<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/NCT01683838</url>
  </required_header>
  <id_info>
    <org_study_id>SCI-F302</org_study_id>
    <nct_id>NCT01683838</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Oral Fampridine-Sustained Release (SR) for the Treatment of Spasticity Resulting From Spinal Cord Injury</brief_title>
  <official_title>Double-Blind, Placebo-Controlled, 12-Week Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR in Subjects With Moderate to Severe Spasticity Resulting From Chronic, Incomplete Spinal Cord Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Acorda Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Acorda Therapeutics</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Normally, nerve fibers carry electrical impulses through the spinal cord, providing&#xD;
      communication between the brain and the arms and legs. In people with spinal cord injury,&#xD;
      some fibers may be destroyed at the site of injury, while others remain connected but do not&#xD;
      work correctly to carry electrical impulses. As a result, subjects with an incomplete spinal&#xD;
      cord injury may have spasticity which is muscle spasms or muscle stiffness that makes&#xD;
      movement difficult. Fampridine-SR is an experimental drug that increases the ability of the&#xD;
      nerve to conduct electrical impulses. This study will examine the effects of Fampridine-SR on&#xD;
      moderate to severe lower-limb spasticity, as well as the effects on bodily functions such as&#xD;
      bladder control, bowel function and sexual function. The study will also examine the possible&#xD;
      risks of taking Fampridine-SR.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2002</start_date>
  <completion_date type="Actual">February 2004</completion_date>
  <primary_completion_date type="Actual">November 2003</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity</measure>
    <time_frame>Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98</time_frame>
    <description>The Ashworth evaluates the functioning of two lower extremity muscle groups, the hamstring and quadriceps muscles, while in the supine position. The test measures extension of the right and left hamstring muscle and flexion of the right and left quadriceps muscle using the following 5-point grading scale:&#xD;
1=no increased tone; 2=slight increase in tone, giving a &quot;catch&quot; when the affected part is moved in flexion or extension; 3=more marked increase in tone, but affected part is easily flexed; 4=considerable increase in tone, passive movement is difficult; 5=affected part is rigid in flexion and extension.&#xD;
The Ashworth Score was determined by adding all individual scores for each muscle group and dividing by four. Higher Ashworth Scores indicated greater spasticity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Double-blind Change From Baseline in Mean Subject's Global Impression (SGI) Scores</measure>
    <time_frame>Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98</time_frame>
    <description>The SGI is a 7-unit ordinal scale used by the subject to evaluate the effects of study medication on his/her quality of life during the preceding week, with higher scores denoting greater satisfaction. A positive change score in SGI signifies improved outcome.&#xD;
The questionnaire consisted of one question (How do you feel about the effects of the investigational drug over the past 7 days?). The answer was based on a numerical rating scale where 1=terrible; 2=unhappy; 3=mostly dissatisfied; 4=neutral/mixed; 5=mostly satisfied; 6=pleased; 7=delighted.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Double-blind Change From Baseline in Mean Spasm Frequency/Severity Scores</measure>
    <time_frame>Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98</time_frame>
    <description>The Spasm Frequency score is the average rating by the clinician of the left and right arm(s) and leg(s), each evaluated on a 4-point scale (from 0=no spasms to 4=spontaneous spasms occurring more than ten times per hour), with higher scores denoting a greater degree of muscle spasms.&#xD;
The Spasm Severity score is the average rating of the left and right arm(s) and leg(s), each evaluated on a three-point scale (mild, moderate, or severe) as rated by the clinician on the basis of patient self-report.&#xD;
On both, a negative change in score signifies improvement in muscle spasms. The average Spasm Frequency/Spasm Severity Score was calculated as the average of the left and right non-missing scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Double-blind Change From Baseline in Mean Clinician's Global Impression (CGI) Scores</measure>
    <time_frame>Baseline (visits 2,3) average of days 7-14 and double-blind treatment period (visits 4-7) average of days 28-98)</time_frame>
    <description>The supervising clinician rated the patient's neurological condition following treatment as compared to the screening visit on a seven-point scale (from 1=very much improved to 7=very much worse). The assessment was based on the clinician's overall impression of the patient's neurological status (specifically bowel, bladder, and sexual function; spasticity; and other neurological functions) and general state of health related to his or her participation in the study. Negative change scores indicated a change for the better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stable-dose Change From Baseline in Mean American Spinal Injury Association(ASIA) Total Motor Score</measure>
    <time_frame>Baseline (visits 2,3) average score days 7,14 and stable-dose treatment period (visits 5-7) average score days 56-98</time_frame>
    <description>Ten key muscle groups for the right and left sides were rated on a 0 (absent) to 5 (normal) scale, with a possible total score of 100. Higher positive change scores indicate improved motor function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Mean International Index of Erectile Function (IIEF) Score</measure>
    <time_frame>Baseline (visit 1) average score obtained at day 1 and stable treatment period (visit 7) average score day 98</time_frame>
    <description>Male patients were asked to complete the IIEF questionnaire on sexual function. The IIEF is a brief, reliable, and valid self-administered questionnaire of 15 questions (items) that were categorized into five domains: Erectile Function (EF) scores: 0-6 Severe dysfunction, 7-12 Moderate dysfunction, 13-18 Mild to moderate dysfunction, 19-24 Mild dysfunction, 25-30 No dysfunction. Orgasmic Function (OF) score range: 0-2 Severe dysfunction to 9-10 No dysfunction, Sexual Desire (SD) score range: 0-2 Severe dysfunction to 9-10 No dysfunction, Intercourse Satisfaction (IS) score range: 0-3 Severe dysfunction to 13-15 No dysfunction, and Overall Satisfaction (OS) score range: 0-2 Severe dysfunction to 9-10 No dysfunction.&#xD;
