<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02202551</url>
  </required_header>
  <id_info>
    <org_study_id>ADS-AMT-PD302</org_study_id>
    <nct_id>NCT02202551</nct_id>
  </id_info>
  <brief_title>Open-Label Safety Study of ADS-5102 in PD Patients With LID</brief_title>
  <official_title>Open-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia (LID)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Adamas Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Adamas Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a 105-week open-label study to evaluate the safety and tolerability of ADS-5102 oral&#xD;
      capsules, an extended release formulation of amantadine, in Parkinson's Disease (PD) patients&#xD;
      with Levodopa Induced Dyskinesia (LID).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participation in this study was offered to subjects who were described by one of the&#xD;
      following 3 groups:&#xD;
&#xD;
        -  Group 1: Subjects who completed an Adamas efficacy study evaluating ADS-5102 in LID and&#xD;
           chose to immediately transition into the current study without a time gap; this group&#xD;
           was subdivided into Group 1A, consisting of subjects who received ADS-5102 in the&#xD;
           previous Adamas efficacy study, and Group 1P, consisting of subjects who received&#xD;
           placebo in the previous Adamas efficacy study&#xD;
&#xD;
        -  Group 2: Subjects who completed a previous Adamas efficacy study evaluating ADS-5102 in&#xD;
           LID and entered the current study with a time gap&#xD;
&#xD;
        -  Group 3: Subjects who would have been deemed ineligible for participation in a previous&#xD;
           Adamas efficacy study due to having undergone DBS&#xD;
&#xD;
      Consented subjects who completed Screening (Visit 1) and met study eligibility criteria were&#xD;
      to have a Baseline Visit and receive study drug. During Week 1, subjects took 170 mg of&#xD;
      ADS-5102 (1 capsule) daily at bedtime. For Week 2, the dose was increased to 340 mg (2&#xD;
      capsules) daily at bedtime; this dose was to continue through Week 100. During the final week&#xD;
      (Week 101) of the study, the ADS-5102 dose was reduced to 170 mg (1 capsule) daily at&#xD;
      bedtime. Subjects were enrolled into the study at Visit 2 (Baseline/Week 0) and were to&#xD;
      return to the clinic after 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 weeks of study drug&#xD;
      dosing. Subjects were to receive a telephone reminder at the end of Week 1 to increase their&#xD;
      dose during Week 2. At the Week 100 Visit, subjects were instructed to reduce their dose to 1&#xD;
      capsule daily at bedtime for 1 week. The amount of available, unused drug was assessed during&#xD;
      the Week 100 Visit; subjects were given an additional bottle of study drug, if needed, to&#xD;
      complete the 1 week of reduced dosing.&#xD;
&#xD;
      Efficacy, as measured with the MDS-UPDRS, was to be evaluated at all study visits, beginning&#xD;
      with the Screening Visit, and excluding the Baseline and Week 4 Visits. A Safety Follow-up&#xD;
      Visit was to occur approximately 2 weeks following the completion of treatment. AEs were&#xD;
      recorded beginning with the first dose of study drug and continued through the Safety&#xD;
      Follow-up Visit. Concomitant medications were recorded throughout the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">February 2018</completion_date>
  <primary_completion_date type="Actual">February 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations</measure>
    <time_frame>Up to 101 weeks</time_frame>
    <description>The primary objective of the study was to evaluate the safety and tolerability of ADS-5102 oral capsules, an extended release (ER) formulation of amantadine, administered at a dose of 340 mg once daily at bedtime for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores)</measure>
    <time_frame>Up to 101 weeks. MDS-UPDRS was performed at the following visits: Screening, Week 8, Week 16, Week 28, Week 40, Week 52, Week 64, Week 76, Week 88, Week 100 (or ET).</time_frame>
    <description>To evaluate clinical progression of PD as assessed by the MDS-UPDRS, combined score, Parts I, II, and III.&#xD;
Part I - non-motor experiences of daily living; Part II - motor experiences of daily living; Part III - motor examination. Parts I and II each contain 13 questions measured on a 5-point scale (0-4). Part III contains 18 objective rater assessments of the motor signs of PD measured on a 5-point scale (0-4).&#xD;
Total range for combined score (Part I-III) is = 0-176. Generally for MDS-UPDRS scores and sub-scores, the lower the score, the better.&#xD;
Parts I, II, and III are summed to make the total score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications)</measure>
    <time_frame>100 Weeks. MDS-UPDRS was performed at the following visits: Screening, Week 8, Week 16, Week 28, Week 40, Week 52, Week 64, Week 76, Week 88, Week 100 (or ET).</time_frame>
    <description>This component (Questions 4.1 - 4.6) includes time spent with dyskinesia, functional impact of dyskinesia, time spent in OFF state, functional impact of fluctuations, complexity of motor fluctuations, painful OFF-state dystonia. Questions 4.1-4.6 are summed to make the Part IV score.&#xD;
Generally for MDS-UPDRS scores and sub-scores, the lower the score, the better. Total range for Part IV is = 0-24</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">223</enrollment>
  <condition>Dyskinesia</condition>
  <condition>Levodopa Induced Dyskinesia (LID)</condition>
  <condition>Parkinson's Disease (PD)</condition>
  <arm_group>
    <arm_group_label>ADS-5102</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>amantadine HCl extended release</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ADS-5102</intervention_name>
    <arm_group_label>ADS-5102</arm_group_label>
    <other_name>amantadine HCl extended release</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed a current IRB/REB/IEC-approved informed consent form&#xD;
&#xD;
          -  Completed all study visits in previous Adamas efficacy study or were ineligible for&#xD;
             participation in previous Adamas studies due to having undergone prior deep brain&#xD;
             stimulation.&#xD;
&#xD;
          -  Parkinson's disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical&#xD;
             Diagnostic Criteria&#xD;
&#xD;
          -  On a stable regimen of antiparkinson's medications at least 30 days prior to&#xD;
             screening, including a levodopa preparation administered not less than three times&#xD;
             daily.&#xD;
&#xD;
          -  History of peak dose dyskinesia that might benefit from specific dyskinesia treatment&#xD;
             in the judgment of the subject and clinical investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Discontinued ADS-5102 in previous Adamas efficacy study due to intolerable or&#xD;
             unacceptable AEs considered to be related to ADS-5102&#xD;
&#xD;
