xml: <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/NCT05989048</url>
    </required_header>
    <id_info>
      <org_study_id>C5301008</org_study_id>
      <nct_id>NCT05989048</nct_id>
    </id_info>
    <brief_title>A Study to Learn About Zavegepant as the Acute Treatment of Migraine in Asian Adults</brief_title>
    <official_title>A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Zavegepant Intranasal (IN) for the Acute Treatment of Migraine in Asian Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Pfizer</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Pfizer</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to learn how safe and effective zavegepant is compared to&#xD;
        placebo in the acute treatment of migraine in Asian adults. Migraine is a very painful&#xD;
        headache with other associated symptoms such as nausea, photophobia and phonophobia. A&#xD;
        placebo is a harmless treatment that has no medical effect.&#xD;
  &#xD;
        This study is seeking for participants who:&#xD;
  &#xD;
          -  have at least 1 year of migraine history before entering the study.&#xD;
  &#xD;
          -  have 2 to 8 migraine headache attacks of moderate or severe intensity in each of the 3&#xD;
             months before entering the study.&#xD;
  &#xD;
          -  have less than 15 days with headaches in each of the 3 months before entering the study.&#xD;
             The headaches could be either due to migraine or not.&#xD;
  &#xD;
        The participants in this study will receive zavegepant or placebo through intranasal route.&#xD;
        Intranasal means medicine which is given through nose. Zavegepant or placebo will be taken if&#xD;
        the participants have a migraine headache of moderate or severe intensity.&#xD;
  &#xD;
        The study will compare the experiences of people receiving zavegepant to those of the people&#xD;
        receiving placebo. This will help see if zavegepant is safe and effective in Asian adults.&#xD;
  &#xD;
        Participants will be in this study for up to about 16 weeks. Participants will have 3 study&#xD;
        visits at the study clinic and 1 through telephone contact.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 10, 2023</start_date>
    <completion_date type="Anticipated">September 5, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2025</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Parallel Assignment</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage of participants with pain freedom at 2 hours post dose.</measure>
      <time_frame>2 hours post dose</time_frame>
      <description>To compare the efficacy of zavegepant with placebo in the acute treatment of migraine by measuring freedom from pain.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of participants with an MBS (most bothersome symptom) reported before dosing that is absent at 2 hours post dose.</measure>
      <time_frame>2 hours post dose</time_frame>
      <description>To compare the efficacy of zavegepant with placebo in the acute treatment of migraine by measuring freedom from MBS.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">1400</enrollment>
    <condition>Migraine</condition>
    <arm_group>
      <arm_group_label>Zavegepant</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Zavegepant intranasal 10 mg</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Zavegepant</intervention_name>
      <description>The participants will receive single active dose sufficient to treat 1 migraine headache of moderate or severe intensity within Treatment Phase.</description>
      <arm_group_label>Zavegepant</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Single dose of matching placebo taken within Treatment Phase.</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Asian participants aged 18 years or older at screening.&#xD;
  &#xD;
            -  Participants with minimum 1 year history of migraine (with or without aura) prior to&#xD;
               the Screening Visit, consistent with a diagnosis according to the International&#xD;
               Classification of Headache Disorders, 3rd Edition, including the following:&#xD;
  &#xD;
                 1. Migraine attacks present for more than 1 year with the age of onset prior to 50&#xD;
                    years of age.&#xD;
  &#xD;
                 2. Migraine attacks, on average, lasting about 4-72 hours if untreated.&#xD;
  &#xD;
                 3. Not more than 8 attacks of moderate or severe pain intensity per month within&#xD;
                    last 3 months.&#xD;
  &#xD;
                 4. Participants must be able to distinguish migraine attacks from tension/cluster&#xD;
                    headaches.&#xD;
  &#xD;
                 5. At least 2 consistent migraine headache attacks of moderate or severe intensity&#xD;
                    in each of the 3 months prior to the Screening Visit and throughout the Screening&#xD;
                    Phase (participant self-report).&#xD;
  &#xD;
                 6. Less than 15 days with headaches (migraine or non-migraine) per month in each of&#xD;
                    the 3 months prior to the Screening Visit and throughout the Screening Phase&#xD;
                    (participant self-report).&#xD;
  &#xD;
                 7. Participants on prophylactic migraine medication are permitted to remain on&#xD;
                    therapy if they have been on a stable dose for at least 3 months prior to&#xD;
                    Screening Visit, and if the dose is not expected to change through the End of&#xD;
                    Treatment Visit.&#xD;
  &#xD;
                 8. Participants with contraindications for use of triptans may be included provided&#xD;
                    they meet all other study entry criteria.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of retinal migraine, basilar migraine or hemiplegic migraine.&#xD;
  &#xD;
            -  History or current evidence of uncontrolled, unstable or recently diagnosed&#xD;
               cardiovascular or cardiometabolic disease.&#xD;
  &#xD;
            -  Major depressive disorder, anxiety disorder, or other significant psychiatric&#xD;
               disorder.&#xD;
  &#xD;
            -  Acute or chronic pain syndromes, psychiatric conditions, dementia, or significant&#xD;
               neurological disorders (other than migraine) that interfere with study assessments.&#xD;
  &#xD;
            -  Conditions that may affect the administration or absorption of the nasal product.&#xD;
  &#xD;
            -  Medication overuse headaches.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Pfizer CT.gov Call Center</last_name>
      <role>Study Director</role>
      <affiliation>Pfizer</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Pfizer CT.gov Call Center</last_name>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Chinese PLA General Hospital</name>
        <address>
          <city>Haidian District</city>
          <state>Beijing</state>
          <zip>100853</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <link>
      <url>https://pmiform.com/clinical-trial-info-request?StudyID=C5301008</url>
      <description>To obtain contact information for a study center near you, click here.</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</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>Migraine Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
      <ipd_url>https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05989048
  org study id: C5301008
  nct id: NCT05989048
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  The purpose of this study is to learn how safe and effective zavegepant is compared to
        placebo in the acute treatment of migraine in Asian adults. Migraine is a very painful
        headache with other associated symptoms such as nausea, photophobia and phonophobia. A
        placebo is a harmless treatment that has no medical effect.
  