Domain scores were derived by summing the individual items within a given domain. Final scale ranges from 0 (negative) to 5 (positive). A positive change in IIEF domain scores signifies improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Mean Female Sexual Function Index (FSFI) Scores</measure>
    <time_frame>Baseline (visit 1) average score obtained at day 1 and stable treatment period (visits 4-7) average score days 28-98</time_frame>
    <description>The FSFI is a brief, reliable, and valid self-administered questionnaire of 19 questions (items). It contains six domains: Desire (2 items score range: 1 Very low or none at all to 5 Very high), Arousal (4 items score range: 0 No sexual activity to 5 Almost always or always), Lubrication (4 items score range: 0 No sexual activity to 5 Almost always or always), Orgasm (3 items score range: 0 No sexual activity to 5 Almost always or always), Satisfaction (3 items score range: 0 No sexual activity to 5 Very satisfied) and Pain (3 items score range: 0 Did not attempt intercourse to 5 Almost never or never).&#xD;
A positive change signifies improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adjusted Mean Change in Subject Bladder/Bowel Function Diary Scores</measure>
    <time_frame>Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98</time_frame>
    <description>Bowel/bladder questions pertaining to the average number of times per day the patient experienced accidental urination/leakage and the average number of bowel movements per day were asked of all patients daily.&#xD;
A negative change in patient bladder/bowel function diary score signifies improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adjusted Mean Change in Subject Bowel Function Diary Scores</measure>
    <time_frame>Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98</time_frame>
    <description>Bowel questions pertaining to the average number of minutes per day spent on bowel routine were asked of all patients daily.&#xD;
A negative change in patient bowel function diary score signifies improvement.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">204</enrollment>
  <condition>Spinal Cord Injury</condition>
  <condition>Muscle Spasticity</condition>
  <arm_group>
    <arm_group_label>fampridine-SR 50mg/day</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fampridine-SR</intervention_name>
    <description>25mg bid (twice daily)</description>
    <arm_group_label>fampridine-SR 50mg/day</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Incomplete traumatic Spinal Cord Injury (at least 18 months prior and stable for 6&#xD;
             months)&#xD;
&#xD;
          -  Moderate to severe lower-limb spasticity&#xD;
&#xD;
          -  Able to give informed consent and willing to comply with protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  History of seizures&#xD;
&#xD;
          -  Existing or history of frequent Urinary Tract Infections&#xD;
&#xD;
          -  History of drug or alcohol abuse&#xD;
&#xD;
          -  Allergy to pyridine-containing substances&#xD;
&#xD;
          -  Received a botox injection 4 months prior to study&#xD;
&#xD;
          -  Received an investigational drug within 30 days&#xD;
&#xD;
          -  Previously treated with 4-aminopyridine (4-AP)&#xD;
&#xD;
          -  Not on stable medication dosing in 3 weeks prior to study&#xD;
&#xD;
          -  Abnormal ECG or laboratory value at screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Blight, MD</last_name>
    <role>Study Director</role>
    <affiliation>Acorda Therapeutics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UAB School of Medicine, 190 Spain Rehab Center</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Long Beach VA Medical Center</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, Davis</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Clara Valley Medical Center</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Craig Hospital</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital for Special Care</name>
      <address>
        <city>New Britain</city>
        <state>Connecticut</state>
        <zip>06503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hines VA Hospital</name>
      <address>
        <city>Hines</city>
        <state>Illinois</state>
        <zip>60141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston University Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rehabilitation Institute of Michigan</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minneapolis VA Hospital</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55417</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Missouri</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Louis University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester/Strong Memorial Hospital</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUNY Upstate Clinical Trials Office</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helen Hayes Hospital</name>
      <address>
        <city>West Haverstraw</city>
        <state>New York</state>
        <zip>13045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charlotte Institute of Rehabilitation</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal AHEC</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami Valley Hospital- Rehabilitation Institute of Medicine</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45409</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA North Texas Health Care System</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwestern Medical Center at Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>INOVA Institute of Research and Education</name>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <zip>22042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Virginia/VCU</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington Medical Center, Dept. of Rehabilitation</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wood VA Medical Center</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53295</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Sciences Centre</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3A 1M4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chedoke-McMaster Hospital</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N 3Z5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Mary's of the Lake Hospital</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L 5A2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.acorda.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>August 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <results_first_submitted>July 23, 2013</results_first_submitted>
  <results_first_submitted_qc>January 6, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 5, 2014</results_first_posted>
  <last_update_submitted>July 27, 2017</last_update_submitted>
  <last_update_submitted_qc>July 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>spinal cord injury</keyword>