          -  History of neurosurgical intervention related to Parkinson's disease, with the&#xD;
             exception of deep brain stimulation&#xD;
&#xD;
          -  History of seizures since completion of participation in previous Adamas studies or&#xD;
             within 2 years&#xD;
&#xD;
          -  History of stroke or TIA since completion of participation in previous Adamas studies&#xD;
             or within 2 years&#xD;
&#xD;
          -  History of cancer since completion of participation in previous Adamas studies or&#xD;
             within 2 years, with the following exceptions: adequately treated non-melanomatous&#xD;
             skin cancers, localized bladder cancer, non-metastatic prostate cancer or in situ&#xD;
             cervical cancer&#xD;
&#xD;
          -  Presence of cognitive impairment, as evidenced by a Mini-Mental Status Examination&#xD;
             (MMSE) score of less than 24 during screening&#xD;
&#xD;
          -  If female is pregnant or lactating&#xD;
&#xD;
          -  If a sexually active female, is not surgically sterile or at least 2 years&#xD;
             post-menopausal, or does not agree to utilize an effective method of contraception&#xD;
             from screening through at least 4 weeks after the completion of study treatment.&#xD;
&#xD;
          -  Treatment with an investigational drug (other than ADS-5102) or device within 30 days&#xD;
             prior to screening&#xD;
&#xD;
          -  Treatment with an investigational biologic within 6 months prior to screening&#xD;
&#xD;
          -  Current or planned participation in another interventional clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials Director</last_name>
    <role>Study Director</role>
    <affiliation>Adamas Pharmaceuticals, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sun City</city>
        <state>Arizona</state>
        <zip>85351</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fountain Valley</city>
        <state>California</state>
        <zip>92708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Reseda</city>
        <state>California</state>
        <zip>91335</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sunnyvale</city>
        <state>California</state>
        <zip>94085</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ventura</city>
        <state>California</state>
        <zip>93003</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <address>
        <city>Manchester</city>
        <state>Connecticut</state>
        <zip>06040</zip>
        <country>United States</country>
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  </location>
  <location>
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      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
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  <location>
    <facility>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32607</zip>
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      <address>
        <city>Jacksonville</city>
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        <zip>32209</zip>
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  <location>
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      <address>
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  <location>
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  <location>
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      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
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        <city>West Bloomfield</city>
        <state>Michigan</state>
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  <location>
    <facility>
      <address>
        <city>Golden Valley</city>
        <state>Minnesota</state>
        <zip>55427</zip>
        <country>United States</country>
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        <state>Missouri</state>
        <zip>63110</zip>
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    <facility>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
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    </facility>
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  <location>
    <facility>
      <address>
        <city>Commack</city>
        <state>New York</state>
        <zip>11725</zip>
        <country>United States</country>
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  <location>
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      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
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        <state>New York</state>
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        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
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        <state>Pennsylvania</state>
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        <state>Texas</state>
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  <location>
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        <state>Texas</state>
        <zip>77030-1</zip>
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        <state>Texas</state>
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      <address>
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        <state>Virginia</state>
        <zip>24018</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Kirkland</city>
        <state>Washington</state>
        <zip>98034</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53233</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
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  <location>
    <facility>
      <address>
        <city>Vienna</city>
        <zip>1080</zip>
        <country>Austria</country>
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  <location>
    <facility>
      <address>
        <city>Vienna</city>
        <zip>1220</zip>
        <country>Austria</country>
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    <facility>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2B7</zip>
        <country>Canada</country>
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  <location>
    <facility>
      <address>
        <city>Toronto</city>
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        <zip>M5T 2S8</zip>
        <country>Canada</country>
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    <facility>
      <address>
        <city>Regina</city>
        <state>Saskatchewan</state>
        <zip>S4T 1A5</zip>
        <country>Canada</country>
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  <location>
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      <address>
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      <address>
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      <address>
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  <location>
    <facility>
      <address>
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        <zip>81675</zip>
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        <city>Marburg</city>
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    </facility>
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  <location>