        This study is seeking for participants who:
  
          -  have at least 1 year of migraine history before entering the study.
  
          -  have 2 to 8 migraine headache attacks of moderate or severe intensity in each of the 3
             months before entering the study.
  
          -  have less than 15 days with headaches in each of the 3 months before entering the study.
             The headaches could be either due to migraine or not.
  
        The participants in this study will receive zavegepant or placebo through intranasal route.
        Intranasal means medicine which is given through nose. Zavegepant or placebo will be taken if
        the participants have a migraine headache of moderate or severe intensity.
  
        The study will compare the experiences of people receiving zavegepant to those of the people
        receiving placebo. This will help see if zavegepant is safe and effective in Asian adults.
  
        Participants will be in this study for up to about 16 weeks. Participants will have 3 study
        visits at the study clinic and 1 through telephone contact.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Percentage of participants with pain freedom at 2 hours post dose.
  time frame: 2 hours post dose
  description: To compare the efficacy of zavegepant with placebo in the acute treatment of migraine by measuring freedom from pain.
  measure: Percentage of participants with an MBS (most bothersome symptom) reported before dosing that is absent at 2 hours post dose.
  time frame: 2 hours post dose
  description: To compare the efficacy of zavegepant with placebo in the acute treatment of migraine by measuring freedom from MBS.
  arm group label: Zavegepant
  arm group type: Experimental
  description: Zavegepant intranasal 10 mg
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Placebo
  intervention type: Drug
  intervention name: Zavegepant
  description: The participants will receive single active dose sufficient to treat 1 migraine headache of moderate or severe intensity within Treatment Phase.
  arm group label: Zavegepant
  intervention type: Drug
  intervention name: Placebo
  description: Single dose of matching placebo taken within Treatment Phase.
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Pfizer CT.gov Call Center
  role: Study Director
  affiliation: Pfizer
  last name: Pfizer CT.gov Call Center
  phone: 1-800-718-1021
  email: ClinicalTrials.gov_Inquiries@pfizer.com
  facility: 
  country: China
  url: https://pmiform.com/clinical-trial-info-request?StudyID=C5301008
  description: To obtain contact information for a study center near you, click here.
  responsible party type: Sponsor
  mesh term: Migraine Disorders
  sharing ipd: Yes
  ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
  ipd url: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests