<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/NCT01716221</url>
  </required_header>
  <id_info>
    <org_study_id>11-1141</org_study_id>
    <nct_id>NCT01716221</nct_id>
  </id_info>
  <brief_title>An Objective Double-blind Evaluation of Bupropion and Citalopram in an Individual With Friedreich Ataxia</brief_title>
  <official_title>An Objective Double-blind Evaluation of Bupropion and Citalopram in an Individual With Friedreich Ataxia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to document the clinical effects of bupropion and citalopram in&#xD;
      a single subject with Friedreich Ataxia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a double blind study with a single subject to objectively document the clinical&#xD;
      effects of bupropion and citalopram in a single patient with Friedreich Ataxia (FA), whose&#xD;
      disorder symptoms have improved with the use of these medications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>International Cooperative Ataxia Rating Scale (ICARS)</measure>
    <time_frame>Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 weeks (bupropion), and 20 weeks (citalopram + bupropion)</time_frame>
    <description>The ICARS is a 19 item rating scale of ataxia with the total score ranging from 0 to 100. A score of 0 means normal and higher scores represent worsened disease.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Friedreich Ataxia Rating Scale (FARS)</measure>
    <time_frame>Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)</time_frame>
    <description>A rating scale developed for Friedreich ataxia in evaluation of ataxia. Score range from 0-159 with a score of 0 meaning normal and greater scores indicating worsened disease.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of FARS and ICARS</measure>
    <time_frame>Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)</time_frame>
    <description>Differences between FARS - ICARS at each treatment interval</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Hamilton Depression Rating Scale</measure>
    <time_frame>Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)</time_frame>
    <description>The Hamilton Depression Rating Scale is a 21 item questionnaire scored each item on a scale of 0 to 3 or 5. The max score is 66. Higher scores indicate worsened depression. All items are summed together to give a total score. A total score of 0-7 is considered normal, while total scores greater than 20 are indicative of moderate or greater depression.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Friedreich Ataxia</condition>
  <arm_group>
    <arm_group_label>Bupropion &amp; Citalopram</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100mg Bupropion &amp; 20mg Citalopram taken orally one time per day or 100mg Bupropion &amp; 10mg Citalopram taken orally one time per day or 50mg Bupropion &amp; 20mg Citalopram taken orally one time per day 0r 50mg Bupropion &amp; 10mg Citalopram taken orally one time per day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bupropion &amp; Placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>100mg Bupropion &amp; Placebo taken orally one time per day or 50mg Bupropion &amp; Placebo taken orally one time per day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo &amp; Citalopram</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Placebo &amp; 20mg Citalopram taken orally one time per day or Placebo &amp; 10mg Citalopram taken orally one time per day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo &amp; Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo &amp; Placebo taken orally one time per day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>bupropion &amp; Citalopram</intervention_name>
    <arm_group_label>Bupropion &amp; Citalopram</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupropion &amp; Placebo</intervention_name>
    <arm_group_label>Bupropion &amp; Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo &amp; Citalopram</intervention_name>
    <arm_group_label>Placebo &amp; Citalopram</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo &amp; Placebo</intervention_name>
    <arm_group_label>Placebo &amp; Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Friedreich Ataxia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to provide Informed Consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Olga Klepitskaya, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <results_first_submitted>March 11, 2016</results_first_submitted>
  <results_first_submitted_qc>July 27, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">September 19, 2016</results_first_posted>
  <last_update_submitted>July 27, 2016</last_update_submitted>
  <last_update_submitted_qc>July 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ataxia</mesh_term>
    <mesh_term>Cerebellar Ataxia</mesh_term>
    <mesh_term>Friedreich Ataxia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexetimide</mesh_term>
    <mesh_term>Bupropion</mesh_term>
    <mesh_term>Citalopram</mesh_term>
    <mesh_term>Escitalopram</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Study Participant</title>
          <description>the participant received all intervention combinations in the following order: bupropion &amp; Citalopram, then Bupropion &amp; Placebo, then Placebo &amp; Citalopram, then Placebo &amp; 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="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Study Participant</title>
          <description>the participant received all intervention combinations in the following order: bupropion &amp; Citalopram, then Bupropion &amp; Placebo, then Placebo &amp; Citalopram, then Placebo &amp; Placebo</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65" spread="0"/>
                  </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="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>International Cooperative Ataxia Rating Scale (ICARS)</title>