    <facility>
      <address>
        <city>Barcelona</city>
        <zip>08028</zip>
        <country>Spain</country>
      </address>
    </facility>
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  <location>
    <facility>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
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  <location>
    <facility>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
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  <location>
    <facility>
      <address>
        <city>Barcelona</city>
        <zip>08041</zip>
        <country>Spain</country>
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    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <reference>
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    <citation>Schwab RS, Poskanzer DC, England AC Jr, Young RR. Amantadine in Parkinson's disease. Review of more than two years' experience. JAMA. 1972 Nov 13;222(7):792-5. doi: 10.1001/jama.222.7.792. No abstract available.</citation>
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    <PMID>20198649</PMID>
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    <citation>Wright Willis A, Evanoff BA, Lian M, Criswell SR, Racette BA. Geographic and ethnic variation in Parkinson disease: a population-based study of US Medicare beneficiaries. Neuroepidemiology. 2010;34(3):143-51. doi: 10.1159/000275491. Epub 2010 Jan 15.</citation>
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  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <results_first_submitted>July 8, 2020</results_first_submitted>
  <results_first_submitted_qc>August 26, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 16, 2020</results_first_posted>
  <last_update_submitted>September 15, 2020</last_update_submitted>
  <last_update_submitted_qc>September 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Levodopa Induced Dyskinesia</keyword>
  <keyword>LID</keyword>
  <keyword>Parkinsonism</keyword>
  <keyword>Parkinson's Disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Dyskinesias</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amantadine</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 16, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/51/NCT02202551/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 13, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/51/NCT02202551/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Group 1a</title>
          <description>Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1A received ADS-5102 in the prior study.</description>
        </group>
        <group group_id="P2">
          <title>Group 1P</title>
          <description>Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1P received placebo in the prior study</description>
        </group>
        <group group_id="P3">
          <title>Group 2</title>
          <description>Subjects in Group 2 completed previous LID study, enrolled ADS-AMT-PD302 after a time gap.</description>
        </group>
        <group group_id="P4">
          <title>Group 3</title>
          <description>Subjects were not in a previous Adamas LID study and had prior DBS (deep brain stimulation)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
                <participants group_id="P2" count="78"/>
                <participants group_id="P3" count="24"/>
                <participants group_id="P4" count="61"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="41"/>
                <participants group_id="P3" count="14"/>
                <participants group_id="P4" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="37"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="22"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="19"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Needed to take excluded medication</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject moved away</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>DBS surgery</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Dyskinesia upon taper</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Site closure</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unable to complete visits per protocol</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Worsening Dyskinesia</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor's decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject unwilling to proceed</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject consent withdrawn</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>eGFR&lt;50mL/min/m2</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Group 1a</title>
          <description>Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1A received ADS-5102 in the prior study.</description>
        </group>
        <group group_id="B2">
          <title>Group 1P</title>
          <description>Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1P received placebo in the prior study</description>
        </group>
        <group group_id="B3">
          <title>Group 2</title>
          <description>Subjects in Group 2 completed previous LID study, enrolled ADS-AMT-PD302 after a time gap.</description>
        </group>
        <group group_id="B4">
          <title>Group 3</title>
          <description>Subjects were not in a previous Adamas LID study and had prior DBS (deep brain stimulation)</description>
        </group>
        <group group_id="B5">
          <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="60"/>
            <count group_id="B2" value="78"/>
            <count group_id="B3" value="24"/>
            <count group_id="B4" value="61"/>
            <count group_id="B5" value="223"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="39"/>
                    <measurement group_id="B5" value="109"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="22"/>
                    <measurement group_id="B5" value="114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="64.0" spread="9.81"/>
                    <measurement group_id="B2" value="65.9" spread="8.80"/>
                    <measurement group_id="B3" value="64.4" spread="7.81"/>
                    <measurement group_id="B4" value="60.2" spread="9.20"/>
                    <measurement group_id="B5" value="63.7" spread="9.32"/>
                  </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="26"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="20"/>
                    <measurement group_id="B5" value="92"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="41"/>
                    <measurement group_id="B5" value="131"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="54"/>
                    <measurement group_id="B5" value="208"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.86" spread="25.42"/>
                    <measurement group_id="B2" value="25.72" spread="24.63"/>
                    <measurement group_id="B3" value="25.26" spread="23.24"/>
                    <measurement group_id="B4" value="27.29" spread="4.891"/>
                    <measurement group_id="B5" value="26.14" spread="5.220"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>eGFR</title>
