<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/NCT04406649</url>
  </required_header>
  <id_info>
    <org_study_id>STS101-003</org_study_id>
    <nct_id>NCT04406649</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety of STS101 in the Acute Treatment of Migraine</brief_title>
  <acronym>ASCEND</acronym>
  <official_title>An Open-Label, 12-Month Study to Evaluate the Safety and Tolerability of STS101 (Dihydroergotamine Nasal Powder) in the Acute Treatment of Migraine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Satsuma Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Satsuma Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study STS101-003 is a multi-center, multiple dose (PRN), open-label, 12-month study to&#xD;
      evaluate the safety and tolerability of STS101 (dihydroergotamine nasal powder) in the acute&#xD;
      treatment of migraine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The ASCEND trial is a multi-center, multiple dose (PRN), open-label, 12-month study to&#xD;
      evaluate the safety and tolerability of STS101 (dihydroergotamine nasal powder) in the acute&#xD;
      treatment of migraine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 14, 2020</start_date>
  <completion_date type="Actual">January 16, 2023</completion_date>
  <primary_completion_date type="Actual">January 16, 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Attacks With Sustained Freedom From Headache Pain 2-48 Hours (Modified Intent to Treat Population)</measure>
    <time_frame>At Month 12 of Study Medication Dosing</time_frame>
    <description>The subject's rating was documented on a four-point scale from no pain (= 0), mild pain (= 1), moderate pain (= 2) to severe pain (= 3). Pain freedom means the pain went from moderate (2) or severe (3) to no pain (0).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Attacks With Sustained Freedom From Most Bothersome Symptom 2-48 Hours (Modified Intent to Treat Population)</measure>
    <time_frame>At Month 12 of Study Drug Administration</time_frame>
    <description>Subjects were prompted to document the presence of 3 symptoms (photophobia, phonophobia, and nausea) immediately before study drug administration and during the treated migraine attack.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">482</enrollment>
  <condition>Migraine</condition>
  <condition>Migraine With Aura</condition>
  <condition>Migraine Without Aura</condition>
  <arm_group>
    <arm_group_label>STS101</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>STS101 (dihydroergotamine nasal powder)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dihydroergotamine</intervention_name>
    <description>Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.</description>
    <arm_group_label>STS101</arm_group_label>
    <other_name>Dihydroergotamine Mesylate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Males or females, 18-65 years of age at the time of Screening Visit&#xD;
&#xD;
          -  Subject has at least 1-year history of migraines (with or without aura), according to&#xD;
             the&#xD;
&#xD;
          -  International Classification of Headache Disorder, 3rd Edition (ICHD3)&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
&#xD;
          -  Women of child-bearing potential not using or not willing to use highly effective&#xD;
             contraception.&#xD;
&#xD;
          -  Diagnosis of headache conditions other than migraine with or without aura, including&#xD;
             diagnosis of basilar or hemiplegic migraines or cluster headache.&#xD;
&#xD;
          -  History of coronary artery disease, coronary artery vasospasm (including&#xD;
             Printz-metals' angina), clinically significant arrhythmia or, peripheral vascular&#xD;
             disease, ischemic disease (e.g. Raynaud's syndrome, ischemic bowel syndrome, angina&#xD;
             pectoris, myocardial infarction, or documented silent ischemia); percutaneous coronary&#xD;
             intervention, or cardiac surgery.&#xD;
&#xD;
          -  History of cerebrovascular disease, including but not limited to stroke, transient&#xD;
             ischemic attack, cerebral hemorrhage, subarachnoid hemorrhage.&#xD;
&#xD;
          -  Diagnosis of major depression with current symptoms, psychosis, alcohol abuse or&#xD;
             dependence, drug abuse or dependence, major psychiatric conditions (e.g.&#xD;
             schizophrenia, psychosis or Bipolar disorder), dementia. Other significant&#xD;
             neurological or psychiatric disorders (including other pain syndromes or risk of&#xD;
             suicide) that in the opinion of the investigator might interfere with study&#xD;
             participation and assessments or subject safety.&#xD;
&#xD;
          -  Any clinically significant symptoms or conditions, including but not limited to&#xD;
             central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic&#xD;
             or gastrointestinal conditions or history of such conditions that, in the opinion of&#xD;
             the investigator might interfere with study assessments or safety of participant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Detlef Albrecht, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Satsuma Pharmaceuticals, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>WR-PRI</name>
      <address>
        <city>Encino</city>
        <state>California</state>
        <zip>91316</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Collaborative Neuroscience</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WR-PRI</name>
      <address>
        <city>Los Alamitos</city>
        <state>California</state>
        <zip>90720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Downtown LA Research</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Institute</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WR-PRI</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hillcrest Medical Research</name>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Clinical</name>
      <address>
        <city>Hallandale Beach</city>
        <state>Florida</state>
        <zip>33009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multi-Specialty Research Associates</name>
      <address>
        <city>Lake City</city>
        <state>Florida</state>