        <description>The ICARS is a 19 item rating scale of ataxia with the total score ranging from 0 to 100. A score of 0 means normal and higher scores represent worsened disease.</description>
        <time_frame>Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 weeks (bupropion), and 20 weeks (citalopram + bupropion)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupropion &amp; Citalopram</title>
            <description>100mg Bupropion &amp; 20mg Citalopram taken orally one time per day or 100mg Bupropion &amp; 10mg Citalopram taken orally one time per day or 50mg Bupropion &amp; 20mg Citalopram taken orally one time per day or 50mg Bupropion &amp; 10mg Citalopram taken orally one time per day&#xD;
bupropion &amp; Citalopram</description>
          </group>
          <group group_id="O2">
            <title>Bupropion &amp; Placebo</title>
            <description>100mg Bupropion &amp; Placebo taken orally one time per day or 50mg Bupropion &amp; Placebo taken orally one time per day&#xD;
Bupropion &amp; Placebo</description>
          </group>
          <group group_id="O3">
            <title>Placebo &amp; Citalopram</title>
            <description>Placebo &amp; 20mg Citalopram taken orally one time per day or Placebo &amp; 10mg Citalopram taken orally one time per day&#xD;
Placebo &amp; Citalopram</description>
          </group>
          <group group_id="O4">
            <title>Placebo &amp; Placebo</title>
            <description>Placebo &amp; Placebo taken orally one time per day&#xD;
Placebo &amp; Placebo</description>
          </group>
          <group group_id="O5">
            <title>Baseline</title>
            <description>unblinded 100mg Bupropion &amp; 20mg Citalopram</description>
          </group>
        </group_list>
        <measure>
          <title>International Cooperative Ataxia Rating Scale (ICARS)</title>
          <description>The ICARS is a 19 item rating scale of ataxia with the total score ranging from 0 to 100. A score of 0 means normal and higher scores represent worsened disease.</description>
          <units>units</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="1"/>
                <count group_id="O5" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="30"/>
                    <measurement group_id="O3" value="47"/>
                    <measurement group_id="O4" value="46"/>
                    <measurement group_id="O5" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Friedreich Ataxia Rating Scale (FARS)</title>
        <description>A rating scale developed for Friedreich ataxia in evaluation of ataxia. Score range from 0-159 with a score of 0 meaning normal and greater scores indicating worsened disease.</description>
        <time_frame>Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Baseline - Unblinded on Buproprion and Citalopram</title>
          </group>
          <group group_id="O2">
            <title>Citalopram (Week 5)</title>
          </group>
          <group group_id="O3">
            <title>OFF - Bupropion Placebo + Citalopram Placebo (Week 10)</title>
          </group>
          <group group_id="O4">
            <title>Bupropion Only (Week 15)</title>
          </group>
          <group group_id="O5">
            <title>Bupropion + Citalopram (Week 20)</title>
          </group>
        </group_list>
        <measure>
          <title>Friedreich Ataxia Rating Scale (FARS)</title>
          <description>A rating scale developed for Friedreich ataxia in evaluation of ataxia. Score range from 0-159 with a score of 0 meaning normal and greater scores indicating worsened disease.</description>
          <units>points</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="1"/>
                <count group_id="O5" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="41"/>
                    <measurement group_id="O3" value="47"/>
                    <measurement group_id="O4" value="42"/>
                    <measurement group_id="O5" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Comparison of FARS and ICARS</title>
        <description>Differences between FARS - ICARS at each treatment interval</description>
        <time_frame>Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Baseline - Unblinded on Buproprion and Citalopram</title>
          </group>
          <group group_id="O2">
            <title>Citalopram (Week 5)</title>
          </group>
          <group group_id="O3">
            <title>OFF - Bupropion Placebo + Citalopram Placebo (Week 10)</title>
          </group>
          <group group_id="O4">
            <title>Bupropion Only (Week 15)</title>
          </group>
          <group group_id="O5">
            <title>Bupropion + Citalopram (Week 20)</title>
          </group>
        </group_list>
        <measure>
          <title>Comparison of FARS and ICARS</title>
          <description>Differences between FARS - ICARS at each treatment interval</description>
          <units>points</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="1"/>
                <count group_id="O5" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="-6"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="12"/>
                    <measurement group_id="O5" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Hamilton Depression Rating Scale</title>
        <description>The Hamilton Depression Rating Scale is a 21 item questionnaire scored each item on a scale of 0 to 3 or 5. The max score is 66. Higher scores indicate worsened depression. All items are summed together to give a total score. A total score of 0-7 is considered normal, while total scores greater than 20 are indicative of moderate or greater depression.</description>
        <time_frame>Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Baseline - Unblinded on Buproprion and Citalopram</title>
          </group>
          <group group_id="O2">