          <units>mL/min/1.73 m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="88.7" spread="24.31"/>
                    <measurement group_id="B2" value="92.2" spread="19.64"/>
                    <measurement group_id="B3" value="96.3" spread="20.54"/>
                    <measurement group_id="B4" value="92.1" spread="19.95"/>
                    <measurement group_id="B5" value="91.6" spread="21.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations</title>
        <description>The primary objective of the study was to evaluate the safety and tolerability of ADS-5102 oral capsules, an extended release (ER) formulation of amantadine, administered at a dose of 340 mg once daily at bedtime for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD).</description>
        <time_frame>Up to 101 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group 1a</title>
            <description>Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1A received ADS-5102 in the prior study.</description>
          </group>
          <group group_id="O2">
            <title>Group 1P</title>
            <description>Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1P received placebo in the prior study</description>
          </group>
          <group group_id="O3">
            <title>Group 2</title>
            <description>Subjects in Group 2 completed previous LID study, enrolled ADS-AMT-PD302 after a time gap.</description>
          </group>
          <group group_id="O4">
            <title>Group 3</title>
            <description>Subjects were not in a previous Adamas LID study and had prior DBS (deep brain stimulation)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations</title>
          <description>The primary objective of the study was to evaluate the safety and tolerability of ADS-5102 oral capsules, an extended release (ER) formulation of amantadine, administered at a dose of 340 mg once daily at bedtime for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                    <measurement group_id="O2" value="70"/>
                    <measurement group_id="O3" value="23"/>
                    <measurement group_id="O4" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Study drug-related AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="45"/>
                    <measurement group_id="O3" value="16"/>
                    <measurement group_id="O4" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Permanent discontinuation due to AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Permanent discontinuation due to drug-related AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="36"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild drug-related AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate drug-related AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="23"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe drug-related AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores)</title>
        <description>To evaluate clinical progression of PD as assessed by the MDS-UPDRS, combined score, Parts I, II, and III.&#xD;
Part I - non-motor experiences of daily living; Part II - motor experiences of daily living; Part III - motor examination. Parts I and II each contain 13 questions measured on a 5-point scale (0-4). Part III contains 18 objective rater assessments of the motor signs of PD measured on a 5-point scale (0-4).&#xD;
Total range for combined score (Part I-III) is = 0-176. Generally for MDS-UPDRS scores and sub-scores, the lower the score, the better.&#xD;
Parts I, II, and III are summed to make the total score.</description>
        <time_frame>Up to 101 weeks. MDS-UPDRS was performed at the following visits: Screening, Week 8, Week 16, Week 28, Week 40, Week 52, Week 64, Week 76, Week 88, Week 100 (or ET).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ADS-5102 1A</title>
            <description>Consisting of subjects who received ADS-5102 in the previous Adamas efficacy study</description>
          </group>
          <group group_id="O2">
            <title>ADS-5102 Group 1P</title>
            <description>Consisting of subjects who received placebo in the previous Adamas efficacy study</description>
          </group>
          <group group_id="O3">
            <title>ADS-5102 Group 2</title>
            <description>Subjects who completed a previous Adamas efficacy study evaluating ADS-5102 in LID and entered the current study with a time gap</description>
          </group>
          <group group_id="O4">
            <title>ADS-5102 Group 3</title>
            <description>Subjects who would have been deemed ineligible for participation in a previous Adamas efficacy study due to having undergone DBS</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores)</title>
          <description>To evaluate clinical progression of PD as assessed by the MDS-UPDRS, combined score, Parts I, II, and III.&#xD;
Part I - non-motor experiences of daily living; Part II - motor experiences of daily living; Part III - motor examination. Parts I and II each contain 13 questions measured on a 5-point scale (0-4). Part III contains 18 objective rater assessments of the motor signs of PD measured on a 5-point scale (0-4).&#xD;
Total range for combined score (Part I-III) is = 0-176. Generally for MDS-UPDRS scores and sub-scores, the lower the score, the better.&#xD;
Parts I, II, and III are summed to make the total score.</description>
          <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="60"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.8" spread="18.43"/>
                    <measurement group_id="O2" value="45.6" spread="19.24"/>
                    <measurement group_id="O3" value="52.8" spread="23.06"/>
                    <measurement group_id="O4" value="52.4" spread="16.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="10.03"/>
                    <measurement group_id="O2" value="-2.8" spread="14.11"/>
                    <measurement group_id="O3" value="0.8" spread="12.00"/>
                    <measurement group_id="O4" value="-5.3" spread="10.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" spread="13.41"/>
                    <measurement group_id="O2" value="-1.4" spread="16.22"/>
                    <measurement group_id="O3" value="5.7" spread="15.53"/>
                    <measurement group_id="O4" value="-5.2" spread="11.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" spread="10.04"/>
                    <measurement group_id="O2" value="1.5" spread="12.49"/>
                    <measurement group_id="O3" value="6.5" spread="14.18"/>
                    <measurement group_id="O4" value="-5.3" spread="12.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5" spread="15.43"/>
                    <measurement group_id="O2" value="-0.4" spread="15.20"/>
                    <measurement group_id="O3" value="1.6" spread="18.29"/>
                    <measurement group_id="O4" value="-4.8" spread="12.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.2" spread="16.78"/>
                    <measurement group_id="O2" value="2.6" spread="14.57"/>
