects from Site 015 were excluded from the Safety Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Administered once-daily, orally, for up to 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>50 or 70 mg administered orally, once-daily for up to 12 weeks</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 occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.</description>
          <population>For this Outcome Measure the Safety Analysis Set is defined as all randomized subjects who took at least 1 dose of investigational product and who had at least 1 post-baseline safety assessment completed, and responded to the relevant questions for the C-SSRS. All subjects from Site 015 were excluded from the Safety Analysis Set.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="183"/>
                <count group_id="O2" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Suicidal ideation</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>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>Change in Amphetamine Cessation Symptom Assessment (ACSA) Total Score From Baseline to Week 12.</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. Calculated as Baseline (Day 0) - Week 12 ACSA scores.</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>Safety Analysis Set who completed ACSC at Baseline &amp; Week 12 Visits.</population>
        <group_list>
          <group group_id="O1">
            <title>PLACEBO</title>
            <description>Administered once-daily, orally, for up to 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>SPD489</title>
            <description>50 or 70 mg administered orally, once-daily for up to 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Amphetamine Cessation Symptom Assessment (ACSA) Total Score From Baseline to Week 12.</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. Calculated as Baseline (Day 0) - Week 12 ACSA scores.</description>
          <population>Safety Analysis Set who completed ACSC at Baseline &amp; Week 12 Visits.</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="142"/>
                <count group_id="O2" value="135"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0" spread="7.69"/>
                    <measurement group_id="O2" value="4.6" spread="5.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>The Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and had at least 1 follow-up safety assessment.</desc>
      <group_list>
        <group group_id="E1">
          <title>PLACEBO</title>
          <description>Administered once-daily, orally, for up to 12 weeks</description>
        </group>
        <group group_id="E2">
          <title>SPD489</title>
          <description>50 or 70 mg administered orally, once-daily for up to 12 weeks</description>
        </group>
      </group_list>
      <serious_events>
        <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="185"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fibula fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="185"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>Lumbar vertebral fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="185"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="185"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="185"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="185"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="43" subjects_at_risk="185"/>
                <counts group_id="E2" subjects_affected="100" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="185"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="185"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="185"/>
                <counts group_id="E2" events="60" subjects_affected="60" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="185"/>
                <counts group_id="E2" events="17" subjects_affected="16" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="12" subjects_affected="9" subjects_at_risk="185"/>
                <counts group_id="E2" events="21" subjects_affected="17" subjects_at_risk="181"/>
              </event>
              <event>
                <sub_title>Feeling jittery</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="185"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="181"/>
              </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="3" subjects_affected="3" subjects_at_risk="185"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="181"/>
              </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="16" subjects_at_risk="185"/>
                <counts group_id="E2" events="37" subjects_affected="32" subjects_at_risk="181"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="185"/>
                <counts group_id="E2" events="19" subjects_affected="19" subjects_at_risk="181"/>
              </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/NCT01718509
org study id: SPD489-344
secondary id: 2012-003310-14
nct id: NCT01718509
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
Not Required
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 Which Spans Weeks 11/12
time frame: Baseline and Visit 8 Which Spans Weeks 11/12
description: Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on subject binge diary.
measure: Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
time frame: Up to 12 weeks
description: Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
measure: Percent 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 (kg) 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 up to 12 weeks
measure: Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks
time frame: Baseline and up to 12 weeks
measure: Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks
time frame: Baseline and up to 12 weeks
measure: Binge Eating Response
time frame: Up to 12 weeks
description: Response is based on the reduction in the number of binge eating episodes. Responses were categorized as follows: -1-week Cessation = 100% reduction in binge episodes during the preceding 7 days -Marked Reduction = 99% to 75% reduction during the time since the previous visit -Moderate Reduction = 74% to 50% reduction during the time since the previous visit -Negative to Minimal Reduction = <50% reduction during the time since the previous visit
measure: Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 Which Spans Weeks 11/12
time frame: Baseline and Visit 8 Which Spans Weeks 11/12
measure: Change From Baseline in Eating Inventory Scores at Week 12
time frame: Baseline and week 12
description: 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 subject has greater control over eating behavior and 4 denoting that a subject had less control over eating behavior. A total score (sum of the 16 items) may range from 16-64. A lower score indicates greater control over eating behavior.
measure: Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Up to 12 Weeks
time frame: Baseline and up to 12 weeks
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. Subjects were asked to indicate the frequency with which they have engaged in certain behaviors using a rating scale from "1" (almost never) to "5" (almost always). Summary scores were calculated and converted to t-score. A decrease from baseline in FrSBe total score represents improvement.
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.
measure: EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care
time frame: Up to 12 weeks
measure: EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities
time frame: Up to 12 weeks
measure: EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort
time frame: Up to 12 weeks
measure: EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression
time frame: Up to 12 weeks
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 occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.
measure: Change in Amphetamine Cessation Symptom Assessment (ACSA) Total Score From Baseline to Week 12.
time frame: Baseline and Week 12
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. Calculated as Baseline (Day 0) - Week 12 ACSA scores.
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: 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: 