  <keyword>muscle spasticity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Spasticity</mesh_term>
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>4-Aminopyridine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The randomization schedule was created prior to the start of the study, and was blocked and stratified by site and by concomitant anti-spasmodic medication status to ensure treatment balance between patients who were treated with anti-spasmodic medications upon entry into the study and those who were not.</recruitment_details>
      <pre_assignment_details>Investigational drug assignments were communicated through an Interactive Voice Response System (IVRS).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Fampridine-SR 50mg/Day</title>
          <description>Fampridine-SR : 25mg bid (twice daily)</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo : Placebo</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="104"/>
                <participants group_id="P2" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Intent to Treat (ITT) Population</title>
              <participants_list>
                <participants group_id="P1" count="103"/>
                <participants group_id="P2" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Population</title>
              <participants_list>
                <participants group_id="P1" count="103"/>
                <participants group_id="P2" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Efficacy Population</title>
              <participants_list>
                <participants group_id="P1" count="89"/>
                <participants group_id="P2" count="93"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="78"/>
                <participants group_id="P2" count="88"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>104 patients randomized to Fampridine-SR 50mg/day 100 patients randomized to Placebo. Total patients randomized = 204.&#xD;
Overall, 203 (99.5%) patients were included in the ITT population, 182 (89.2%) in the Efficacy population and 203 (99.5%) in the Safety population.</population>
      <group_list>
        <group group_id="B1">
          <title>Fampridine-SR 50mg/Day</title>
          <description>Fampridine-SR : 25mg bid (twice daily)</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo : Placebo</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="103"/>
            <count group_id="B2" value="100"/>
            <count group_id="B3" value="203"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.3" spread="11.79"/>
                    <measurement group_id="B2" value="40.5" spread="12.25"/>
                    <measurement group_id="B3" value="40.9" spread="12.00"/>
                  </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="17"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                    <measurement group_id="B2" value="86"/>
                    <measurement group_id="B3" value="172"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="92"/>
                    <measurement group_id="B2" value="87"/>
                    <measurement group_id="B3" value="179"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian/Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity</title>
        <description>The Ashworth evaluates the functioning of two lower extremity muscle groups, the hamstring and quadriceps muscles, while in the supine position. The test measures extension of the right and left hamstring muscle and flexion of the right and left quadriceps muscle using the following 5-point grading scale:&#xD;
1=no increased tone; 2=slight increase in tone, giving a &quot;catch&quot; when the affected part is moved in flexion or extension; 3=more marked increase in tone, but affected part is easily flexed; 4=considerable increase in tone, passive movement is difficult; 5=affected part is rigid in flexion and extension.&#xD;
The Ashworth Score was determined by adding all individual scores for each muscle group and dividing by four. Higher Ashworth Scores indicated greater spasticity.</description>
        <time_frame>Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98</time_frame>
        <population>Intent to Treat (ITT) Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Fampridine-SR 50mg/Day</title>
            <description>Fampridine-SR : 25mg bid (twice daily)</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo : Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity</title>
          <description>The Ashworth evaluates the functioning of two lower extremity muscle groups, the hamstring and quadriceps muscles, while in the supine position. The test measures extension of the right and left hamstring muscle and flexion of the right and left quadriceps muscle using the following 5-point grading scale:&#xD;
1=no increased tone; 2=slight increase in tone, giving a &quot;catch&quot; when the affected part is moved in flexion or extension; 3=more marked increase in tone, but affected part is easily flexed; 4=considerable increase in tone, passive movement is difficult; 5=affected part is rigid in flexion and extension.&#xD;
The Ashworth Score was determined by adding all individual scores for each muscle group and dividing by four. Higher Ashworth Scores indicated greater spasticity.</description>
          <population>Intent to Treat (ITT) Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.28" spread="0.046"/>
                    <measurement group_id="O2" value="-0.16" spread="0.047"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Double-blind Change From Baseline in Mean Subject's Global Impression (SGI) Scores</title>
        <description>The SGI is a 7-unit ordinal scale used by the subject to evaluate the effects of study medication on his/her quality of life during the preceding week, with higher scores denoting greater satisfaction. A positive change score in SGI signifies improved outcome.&#xD;
The questionnaire consisted of one question (How do you feel about the effects of the investigational drug over the past 7 days?). The answer was based on a numerical rating scale where 1=terrible; 2=unhappy; 3=mostly dissatisfied; 4=neutral/mixed; 5=mostly satisfied; 6=pleased; 7=delighted.</description>
        <time_frame>Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98</time_frame>
        <population>ITT population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Fampridine-SR 50mg/Day</title>
            <description>Fampridine-SR : 25mg bid (twice daily)</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo : Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Double-blind Change From Baseline in Mean Subject's Global Impression (SGI) Scores</title>
          <description>The SGI is a 7-unit ordinal scale used by the subject to evaluate the effects of study medication on his/her quality of life during the preceding week, with higher scores denoting greater satisfaction. A positive change score in SGI signifies improved outcome.&#xD;