                    <measurement group_id="O3" value="6.1" spread="18.34"/>
                    <measurement group_id="O4" value="-4.6" spread="15.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 64</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.8" spread="14.83"/>
                    <measurement group_id="O2" value="2.6" spread="14.57"/>
                    <measurement group_id="O3" value="6.1" spread="18.34"/>
                    <measurement group_id="O4" value="-4.6" spread="15.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 76</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.7" spread="19.58"/>
                    <measurement group_id="O2" value="7.3" spread="19.18"/>
                    <measurement group_id="O3" value="9.4" spread="19.10"/>
                    <measurement group_id="O4" value="-4.9" spread="13.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 88</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.3" spread="16.65"/>
                    <measurement group_id="O2" value="3.7" spread="13.80"/>
                    <measurement group_id="O3" value="6.4" spread="22.65"/>
                    <measurement group_id="O4" value="0.9" spread="16.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 100</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.4" spread="15.66"/>
                    <measurement group_id="O2" value="3.7" spread="15.29"/>
                    <measurement group_id="O3" value="6.5" spread="16.46"/>
                    <measurement group_id="O4" value="4.1" spread="17.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications)</title>
        <description>This component (Questions 4.1 - 4.6) includes time spent with dyskinesia, functional impact of dyskinesia, time spent in OFF state, functional impact of fluctuations, complexity of motor fluctuations, painful OFF-state dystonia. Questions 4.1-4.6 are summed to make the Part IV score.&#xD;
Generally for MDS-UPDRS scores and sub-scores, the lower the score, the better. Total range for Part IV is = 0-24</description>
        <time_frame>100 Weeks. MDS-UPDRS was performed at the following visits: Screening, Week 8, Week 16, Week 28, Week 40, Week 52, Week 64, Week 76, Week 88, Week 100 (or ET).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group 1a</title>
            <description>Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1A received ADS-5102 in the prior study.</description>
          </group>
          <group group_id="O2">
            <title>Group 1P</title>
            <description>Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1P received placebo in the prior study</description>
          </group>
          <group group_id="O3">
            <title>Group 2</title>
            <description>Subjects in Group 2 completed previous LID study, enrolled ADS-AMT-PD302 after a time gap.</description>
          </group>
          <group group_id="O4">
            <title>Group 3</title>
            <description>Subjects were not in a previous Adamas LID study and had prior DBS (deep brain stimulation)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications)</title>
          <description>This component (Questions 4.1 - 4.6) includes time spent with dyskinesia, functional impact of dyskinesia, time spent in OFF state, functional impact of fluctuations, complexity of motor fluctuations, painful OFF-state dystonia. Questions 4.1-4.6 are summed to make the Part IV score.&#xD;
Generally for MDS-UPDRS scores and sub-scores, the lower the score, the better. Total range for Part IV is = 0-24</description>
          <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="60"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5" spread="3.38"/>
                    <measurement group_id="O2" value="9.6" spread="3.07"/>
                    <measurement group_id="O3" value="9.8" spread="3.92"/>
                    <measurement group_id="O4" value="10.4" spread="2.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in Baseline from Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="3.21"/>
                    <measurement group_id="O2" value="-3.4" spread="3.27"/>
                    <measurement group_id="O3" value="-3.6" spread="4.16"/>
                    <measurement group_id="O4" value="-4.0" spread="4.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in Baseline from Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="3.61"/>
                    <measurement group_id="O2" value="-3.2" spread="3.61"/>
                    <measurement group_id="O3" value="-1.1" spread="5.03"/>
                    <measurement group_id="O4" value="-3.9" spread="3.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="3.61"/>
                    <measurement group_id="O2" value="-3.3" spread="3.12"/>
                    <measurement group_id="O3" value="-1.4" spread="3.84"/>
                    <measurement group_id="O4" value="-4.4" spread="3.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="3.95"/>
                    <measurement group_id="O2" value="-2.8" spread="3.39"/>
                    <measurement group_id="O3" value="-2.9" spread="4.81"/>
                    <measurement group_id="O4" value="-4.7" spread="4.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="3.64"/>
                    <measurement group_id="O2" value="-2.9" spread="3.56"/>
                    <measurement group_id="O3" value="-2.5" spread="4.40"/>
                    <measurement group_id="O4" value="-3.6" spread="3.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 64</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="3.82"/>
                    <measurement group_id="O2" value="-3.3" spread="3.42"/>
                    <measurement group_id="O3" value="-1.9" spread="4.32"/>
                    <measurement group_id="O4" value="-2.5" spread="4.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 76</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="4.20"/>
                    <measurement group_id="O2" value="-2.9" spread="3.67"/>
                    <measurement group_id="O3" value="-2.7" spread="3.90"/>
                    <measurement group_id="O4" value="-3.7" spread="3.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 88</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="3.77"/>
                    <measurement group_id="O2" value="-2.8" spread="3.60"/>
                    <measurement group_id="O3" value="-3.7" spread="4.69"/>
                    <measurement group_id="O4" value="-4.3" spread="3.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 100</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="3.28"/>
                    <measurement group_id="O2" value="-2.4" spread="4.19"/>
                    <measurement group_id="O3" value="-3.6" spread="3.66"/>
                    <measurement group_id="O4" value="-3.6" spread="3.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>100 weeks</time_frame>
      <desc>Safety was assessed through adverse events (AEs), physical examinations, vital signs, and laboratory parameters (hematology, serum chemistry, urinalysis, and pregnancy testing, if appropriate).</desc>