            <title>Citalopram (Week 5)</title>
          </group>
          <group group_id="O3">
            <title>OFF - Bupropion Placebo + Citalopram Placebo (Week 10)</title>
          </group>
          <group group_id="O4">
            <title>Bupropion Only (Week 15)</title>
          </group>
          <group group_id="O5">
            <title>Bupropion + Citalopram (Week 20)</title>
          </group>
        </group_list>
        <measure>
          <title>Hamilton Depression Rating Scale</title>
          <description>The Hamilton Depression Rating Scale is a 21 item questionnaire scored each item on a scale of 0 to 3 or 5. The max score is 66. Higher scores indicate worsened depression. All items are summed together to give a total score. A total score of 0-7 is considered normal, while total scores greater than 20 are indicative of moderate or greater depression.</description>
          <units>units on a scale</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="1"/>
                <count group_id="O5" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Bupropion &amp; Citalopram</title>
          <description>100mg Bupropion &amp; 20mg Citalopram taken orally one time per day or 100mg Bupropion &amp; 10mg Citalopram taken orally one time per day or 50mg Bupropion &amp; 20mg Citalopram taken orally one time per day 0r 50mg Bupropion &amp; 10mg Citalopram taken orally one time per day&#xD;
bupropion &amp; Citalopram</description>
        </group>
        <group group_id="E2">
          <title>Bupropion &amp; Placebo</title>
          <description>100mg Bupropion &amp; Placebo taken orally one time per day or 50mg Bupropion &amp; Placebo taken orally one time per day&#xD;
Bupropion &amp; Placebo</description>
        </group>
        <group group_id="E3">
          <title>Placebo &amp; Citalopram</title>
          <description>Placebo &amp; 20mg Citalopram taken orally one time per day or Placebo &amp; 10mg Citalopram taken orally one time per day&#xD;
Placebo &amp; Citalopram</description>
        </group>
        <group group_id="E4">
          <title>Placebo &amp; Placebo</title>
          <description>Placebo &amp; Placebo taken orally one time per day&#xD;
Placebo &amp; Placebo</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Olga Klepitskaya</name_or_title>
      <organization>University of Colorado</organization>
      <phone>303-724-8984</phone>
      <email>olga.klepitskaya@ucdenver.edu</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/NCT01716221
org study id: 11-1141
nct id: NCT01716221
lead sponsor: 
The purpose of this study is to document the clinical effects of bupropion and citalopram in
      a single subject with Friedreich Ataxia.
This is a double blind study with a single subject to objectively document the clinical
      effects of bupropion and citalopram in a single patient with Friedreich Ataxia (FA), whose
      disorder symptoms have improved with the use of these medications.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: International Cooperative Ataxia Rating Scale (ICARS)
time frame: Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 weeks (bupropion), and 20 weeks (citalopram + bupropion)
description: The ICARS is a 19 item rating scale of ataxia with the total score ranging from 0 to 100. A score of 0 means normal and higher scores represent worsened disease.
measure: Friedreich Ataxia Rating Scale (FARS)
time frame: Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)
description: A rating scale developed for Friedreich ataxia in evaluation of ataxia. Score range from 0-159 with a score of 0 meaning normal and greater scores indicating worsened disease.
measure: Comparison of FARS and ICARS
time frame: Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)
description: Differences between FARS - ICARS at each treatment interval
measure: Hamilton Depression Rating Scale
time frame: Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)
description: The Hamilton Depression Rating Scale is a 21 item questionnaire scored each item on a scale of 0 to 3 or 5. The max score is 66. Higher scores indicate worsened depression. All items are summed together to give a total score. A total score of 0-7 is considered normal, while total scores greater than 20 are indicative of moderate or greater depression.
arm group label: Bupropion & Citalopram
arm group type: Experimental
description: 100mg Bupropion & 20mg Citalopram taken orally one time per day or 100mg Bupropion & 10mg Citalopram taken orally one time per day or 50mg Bupropion & 20mg Citalopram taken orally one time per day 0r 50mg Bupropion & 10mg Citalopram taken orally one time per day
arm group label: Bupropion & Placebo
arm group type: Active Comparator
description: 100mg Bupropion & Placebo taken orally one time per day or 50mg Bupropion & Placebo taken orally one time per day
arm group label: Placebo & Citalopram
arm group type: Active Comparator
description: Placebo & 20mg Citalopram taken orally one time per day or Placebo & 10mg Citalopram taken orally one time per day
arm group label: Placebo & Placebo
arm group type: Placebo Comparator
description: Placebo & Placebo taken orally one time per day
intervention type: Drug
intervention name: bupropion & Citalopram
arm group label: Bupropion & Citalopram
intervention type: Drug
intervention name: Bupropion & Placebo
arm group label: Bupropion & Placebo
intervention type: Drug
intervention name: Placebo & Citalopram
arm group label: Placebo & Citalopram
intervention type: Drug
intervention name: Placebo & Placebo
arm group label: Placebo & Placebo
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Olga Klepitskaya, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
responsible party type: Sponsor
mesh term: Ataxia
mesh term: Cerebellar Ataxia
mesh term: Friedreich Ataxia
mesh term: Dexetimide
mesh term: Bupropion
mesh term: Citalopram
mesh term: Escitalopram
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 