The questionnaire consisted of one question (How do you feel about the effects of the investigational drug over the past 7 days?). The answer was based on a numerical rating scale where 1=terrible; 2=unhappy; 3=mostly dissatisfied; 4=neutral/mixed; 5=mostly satisfied; 6=pleased; 7=delighted.</description>
          <population>ITT population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0" spread="0.07"/>
                    <measurement group_id="O2" value="0.1" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Double-blind Change From Baseline in Mean Spasm Frequency/Severity Scores</title>
        <description>The Spasm Frequency score is the average rating by the clinician of the left and right arm(s) and leg(s), each evaluated on a 4-point scale (from 0=no spasms to 4=spontaneous spasms occurring more than ten times per hour), with higher scores denoting a greater degree of muscle spasms.&#xD;
The Spasm Severity score is the average rating of the left and right arm(s) and leg(s), each evaluated on a three-point scale (mild, moderate, or severe) as rated by the clinician on the basis of patient self-report.&#xD;
On both, a negative change in score signifies improvement in muscle spasms. The average Spasm Frequency/Spasm Severity Score was calculated as the average of the left and right non-missing scores.</description>
        <time_frame>Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98</time_frame>
        <population>ITT Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Fampridine-SR 50mg/Day</title>
            <description>Fampridine-SR : 25mg bid (twice daily)</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo : Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Double-blind Change From Baseline in Mean Spasm Frequency/Severity Scores</title>
          <description>The Spasm Frequency score is the average rating by the clinician of the left and right arm(s) and leg(s), each evaluated on a 4-point scale (from 0=no spasms to 4=spontaneous spasms occurring more than ten times per hour), with higher scores denoting a greater degree of muscle spasms.&#xD;
The Spasm Severity score is the average rating of the left and right arm(s) and leg(s), each evaluated on a three-point scale (mild, moderate, or severe) as rated by the clinician on the basis of patient self-report.&#xD;
On both, a negative change in score signifies improvement in muscle spasms. The average Spasm Frequency/Spasm Severity Score was calculated as the average of the left and right non-missing scores.</description>
          <population>ITT Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Arm Spasm Frequency</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.13" spread="0.051"/>
                    <measurement group_id="O2" value="0.02" spread="0.053"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leg Spasm Frequency</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.12" spread="0.051"/>
                    <measurement group_id="O2" value="-0.10" spread="0.052"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Arm Spasm Severity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.09" spread="0.034"/>
                    <measurement group_id="O2" value="-0.02" spread="0.035"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leg Spasm Severity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.14" spread="0.040"/>
                    <measurement group_id="O2" value="-0.07" spread="0.041"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Double-blind Change From Baseline in Mean Clinician's Global Impression (CGI) Scores</title>
        <description>The supervising clinician rated the patient's neurological condition following treatment as compared to the screening visit on a seven-point scale (from 1=very much improved to 7=very much worse). The assessment was based on the clinician's overall impression of the patient's neurological status (specifically bowel, bladder, and sexual function; spasticity; and other neurological functions) and general state of health related to his or her participation in the study. Negative change scores indicated a change for the better.</description>
        <time_frame>Baseline (visits 2,3) average of days 7-14 and double-blind treatment period (visits 4-7) average of days 28-98)</time_frame>
        <population>ITT Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Fampridine-SR 50mg/Day</title>
            <description>Fampridine-SR : 25mg bid (twice daily)</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo : Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Double-blind Change From Baseline in Mean Clinician's Global Impression (CGI) Scores</title>
          <description>The supervising clinician rated the patient's neurological condition following treatment as compared to the screening visit on a seven-point scale (from 1=very much improved to 7=very much worse). The assessment was based on the clinician's overall impression of the patient's neurological status (specifically bowel, bladder, and sexual function; spasticity; and other neurological functions) and general state of health related to his or her participation in the study. Negative change scores indicated a change for the better.</description>
          <population>ITT Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="0.06"/>
                    <measurement group_id="O2" value="-0.2" spread="0.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stable-dose Change From Baseline in Mean American Spinal Injury Association(ASIA) Total Motor Score</title>
        <description>Ten key muscle groups for the right and left sides were rated on a 0 (absent) to 5 (normal) scale, with a possible total score of 100. Higher positive change scores indicate improved motor function.</description>
        <time_frame>Baseline (visits 2,3) average score days 7,14 and stable-dose treatment period (visits 5-7) average score days 56-98</time_frame>
        <population>ITT Population. Number of participants analyzed is number of patients with available data at both baseline and stable-blind treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Fampridine-SR 50mg/Day</title>
            <description>Fampridine-SR : 25mg bid (twice daily)</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo : Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Stable-dose Change From Baseline in Mean American Spinal Injury Association(ASIA) Total Motor Score</title>
          <description>Ten key muscle groups for the right and left sides were rated on a 0 (absent) to 5 (normal) scale, with a possible total score of 100. Higher positive change scores indicate improved motor function.</description>
          <population>ITT Population. Number of participants analyzed is number of patients with available data at both baseline and stable-blind treatment period.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
                <count group_id="O2" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="0.51"/>