      <group_list>
        <group group_id="E1">
          <title>Group 1a</title>
          <description>Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1A received ADS-5102 in the prior study.</description>
        </group>
        <group group_id="E2">
          <title>Group 1P</title>
          <description>Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1P received placebo in the prior study</description>
        </group>
        <group group_id="E3">
          <title>Group 2</title>
          <description>Subjects in Group 2 completed previous LID study, enrolled ADS-AMT-PD302 after a time gap.</description>
        </group>
        <group group_id="E4">
          <title>Group 3</title>
          <description>Subjects were not in a previous Adamas LID study and had prior DBS (deep brain stimulation)</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (17.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="17" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <description>Non-St-Elevation mycardial infarction</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <description>Supraventricular tachycardia</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <description>Cardiac arrest</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <description>Cardiac chest pain (etiology unknown)</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <description>Heart attack</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <description>Cardiac arrhythmia</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <description>Angina pectoris due to coronary vascular disease</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <description>Semi-myocardial infarction</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Hypertensive cardiomyopathy</sub_title>
                <description>Hypertensive cardiomyopathy</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <description>Anterior myocardial infarction with acute pulmonary edema</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo positional</sub_title>
                <description>Benign paroxysmal positional vertigo</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis</sub_title>
                <description>Acute colitis</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Volvulus</sub_title>
                <description>Sigmoid, volvulus</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Colonic pseudo-obstruction</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <description>Oglive Syndrome</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <description>Slow transit constipation</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <description>Intestinal oclusion</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <description>Intestinal obstruction</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <description>Abdominal pain (obstipation)</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <description>Epigastralgia</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Adverse drug reaction</sub_title>
                <description>Adverse drug reaction to melatonin and stool softner</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <description>Death due to natural causes</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Abasia</sub_title>
                <description>Unable to walk</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <description>Tongue swelling due to allergic reaction</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Arthritis bacteria</sub_title>
                <description>Septic right knee requiring right total nee arthroplasty</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Clostridium difficile sepsis</sub_title>
                <description>C. diff sepsis</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <description>Septic shock</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Pseudomonal sepsis</sub_title>
                <description>Pseudomona aeruginosa sepsis</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <description>Persistent urinary tract infection</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <description>Pneumonia</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Staphylococcal sepsis</sub_title>
                <description>MRSA bacteremia, presumably due to infected hardware</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <description>Cellulitis - right leg</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <description>Sepsis</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Laceration</sub_title>
                <description>Left knee laceration</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <description>Right distal radius fracture</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <description>Ribs fracture</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <description>Shoulder luxation</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <description>Comminuted intertrichanteric right hip fracture</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <description>Fractured right ankle</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <description>Left hip fracture</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <description>Left intertrochanteric femur fracture</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Traumatic fracture</sub_title>
                <description>Traumatic serial rib fractures</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Acetabulum fracture</sub_title>
                <description>Acetabulum fracture right</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Pelvic fracture</sub_title>
                <description>Fractured pelvis</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Confusion postoperative</sub_title>
                <description>Confusion after hip prothesis surgery</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <description>Left wrist fracture</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Traumatic fracture</sub_title>
                <description>Right tibial fracture - motor vehicle accident</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <description>Broken ankle (left)</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <description>Dysfunction of deep brain stimulation device with increased disposition to fall</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <description>Craniocerebral injury</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Forearm fracture</sub_title>
                <description>Forearm fracture left</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Ostenecrosis</sub_title>
                <description>Avascular necrosis of the right patella</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <description>Worsening right knee degenerative disease</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <description>Rhabdomyolysis</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <description>Worsening of right knee pain</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Joint effusion</sub_title>
                <description>Left knee join effusion</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma of the colon</sub_title>
