<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/NCT03236662</url>
  </required_header>
  <id_info>
    <org_study_id>767161</org_study_id>
    <nct_id>NCT03236662</nct_id>
  </id_info>
  <brief_title>(-)- Epicatechin Becker Muscular Dystrophy</brief_title>
  <official_title>UCD0115B: An Open-label Extension Study of Purified Epicatechin to Improve Mitochondrial Function, Strength and Skeletal Muscle Exercise Response in Becker Muscular Dystrophy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Craig McDonald, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cardero Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Davis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a 48-week open-label extension of our initial proof-of-concept study (UCD0113) in&#xD;
      patients with Becker muscular dystrophy who participated in the earlier trial. This single&#xD;
      center study will enroll up to 10 adults who will receive the purified nutritional extract&#xD;
      (-)-epicatechin 100mg/day orally for 8 weeks. After screening visits, participants will be&#xD;
      enrolled in the study if they meet all inclusion criteria. They will be evaluated at&#xD;
      screening, baseline, and weeks 4, 8, 12, 24, 16 and 48. The main criterion for success of the&#xD;
      study will be presence of one or more biologic or strength and performance outcome measures&#xD;
      that yield a response magnitude that allows for sufficient power in a Phase II B study with a&#xD;
      sample size of 30 individuals.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">November 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma Follistatin</measure>
    <time_frame>48 weeks</time_frame>
    <description>blood biomarker concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Myostatin</measure>
    <time_frame>48 weeks</time_frame>
    <description>blood biomarker concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Nitrates/ SNO</measure>
    <time_frame>48 weeks</time_frame>
    <description>blood biomarker concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma BNP</measure>
    <time_frame>48 weeks</time_frame>
    <description>blood biomarker concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Creatine Kinase</measure>
    <time_frame>48 weeks</time_frame>
    <description>blood biomarker concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma MMP-9</measure>
    <time_frame>48 weeks</time_frame>
    <description>blood biomarker concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma TNF-Alpha</measure>
    <time_frame>48 weeks</time_frame>
    <description>blood biomarker concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma TGF-Beta</measure>
    <time_frame>48 weeks</time_frame>
    <description>blood biomarker concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Follistatin:Myostain Ratio</measure>
    <time_frame>48 weeks</time_frame>
    <description>Ratio of plasma follistatin to plasma myostatin</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Graded Exercise Test Using a Recumbent Cycle Ergometer</measure>
    <time_frame>baseline and at 2-minute intervals</time_frame>
    <description>blood lactate measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-minute Walk Test</measure>
    <time_frame>48 weeks</time_frame>
    <description>Measurements recorded will include 25-meter split times and total distance traveled.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Exploratory Proteomics</measure>
    <time_frame>48 weeks</time_frame>
    <description>Collection of plasma samples for proteomics analysis.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Becker Muscular Dystrophy</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>(-)-epicatechin 50mg twice per day (100mg per day total dose)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>(-)-Epicatechin</intervention_name>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Prior participation in UCD0113 BMD epicatechin pilot study&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  Age 18 years to 70 years&#xD;
&#xD;
          -  Average to low daily physical activity&#xD;
&#xD;
          -  Ability to ambulate for 75 meters without assistive devices&#xD;
&#xD;
          -  Diagnosis of BMD confirmed by at least one the following:&#xD;
&#xD;
          -  Dystrophin immunofluorescence and/or immunoblot showing partial dystrophin deficiency,&#xD;
             and clinical picture consistent with typical BMD, or&#xD;
&#xD;
          -  Gene deletions test positive (missing one or more exons) of the dystrophin gene, where&#xD;
             reading frame can be predicted as 'in-frame', and clinical picture consistent with&#xD;
             typical BMD, or&#xD;
&#xD;
          -  Complete dystrophin gene sequencing showing an alteration (point mutation,&#xD;
             duplication, or other mutation resulting in a stop codon mutation) that can be&#xD;
             definitely associated with BMD, with a typical clinical picture of BMD, or&#xD;
&#xD;
          -  Positive family history of BMD confirmed by one of the criteria listed above in a&#xD;
             sibling or maternal uncle, and clinical picture typical of BMD.&#xD;
&#xD;
          -  Hematology profile within normal range&#xD;
&#xD;
          -  Baseline laboratory safety chemistry profile within normal range&#xD;
&#xD;
          -  No plan to change exercise regimen during study participation&#xD;
&#xD;
          -  Nutritional, herbal and antioxidant supplements taken with the intent of maintaining&#xD;
             or improving skeletal muscle strength or functional mobility have been discontinued at&#xD;
             least 2 weeks prior to screening (daily multivitamin use is acceptable).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently enrolled in another treatment clinical trial.&#xD;
&#xD;
          -  History of significant concomitant illness or significant impairment of renal or&#xD;
             hepatic function.&#xD;
&#xD;