                    <measurement group_id="O2" value="0.7" spread="0.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Mean International Index of Erectile Function (IIEF) Score</title>
        <description>Male patients were asked to complete the IIEF questionnaire on sexual function. The IIEF is a brief, reliable, and valid self-administered questionnaire of 15 questions (items) that were categorized into five domains: Erectile Function (EF) scores: 0-6 Severe dysfunction, 7-12 Moderate dysfunction, 13-18 Mild to moderate dysfunction, 19-24 Mild dysfunction, 25-30 No dysfunction. Orgasmic Function (OF) score range: 0-2 Severe dysfunction to 9-10 No dysfunction, Sexual Desire (SD) score range: 0-2 Severe dysfunction to 9-10 No dysfunction, Intercourse Satisfaction (IS) score range: 0-3 Severe dysfunction to 13-15 No dysfunction, and Overall Satisfaction (OS) score range: 0-2 Severe dysfunction to 9-10 No dysfunction.&#xD;
Domain scores were derived by summing the individual items within a given domain. Final scale ranges from 0 (negative) to 5 (positive). A positive change in IIEF domain scores signifies improvement.</description>
        <time_frame>Baseline (visit 1) average score obtained at day 1 and stable treatment period (visit 7) average score day 98</time_frame>
        <population>ITT Population. N = number of participants analyzed with available data at both baseline and stable treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Fampridine-SR 50mg/Day</title>
            <description>Fampridine-SR : 25mg bid (twice daily)</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo : Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Mean International Index of Erectile Function (IIEF) Score</title>
          <description>Male patients were asked to complete the IIEF questionnaire on sexual function. The IIEF is a brief, reliable, and valid self-administered questionnaire of 15 questions (items) that were categorized into five domains: Erectile Function (EF) scores: 0-6 Severe dysfunction, 7-12 Moderate dysfunction, 13-18 Mild to moderate dysfunction, 19-24 Mild dysfunction, 25-30 No dysfunction. Orgasmic Function (OF) score range: 0-2 Severe dysfunction to 9-10 No dysfunction, Sexual Desire (SD) score range: 0-2 Severe dysfunction to 9-10 No dysfunction, Intercourse Satisfaction (IS) score range: 0-3 Severe dysfunction to 13-15 No dysfunction, and Overall Satisfaction (OS) score range: 0-2 Severe dysfunction to 9-10 No dysfunction.&#xD;
Domain scores were derived by summing the individual items within a given domain. Final scale ranges from 0 (negative) to 5 (positive). A positive change in IIEF domain scores signifies improvement.</description>
          <population>ITT Population. N = number of participants analyzed with available data at both baseline and stable treatment period.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>EF (Fampridine-SR Number (N) =65, Placebo N=77)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="1.09"/>
                    <measurement group_id="O2" value="1.6" spread="1.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>OF (Fampridine-SR N=64, Placebo N=76)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="0.36"/>
                    <measurement group_id="O2" value="0.0" spread="0.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SD (Fampridine-SR N=64, Placebo N=75)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0" spread="0.23"/>
                    <measurement group_id="O2" value="0.0" spread="0.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IS (Fampridine-SR N=64, N=76)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="0.55"/>
                    <measurement group_id="O2" value="0.4" spread="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>OS (Fampridine-SR N=51, Placebo N=66)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="0.27"/>
                    <measurement group_id="O2" value="0.3" spread="0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Mean Female Sexual Function Index (FSFI) Scores</title>
        <description>The FSFI is a brief, reliable, and valid self-administered questionnaire of 19 questions (items). It contains six domains: Desire (2 items score range: 1 Very low or none at all to 5 Very high), Arousal (4 items score range: 0 No sexual activity to 5 Almost always or always), Lubrication (4 items score range: 0 No sexual activity to 5 Almost always or always), Orgasm (3 items score range: 0 No sexual activity to 5 Almost always or always), Satisfaction (3 items score range: 0 No sexual activity to 5 Very satisfied) and Pain (3 items score range: 0 Did not attempt intercourse to 5 Almost never or never).&#xD;
A positive change signifies improvement.</description>
        <time_frame>Baseline (visit 1) average score obtained at day 1 and stable treatment period (visits 4-7) average score days 28-98</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fampridine-SR 50mg/Day</title>
            <description>Fampridine-SR : 25mg bid (twice daily)</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo : Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Mean Female Sexual Function Index (FSFI) Scores</title>
          <description>The FSFI is a brief, reliable, and valid self-administered questionnaire of 19 questions (items). It contains six domains: Desire (2 items score range: 1 Very low or none at all to 5 Very high), Arousal (4 items score range: 0 No sexual activity to 5 Almost always or always), Lubrication (4 items score range: 0 No sexual activity to 5 Almost always or always), Orgasm (3 items score range: 0 No sexual activity to 5 Almost always or always), Satisfaction (3 items score range: 0 No sexual activity to 5 Very satisfied) and Pain (3 items score range: 0 Did not attempt intercourse to 5 Almost never or never).&#xD;
A positive change signifies improvement.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Desire</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="0.26"/>
                    <measurement group_id="O2" value="0.2" spread="0.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Arousal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="0.37"/>
                    <measurement group_id="O2" value="0.2" spread="0.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lubrication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="0.45"/>
                    <measurement group_id="O2" value="-0.2" spread="0.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Orgasm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.18"/>
                    <measurement group_id="O2" value="0.4" spread="0.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Satisfaction (Fampridine-SR N=13, Placebo N=12)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="0.25"/>
                    <measurement group_id="O2" value="0.3" spread="0.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="0.47"/>