                <description>Adenocarcinoma of the ascending colon (right)</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <description>Encephalopathy</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Lymphoadenopathy</sub_title>
                <description>Lymphoadenopathy</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Neuroleptic malignant syndrome</sub_title>
                <description>Malignant neuroleptic syndrome</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Parkinson's disease</sub_title>
                <description>Worsening of Parkinson's disease</description>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <description>Paraesthesia</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>On and Off Phenomenon</sub_title>
                <description>Worsening motor fluctuations related to PD</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Restless leg syndrome</sub_title>
                <description>Worsening of restless leg syndrome</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Hypokinesia</sub_title>
                <description>Hypokinesis</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Intercostal neuralgia</sub_title>
                <description>Intercostal neuralgia</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Parkinson's disease</sub_title>
                <description>Parkinsonism aggravation</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Dyskinesia</sub_title>
                <description>Worsening of dyskinesia (reassessment about alternative therapeutic)</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychiatric disorder</sub_title>
                <description>Psychosis</description>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <description>Acute confusional syndrome</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <description>Attempted suicide</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <description>Altered mental status</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <description>Altered mental state, confusion (occurred 30 days after the last dose)</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <description>Worsening anxiety</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <description>Suicidal ideation with intent for self harm</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Mania</sub_title>
                <description>Acute psychiatric disorder (maniac manifestation)</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <description>Worsening benign prostatic hypertrophy</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory arrest</sub_title>
                <description>Respiratory arrest</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Haemothorax</sub_title>
                <description>Hemothorax</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <description>Respiratory distress secondary to pneumonia</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <description>Hypertensive crisis</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Venous thrombosis</sub_title>
                <description>Thrombosis of the vena saphena magna in the thigh and lower leg left side</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (17.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="47" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="61" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="21" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="45" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Edema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <description>Fall</description>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="23" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>On and off phenomenon</sub_title>
                <description>These events were worsening of disease over the duration of the study</description>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Parkinson's disease</sub_title>
                <description>Worsening of Parkinson's disease</description>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Hallucination (pooled)</sub_title>
                <description>Hallucination (Pooled = combines all Preferred terms that contain the term &quot;Hallucination.&quot;</description>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Hallucination, visual</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Abnormal dreams</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Livedo reticularis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="61"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Reed Johnson</name_or_title>
      <organization>Adamas Pharmaceuticals, Inc.</organization>
      <phone>510-450-3500</phone>
      <email>rjohnson@adamaspharma.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/NCT02202551
org study id: ADS-AMT-PD302
nct id: NCT02202551
lead sponsor: 
has dmc: No
This is a 105-week open-label study to evaluate the safety and tolerability of ADS-5102 oral
      capsules, an extended release formulation of amantadine, in Parkinson's Disease (PD) patients
      with Levodopa Induced Dyskinesia (LID).
Participation in this study was offered to subjects who were described by one of the
      following 3 groups:

        -  Group 1: Subjects who completed an Adamas efficacy study evaluating ADS-5102 in LID and
           chose to immediately transition into the current study without a time gap; this group
           was subdivided into Group 1A, consisting of subjects who received ADS-5102 in the
           previous Adamas efficacy study, and Group 1P, consisting of subjects who received
           placebo in the previous Adamas efficacy study

        -  Group 2: Subjects who completed a previous Adamas efficacy study evaluating ADS-5102 in
           LID and entered the current study with a time gap

        -  Group 3: Subjects who would have been deemed ineligible for participation in a previous
           Adamas efficacy study due to having undergone DBS

      Consented subjects who completed Screening (Visit 1) and met study eligibility criteria were
      to have a Baseline Visit and receive study drug. During Week 1, subjects took 170 mg of
      ADS-5102 (1 capsule) daily at bedtime. For Week 2, the dose was increased to 340 mg (2
      capsules) daily at bedtime; this dose was to continue through Week 100. During the final week
      (Week 101) of the study, the ADS-5102 dose was reduced to 170 mg (1 capsule) daily at
      bedtime. Subjects were enrolled into the study at Visit 2 (Baseline/Week 0) and were to
      return to the clinic after 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 weeks of study drug
      dosing. Subjects were to receive a telephone reminder at the end of Week 1 to increase their
      dose during Week 2. At the Week 100 Visit, subjects were instructed to reduce their dose to 1
      capsule daily at bedtime for 1 week. The amount of available, unused drug was assessed during
      the Week 100 Visit; subjects were given an additional bottle of study drug, if needed, to
      complete the 1 week of reduced dosing.