          -  Use of regular daily aspirin or other medication with antiplatelet effects within 3&#xD;
             weeks of first dose of study medication.&#xD;
&#xD;
          -  Regular participation in vigorous exercise.&#xD;
&#xD;
          -  Symptomatic heart failure with cardiac ejection fraction &lt;25%&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UC Davis Medical Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>November 7, 2016</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <results_first_submitted>April 6, 2021</results_first_submitted>
  <results_first_submitted_qc>July 1, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 26, 2021</results_first_posted>
  <last_update_submitted>November 22, 2021</last_update_submitted>
  <last_update_submitted_qc>November 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Davis</investigator_affiliation>
    <investigator_full_name>Craig McDonald, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>BMD</keyword>
  <keyword>Becker muscular dystrophy</keyword>
  <keyword>epicatechin</keyword>
  <keyword>clinical trial</keyword>
  <keyword>neuromuscular disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscular Dystrophies</mesh_term>
    <mesh_term>Muscular Dystrophy, Duchenne</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 15, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/62/NCT03236662/Prot_SAP_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 20, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/62/NCT03236662/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Treatment</title>
          <description>(-)-epicatechin 50mg twice per day (100mg per day total dose)&#xD;
(-)-Epicatechin</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </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>Treatment</title>
          <description>(-)-epicatechin 50mg twice per day (100mg per day total dose)&#xD;
(-)-Epicatechin</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="2"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54" lower_limit="52" upper_limit="56"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Plasma Follistatin</title>
        <description>blood biomarker concentration</description>
        <time_frame>48 weeks</time_frame>
        <population>Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>(-)-epicatechin 50mg twice per day (100mg per day total dose)&#xD;
(-)-Epicatechin</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Follistatin</title>
          <description>blood biomarker concentration</description>
          <population>Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Plasma Myostatin</title>
        <description>blood biomarker concentration</description>
        <time_frame>48 weeks</time_frame>
        <population>Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>(-)-epicatechin 50mg twice per day (100mg per day total dose)&#xD;
(-)-Epicatechin</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Myostatin</title>
          <description>blood biomarker concentration</description>
          <population>Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Plasma Nitrates/ SNO</title>
        <description>blood biomarker concentration</description>
        <time_frame>48 weeks</time_frame>
        <population>Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>(-)-epicatechin 50mg twice per day (100mg per day total dose)&#xD;
(-)-Epicatechin</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Nitrates/ SNO</title>
          <description>blood biomarker concentration</description>
          <population>Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Plasma BNP</title>
        <description>blood biomarker concentration</description>
        <time_frame>48 weeks</time_frame>
        <population>Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>(-)-epicatechin 50mg twice per day (100mg per day total dose)&#xD;
(-)-Epicatechin</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma BNP</title>
          <description>blood biomarker concentration</description>
          <population>Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Plasma Creatine Kinase</title>
        <description>blood biomarker concentration</description>
        <time_frame>48 weeks</time_frame>
        <population>Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>(-)-epicatechin 50mg twice per day (100mg per day total dose)&#xD;
(-)-Epicatechin</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Creatine Kinase</title>
          <description>blood biomarker concentration</description>
          <population>Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Plasma MMP-9</title>
        <description>blood biomarker concentration</description>
        <time_frame>48 weeks</time_frame>
        <population>Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>(-)-epicatechin 50mg twice per day (100mg per day total dose)&#xD;
(-)-Epicatechin</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma MMP-9</title>
          <description>blood biomarker concentration</description>
          <population>Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Plasma TNF-Alpha</title>
        <description>blood biomarker concentration</description>
        <time_frame>48 weeks</time_frame>
        <population>Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>(-)-epicatechin 50mg twice per day (100mg per day total dose)&#xD;
(-)-Epicatechin</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma TNF-Alpha</title>
          <description>blood biomarker concentration</description>
          <population>Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Plasma TGF-Beta</title>
        <description>blood biomarker concentration</description>
        <time_frame>48 weeks</time_frame>
        <population>Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>(-)-epicatechin 50mg twice per day (100mg per day total dose)&#xD;
(-)-Epicatechin</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma TGF-Beta</title>
          <description>blood biomarker concentration</description>