                    <measurement group_id="O2" value="-0.1" spread="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adjusted Mean Change in Subject Bladder/Bowel Function Diary Scores</title>
        <description>Bowel/bladder questions pertaining to the average number of times per day the patient experienced accidental urination/leakage and the average number of bowel movements per day were asked of all patients daily.&#xD;
A negative change in patient bladder/bowel function diary score signifies improvement.</description>
        <time_frame>Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98</time_frame>
        <population>ITT Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Fampridine-SR 50mg/Day</title>
            <description>Fampridine-SR : 25mg bid (twice daily)</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo : Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Adjusted Mean Change in Subject Bladder/Bowel Function Diary Scores</title>
          <description>Bowel/bladder questions pertaining to the average number of times per day the patient experienced accidental urination/leakage and the average number of bowel movements per day were asked of all patients daily.&#xD;
A negative change in patient bladder/bowel function diary score signifies improvement.</description>
          <population>ITT Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.</population>
          <units>episodes</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
                <count group_id="O2" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of Accidental Urination or Leakage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="0.20"/>
                    <measurement group_id="O2" value="-0.2" spread="0.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of Bowel Movements</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.03"/>
                    <measurement group_id="O2" value="-0.0" spread="0.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adjusted Mean Change in Subject Bowel Function Diary Scores</title>
        <description>Bowel questions pertaining to the average number of minutes per day spent on bowel routine were asked of all patients daily.&#xD;
A negative change in patient bowel function diary score signifies improvement.</description>
        <time_frame>Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98</time_frame>
        <population>ITT Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Fampridine-SR 50mg/Day</title>
            <description>Fampridine-SR : 25mg bid (twice daily)</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo : Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Adjusted Mean Change in Subject Bowel Function Diary Scores</title>
          <description>Bowel questions pertaining to the average number of minutes per day spent on bowel routine were asked of all patients daily.&#xD;
A negative change in patient bowel function diary score signifies improvement.</description>
          <population>ITT Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
                <count group_id="O2" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="0.90"/>
                    <measurement group_id="O2" value="0.3" spread="0.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Treatment-emergent adverse events (TEAE) include AEs with date of onset (or worsening) on or after the start of treatment and no more than 14 days after the last dose of investigational drug.</time_frame>
      <desc>Adverse events were recorded at every study visit. Results are presented for the Safety population defined as all randomized patients who received at least one dose of study treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Fampridine-SR 50mg/Day</title>
          <description>Fampridine-SR : 25mg bid (twice daily)</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo : Placebo</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>COSTART</default_vocab>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Coronary Artery Disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Myocardial Infarct</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Amblyopia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Intestinal Obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Hypothermia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accidental Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pathological Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Tendon Disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Dysautonomia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Neuropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Paresthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Speech Disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin Ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>COSTART</default_vocab>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="103"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Leukocvtosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="103"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="103"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Amblyopia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="103"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="103"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="103"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="5" subjects_at_risk="103"/>
                <counts group_id="E2" events="10" subjects_affected="5" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="7" subjects_affected="3" subjects_at_risk="103"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="103"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="103"/>
                <counts group_id="E2" events="9" subjects_affected="7" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="23" subjects_affected="19" subjects_at_risk="103"/>
                <counts group_id="E2" events="15" subjects_affected="14" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Peripheral Edema</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="103"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="9" subjects_affected="6" subjects_at_risk="103"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="33" subjects_affected="22" subjects_at_risk="103"/>
                <counts group_id="E2" events="22" subjects_affected="15" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="103"/>
                <counts group_id="E2" events="15" subjects_affected="15" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Flu Syndrome</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="103"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="103"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Fungal Dermatitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="103"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accidental Injury</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="103"/>