        <zip>32055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ClinCloud</name>
      <address>
        <city>Maitland</city>
        <state>Florida</state>
        <zip>32751</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Behavioral Clinical Research</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33061</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Biotech Pharmaceuticals</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CNS Health Care - Orlando</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complete Health Research</name>
      <address>
        <city>Ormond Beach</city>
        <state>Florida</state>
        <zip>32174</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Infinity Clinical Research</name>
      <address>
        <city>Sunrise</city>
        <state>Florida</state>
        <zip>33351</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santos Research Center, Corp</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palm Beach Research Center</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33409</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research CF</name>
      <address>
        <city>Winter Haven</city>
        <state>Florida</state>
        <zip>33880</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Clinical Research</name>
      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <zip>83642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Integrated Clinical Trial Services, Inc</name>
      <address>
        <city>West Des Moines</city>
        <state>Iowa</state>
        <zip>50265</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delricht Research</name>
      <address>
        <city>Prairieville</city>
        <state>Louisiana</state>
        <zip>70769</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medvadis Research at Boston PainCare Center</name>
      <address>
        <city>Waltham</city>
        <state>Massachusetts</state>
        <zip>02451</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Healthcare Research Network</name>
      <address>
        <city>Hazelwood</city>
        <state>Missouri</state>
        <zip>63042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinvest Research</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montana Medical Research</name>
      <address>
        <city>Missoula</city>
        <state>Montana</state>
        <zip>59808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Research - Clinical Research Center of Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock Neurology Headache Clinic</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03766</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hassman Research Institute</name>
      <address>
        <city>Berlin</city>
        <state>New Jersey</state>
        <zip>08009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albuquerque Clinical Trials</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SPRI Clinical Research</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PharmQuest</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27408</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Wilmington</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CTI Clinical Research Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rapid Medical Research</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurology Diagnosis</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45459</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delricht Research</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74133</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University/Jefferson Headache Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omega Medical Research</name>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <zip>02886</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CNS Healthcare - Memphis</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FutureSearch Trials of Neurology</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DM Clinical Research</name>
      <address>
        <city>Tomball</city>
        <state>Texas</state>
        <zip>77375</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charlottesville Medical Research</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgetown University Hospital, Department of Neurology</name>
      <address>
        <city>McLean</city>
        <state>Virginia</state>
        <zip>22101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <results_first_submitted>June 12, 2023</results_first_submitted>
  <results_first_submitted_qc>June 30, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">July 3, 2023</results_first_posted>
  <last_update_submitted>June 30, 2023</last_update_submitted>
  <last_update_submitted_qc>June 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>dihydroergotamine</keyword>
  <keyword>dihydroergotamine mesylate</keyword>
  <keyword>migraine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
    <mesh_term>Migraine without Aura</mesh_term>
    <mesh_term>Migraine with Aura</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dihydroergotamine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 24, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/49/NCT04406649/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 19, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/49/NCT04406649/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted at 54 sites in the United States.</recruitment_details>
      <pre_assignment_details>A total of 482 participants were enrolled in the study (all enrolled subjects population).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>STS101 5.2 mg</title>
          <description>Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 5.2 mg.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="482"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="205"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="277"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The data are from All Subjects (Mk1/Mk2 device) Safety Population.</population>
      <group_list>
        <group group_id="B1">
          <title>STS101 5.2 mg</title>
          <description>Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 5.2 mg.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="446"/>
          </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="39.1" spread="10.8"/>