          <population>Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Plasma Follistatin:Myostain Ratio</title>
        <description>Ratio of plasma follistatin to plasma myostatin</description>
        <time_frame>48 weeks</time_frame>
        <population>Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>(-)-epicatechin 50mg twice per day (100mg per day total dose)&#xD;
(-)-Epicatechin</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Follistatin:Myostain Ratio</title>
          <description>Ratio of plasma follistatin to plasma myostatin</description>
          <population>Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Graded Exercise Test Using a Recumbent Cycle Ergometer</title>
        <description>blood lactate measured</description>
        <time_frame>baseline and at 2-minute intervals</time_frame>
        <population>Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>(-)-epicatechin 50mg twice per day (100mg per day total dose)&#xD;
(-)-Epicatechin</description>
          </group>
        </group_list>
        <measure>
          <title>Graded Exercise Test Using a Recumbent Cycle Ergometer</title>
          <description>blood lactate measured</description>
          <population>Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>6-minute Walk Test</title>
        <description>Measurements recorded will include 25-meter split times and total distance traveled.</description>
        <time_frame>48 weeks</time_frame>
        <population>Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>(-)-epicatechin 50mg twice per day (100mg per day total dose)&#xD;
(-)-Epicatechin</description>
          </group>
        </group_list>
        <measure>
          <title>6-minute Walk Test</title>
          <description>Measurements recorded will include 25-meter split times and total distance traveled.</description>
          <population>Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Exploratory Proteomics</title>
        <description>Collection of plasma samples for proteomics analysis.</description>
        <time_frame>48 weeks</time_frame>
        <population>Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>(-)-epicatechin 50mg twice per day (100mg per day total dose)&#xD;
(-)-Epicatechin</description>
          </group>
        </group_list>
        <measure>
          <title>Exploratory Proteomics</title>
          <description>Collection of plasma samples for proteomics analysis.</description>
          <population>Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>48 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Treatment</title>
          <description>(-)-epicatechin 50mg twice per day (100mg per day total dose)&#xD;
(-)-Epicatechin</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
              </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="2"/>
              </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>
    <limitations_and_caveats>Small number of subjects analyzed.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Craig McDonald, Professor and Chair</name_or_title>
      <organization>UC Davis Health</organization>
      <phone>(916) 734-4293</phone>
      <email>cmmcdonald@ucdavis.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/NCT03236662
org study id: 767161
nct id: NCT03236662
lead sponsor: 
collaborator: 
has dmc: No
This is a 48-week open-label extension of our initial proof-of-concept study (UCD0113) in
      patients with Becker muscular dystrophy who participated in the earlier trial. This single
      center study will enroll up to 10 adults who will receive the purified nutritional extract
      (-)-epicatechin 100mg/day orally for 8 weeks. After screening visits, participants will be
      enrolled in the study if they meet all inclusion criteria. They will be evaluated at
      screening, baseline, and weeks 4, 8, 12, 24, 16 and 48. The main criterion for success of the
      study will be presence of one or more biologic or strength and performance outcome measures
      that yield a response magnitude that allows for sufficient power in a Phase II B study with a
      sample size of 30 individuals.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Plasma Follistatin
time frame: 48 weeks
description: blood biomarker concentration
measure: Plasma Myostatin
time frame: 48 weeks
description: blood biomarker concentration
measure: Plasma Nitrates/ SNO
time frame: 48 weeks
description: blood biomarker concentration
measure: Plasma BNP
time frame: 48 weeks
description: blood biomarker concentration
measure: Plasma Creatine Kinase
time frame: 48 weeks
description: blood biomarker concentration
measure: Plasma MMP-9
time frame: 48 weeks
description: blood biomarker concentration
measure: Plasma TNF-Alpha
time frame: 48 weeks
description: blood biomarker concentration
measure: Plasma TGF-Beta
time frame: 48 weeks
description: blood biomarker concentration
measure: Plasma Follistatin:Myostain Ratio
time frame: 48 weeks
description: Ratio of plasma follistatin to plasma myostatin
measure: Graded Exercise Test Using a Recumbent Cycle Ergometer
time frame: baseline and at 2-minute intervals
description: blood lactate measured
measure: 6-minute Walk Test
time frame: 48 weeks
description: Measurements recorded will include 25-meter split times and total distance traveled.
measure: Exploratory Proteomics
time frame: 48 weeks
description: Collection of plasma samples for proteomics analysis.
arm group label: Treatment
arm group type: Experimental
description: (-)-epicatechin 50mg twice per day (100mg per day total dose)
intervention type: Drug
intervention name: (-)-Epicatechin
arm group label: Treatment
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of California, Davis
investigator full name: Craig McDonald, MD
investigator title: Principal Investigator
mesh term: Muscular Dystrophies
mesh term: Muscular Dystrophy, Duchenne
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Small number of subjects analyzed.
point of contact: 