      Efficacy, as measured with the MDS-UPDRS, was to be evaluated at all study visits, beginning
      with the Screening Visit, and excluding the Baseline and Week 4 Visits. A Safety Follow-up
      Visit was to occur approximately 2 weeks following the completion of treatment. AEs were
      recorded beginning with the first dose of study drug and continued through the Safety
      Follow-up Visit. Concomitant medications were recorded throughout the study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations
time frame: Up to 101 weeks
description: The primary objective of the study was to evaluate the safety and tolerability of ADS-5102 oral capsules, an extended release (ER) formulation of amantadine, administered at a dose of 340 mg once daily at bedtime for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD).
measure: Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores)
time frame: Up to 101 weeks. MDS-UPDRS was performed at the following visits: Screening, Week 8, Week 16, Week 28, Week 40, Week 52, Week 64, Week 76, Week 88, Week 100 (or ET).
description: To evaluate clinical progression of PD as assessed by the MDS-UPDRS, combined score, Parts I, II, and III.
Part I - non-motor experiences of daily living; Part II - motor experiences of daily living; Part III - motor examination. Parts I and II each contain 13 questions measured on a 5-point scale (0-4). Part III contains 18 objective rater assessments of the motor signs of PD measured on a 5-point scale (0-4).
Total range for combined score (Part I-III) is = 0-176. Generally for MDS-UPDRS scores and sub-scores, the lower the score, the better.
Parts I, II, and III are summed to make the total score.
measure: Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications)
time frame: 100 Weeks. MDS-UPDRS was performed at the following visits: Screening, Week 8, Week 16, Week 28, Week 40, Week 52, Week 64, Week 76, Week 88, Week 100 (or ET).
description: This component (Questions 4.1 - 4.6) includes time spent with dyskinesia, functional impact of dyskinesia, time spent in OFF state, functional impact of fluctuations, complexity of motor fluctuations, painful OFF-state dystonia. Questions 4.1-4.6 are summed to make the Part IV score.
Generally for MDS-UPDRS scores and sub-scores, the lower the score, the better. Total range for Part IV is = 0-24
arm group label: ADS-5102
arm group type: Experimental
description: amantadine HCl extended release
intervention type: Drug
intervention name: ADS-5102
arm group label: ADS-5102
other name: amantadine HCl extended release
criteria: 
gender: All
minimum age: 30 Years
maximum age: 85 Years
healthy volunteers: No
last name: Clinical Trials Director
role: Study Director
affiliation: Adamas Pharmaceuticals, Inc.
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country: Austria
country: Canada
country: France
country: Germany
country: Spain
country: United States
citation: Aoki FY, Sitar DS. Clinical pharmacokinetics of amantadine hydrochloride. Clin Pharmacokinet. 1988 Jan;14(1):35-51. doi: 10.2165/00003088-198814010-00003.
PMID: 3280212
citation: Colosimo C, Martinez-Martin P, Fabbrini G, Hauser RA, Merello M, Miyasaki J, Poewe W, Sampaio C, Rascol O, Stebbins GT, Schrag A, Goetz CG. Task force report on scales to assess dyskinesia in Parkinson's disease: critique and recommendations. Mov Disord. 2010 Jul 15;25(9):1131-42. doi: 10.1002/mds.23072.
PMID: 20310033
citation: da Silva-Junior FP, Braga-Neto P, Sueli Monte F, de Bruin VM. Amantadine reduces the duration of levodopa-induced dyskinesia: a randomized, double-blind, placebo-controlled study. Parkinsonism Relat Disord. 2005 Nov;11(7):449-52. doi: 10.1016/j.parkreldis.2005.05.008. Epub 2005 Sep 9.
PMID: 16154788
citation: Dallos V, Heathfield K, Stone P, Allen FA. Use of amantadine in Parkinson's disease. Results of a double-blind trial. Br Med J. 1970 Oct 3;4(5726):24-6. doi: 10.1136/bmj.4.5726.24.
PMID: 4919119
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responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Dyskinesias
mesh term: Amantadine
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