                <counts group_id="E2" events="22" subjects_affected="16" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="103"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </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" events="16" subjects_affected="10" subjects_at_risk="103"/>
                <counts group_id="E2" events="6" subjects_affected="3" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="103"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="103"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Neck Pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="103"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Neck Rigidity</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="103"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="103"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Paresthesia</sub_title>
                <counts group_id="E1" events="25" subjects_affected="18" subjects_at_risk="103"/>
                <counts group_id="E2" events="11" subjects_affected="9" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="20" subjects_affected="15" subjects_at_risk="103"/>
                <counts group_id="E2" events="11" subjects_affected="8" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="103"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="103"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Dysautonomia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="103"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Neuropathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="103"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertonia</sub_title>
                <counts group_id="E1" events="32" subjects_affected="24" subjects_at_risk="103"/>
                <counts group_id="E2" events="21" subjects_affected="17" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="17" subjects_affected="16" subjects_at_risk="103"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="103"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Nervousness</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="103"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Abnormal Dreams</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="103"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="103"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="23" subjects_affected="19" subjects_at_risk="103"/>
                <counts group_id="E2" events="12" subjects_affected="10" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Urinary Frequency</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="103"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Urinary Incontinence</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="103"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="103"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="103"/>
                <counts group_id="E2" events="6" subjects_affected="3" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Urine Abnormality</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="103"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Metrorrhagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="103"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Cough Increased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="103"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="103"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="103"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Skin Ulcer</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="103"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Sweating</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="103"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Photosensitivity Reaction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="103"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Maculopapular Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="103"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="103"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Vasodilatation</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="103"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="100"/>
              </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>Sponsor (Acorda) has right to review and comment on proposed publications within a specified time frame, up to 60 days; multi-center trials require joint publication unless specifically permitted otherwise.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Scientific Officer</name_or_title>
      <organization>Acorda Therapeutics, Inc.</organization>
      <phone>914-347-4300 ext 5102</phone>
      <email>ablight@acorda.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/NCT01683838
org study id: SCI-F302
nct id: NCT01683838
lead sponsor: 
has dmc: Yes
Normally, nerve fibers carry electrical impulses through the spinal cord, providing
      communication between the brain and the arms and legs. In people with spinal cord injury,
      some fibers may be destroyed at the site of injury, while others remain connected but do not
      work correctly to carry electrical impulses. As a result, subjects with an incomplete spinal
      cord injury may have spasticity which is muscle spasms or muscle stiffness that makes
      movement difficult. Fampridine-SR is an experimental drug that increases the ability of the
      nerve to conduct electrical impulses. This study will examine the effects of Fampridine-SR on
      moderate to severe lower-limb spasticity, as well as the effects on bodily functions such as
      bladder control, bowel function and sexual function. The study will also examine the possible
      risks of taking Fampridine-SR.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity
time frame: Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98
description: The Ashworth evaluates the functioning of two lower extremity muscle groups, the hamstring and quadriceps muscles, while in the supine position. The test measures extension of the right and left hamstring muscle and flexion of the right and left quadriceps muscle using the following 5-point grading scale:
1=no increased tone; 2=slight increase in tone, giving a "catch" when the affected part is moved in flexion or extension; 3=more marked increase in tone, but affected part is easily flexed; 4=considerable increase in tone, passive movement is difficult; 5=affected part is rigid in flexion and extension.
The Ashworth Score was determined by adding all individual scores for each muscle group and dividing by four. Higher Ashworth Scores indicated greater spasticity.
measure: Double-blind Change From Baseline in Mean Subject's Global Impression (SGI) Scores
time frame: Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98
description: The SGI is a 7-unit ordinal scale used by the subject to evaluate the effects of study medication on his/her quality of life during the preceding week, with higher scores denoting greater satisfaction. A positive change score in SGI signifies improved outcome.