                  </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="389"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="379"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </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="446"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Attacks With Sustained Freedom From Headache Pain 2-48 Hours (Modified Intent to Treat Population)</title>
        <description>The subject's rating was documented on a four-point scale from no pain (= 0), mild pain (= 1), moderate pain (= 2) to severe pain (= 3). Pain freedom means the pain went from moderate (2) or severe (3) to no pain (0).</description>
        <time_frame>At Month 12 of Study Medication Dosing</time_frame>
        <group_list>
          <group group_id="O1">
            <title>STS101 5.2 mg</title>
            <description>Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 5.2 mg.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Attacks With Sustained Freedom From Headache Pain 2-48 Hours (Modified Intent to Treat Population)</title>
          <description>The subject's rating was documented on a four-point scale from no pain (= 0), mild pain (= 1), moderate pain (= 2) to severe pain (= 3). Pain freedom means the pain went from moderate (2) or severe (3) to no pain (0).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="183"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Attacks With Sustained Freedom From Most Bothersome Symptom 2-48 Hours (Modified Intent to Treat Population)</title>
        <description>Subjects were prompted to document the presence of 3 symptoms (photophobia, phonophobia, and nausea) immediately before study drug administration and during the treated migraine attack.</description>
        <time_frame>At Month 12 of Study Drug Administration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>STS101 5.2 mg</title>
            <description>Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 5.2 mg.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Attacks With Sustained Freedom From Most Bothersome Symptom 2-48 Hours (Modified Intent to Treat Population)</title>
          <description>Subjects were prompted to document the presence of 3 symptoms (photophobia, phonophobia, and nausea) immediately before study drug administration and during the treated migraine attack.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="183"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected for 1 year.</time_frame>
      <desc>The all subjects (Mk1/Mk2 device) safety population was used for adverse event reporting.</desc>
      <group_list>
        <group group_id="E1">
          <title>STS101 5.2 mg</title>
          <description>Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 5.2 mg.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="446"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="446"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="446"/>
              </event>
              <event>
                <sub_title>Postural Orthostatic Tachycardia Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="446"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis Acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="446"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="206" subjects_at_risk="446"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="446"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="446"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="446"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nasal Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="64" subjects_at_risk="446"/>
              </event>
              <event>
                <sub_title>Nasal Congestion</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="446"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="446"/>
              </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>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Vice President of Regulatory Affairs and Quality</name_or_title>
      <organization>Satsuma Pharmaceuticals, Inc.</organization>
      <phone>650-837-0799</phone>
      <email>clin.inquiries@satsumarx.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/NCT04406649
org study id: STS101-003
nct id: NCT04406649
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Study STS101-003 is a multi-center, multiple dose (PRN), open-label, 12-month study to
      evaluate the safety and tolerability of STS101 (dihydroergotamine nasal powder) in the acute
      treatment of migraine.
The ASCEND trial is a multi-center, multiple dose (PRN), open-label, 12-month study to
      evaluate the safety and tolerability of STS101 (dihydroergotamine nasal powder) in the acute
      treatment of migraine.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Attacks With Sustained Freedom From Headache Pain 2-48 Hours (Modified Intent to Treat Population)
time frame: At Month 12 of Study Medication Dosing
description: The subject's rating was documented on a four-point scale from no pain (= 0), mild pain (= 1), moderate pain (= 2) to severe pain (= 3). Pain freedom means the pain went from moderate (2) or severe (3) to no pain (0).
measure: Percentage of Participants With Attacks With Sustained Freedom From Most Bothersome Symptom 2-48 Hours (Modified Intent to Treat Population)
time frame: At Month 12 of Study Drug Administration
description: Subjects were prompted to document the presence of 3 symptoms (photophobia, phonophobia, and nausea) immediately before study drug administration and during the treated migraine attack.
arm group label: STS101
arm group type: Experimental
description: STS101 (dihydroergotamine nasal powder)
intervention type: Drug
intervention name: Dihydroergotamine
description: Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
arm group label: STS101
other name: Dihydroergotamine Mesylate
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Detlef Albrecht, MD
role: Study Chair
affiliation: Satsuma Pharmaceuticals, Inc.
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country: United States
responsible party type: Sponsor
mesh term: Migraine Disorders
mesh term: Migraine without Aura
mesh term: Migraine with Aura
mesh term: Dihydroergotamine
sharing ipd: No
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