The questionnaire consisted of one question (How do you feel about the effects of the investigational drug over the past 7 days?). The answer was based on a numerical rating scale where 1=terrible; 2=unhappy; 3=mostly dissatisfied; 4=neutral/mixed; 5=mostly satisfied; 6=pleased; 7=delighted.
measure: Double-blind Change From Baseline in Mean Spasm Frequency/Severity Scores
time frame: Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98
description: The Spasm Frequency score is the average rating by the clinician of the left and right arm(s) and leg(s), each evaluated on a 4-point scale (from 0=no spasms to 4=spontaneous spasms occurring more than ten times per hour), with higher scores denoting a greater degree of muscle spasms.
The Spasm Severity score is the average rating of the left and right arm(s) and leg(s), each evaluated on a three-point scale (mild, moderate, or severe) as rated by the clinician on the basis of patient self-report.
On both, a negative change in score signifies improvement in muscle spasms. The average Spasm Frequency/Spasm Severity Score was calculated as the average of the left and right non-missing scores.
measure: Double-blind Change From Baseline in Mean Clinician's Global Impression (CGI) Scores
time frame: Baseline (visits 2,3) average of days 7-14 and double-blind treatment period (visits 4-7) average of days 28-98)
description: The supervising clinician rated the patient's neurological condition following treatment as compared to the screening visit on a seven-point scale (from 1=very much improved to 7=very much worse). The assessment was based on the clinician's overall impression of the patient's neurological status (specifically bowel, bladder, and sexual function; spasticity; and other neurological functions) and general state of health related to his or her participation in the study. Negative change scores indicated a change for the better.
measure: Stable-dose Change From Baseline in Mean American Spinal Injury Association(ASIA) Total Motor Score
time frame: Baseline (visits 2,3) average score days 7,14 and stable-dose treatment period (visits 5-7) average score days 56-98
description: Ten key muscle groups for the right and left sides were rated on a 0 (absent) to 5 (normal) scale, with a possible total score of 100. Higher positive change scores indicate improved motor function.
measure: Change From Baseline in Mean International Index of Erectile Function (IIEF) Score
time frame: Baseline (visit 1) average score obtained at day 1 and stable treatment period (visit 7) average score day 98
description: Male patients were asked to complete the IIEF questionnaire on sexual function. The IIEF is a brief, reliable, and valid self-administered questionnaire of 15 questions (items) that were categorized into five domains: Erectile Function (EF) scores: 0-6 Severe dysfunction, 7-12 Moderate dysfunction, 13-18 Mild to moderate dysfunction, 19-24 Mild dysfunction, 25-30 No dysfunction. Orgasmic Function (OF) score range: 0-2 Severe dysfunction to 9-10 No dysfunction, Sexual Desire (SD) score range: 0-2 Severe dysfunction to 9-10 No dysfunction, Intercourse Satisfaction (IS) score range: 0-3 Severe dysfunction to 13-15 No dysfunction, and Overall Satisfaction (OS) score range: 0-2 Severe dysfunction to 9-10 No dysfunction.
Domain scores were derived by summing the individual items within a given domain. Final scale ranges from 0 (negative) to 5 (positive). A positive change in IIEF domain scores signifies improvement.
measure: Change From Baseline in Mean Female Sexual Function Index (FSFI) Scores
time frame: Baseline (visit 1) average score obtained at day 1 and stable treatment period (visits 4-7) average score days 28-98
description: The FSFI is a brief, reliable, and valid self-administered questionnaire of 19 questions (items). It contains six domains: Desire (2 items score range: 1 Very low or none at all to 5 Very high), Arousal (4 items score range: 0 No sexual activity to 5 Almost always or always), Lubrication (4 items score range: 0 No sexual activity to 5 Almost always or always), Orgasm (3 items score range: 0 No sexual activity to 5 Almost always or always), Satisfaction (3 items score range: 0 No sexual activity to 5 Very satisfied) and Pain (3 items score range: 0 Did not attempt intercourse to 5 Almost never or never).
A positive change signifies improvement.
measure: Adjusted Mean Change in Subject Bladder/Bowel Function Diary Scores
time frame: Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98
description: Bowel/bladder questions pertaining to the average number of times per day the patient experienced accidental urination/leakage and the average number of bowel movements per day were asked of all patients daily.
A negative change in patient bladder/bowel function diary score signifies improvement.
measure: Adjusted Mean Change in Subject Bowel Function Diary Scores
time frame: Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98
description: Bowel questions pertaining to the average number of minutes per day spent on bowel routine were asked of all patients daily.
A negative change in patient bowel function diary score signifies improvement.
arm group label: fampridine-SR 50mg/day
arm group type: Active Comparator
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Fampridine-SR
description: 25mg bid (twice daily)
arm group label: fampridine-SR 50mg/day
intervention type: Drug
intervention name: Placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Andrew Blight, MD
role: Study Director
affiliation: Acorda Therapeutics
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country: Canada
country: United States
url: http://www.acorda.com
description: Related Info
responsible party type: Sponsor
mesh term: Muscle Spasticity
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries
mesh term: 4-Aminopyridine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 