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/NCT06004388</url>
    </required_header>
    <id_info>
      <org_study_id>CT-132-R-002</org_study_id>
      <nct_id>NCT06004388</nct_id>
    </id_info>
    <brief_title>Study of Two Digital Therapeutics for the Prevention of Episodic Migraine Receiving CGRP Therapy (ReMMiD-C)</brief_title>
    <official_title>A Randomized, Double-Blind, Parallel-Group, Virtual Study to Evaluate the Efficacy and Safety of Two Prescription Digital Therapeutics for the Prevention of Episodic Migraine in Late Adolescents and Adults Currently Receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Click Therapeutics, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Click Therapeutics, Inc.</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Randomized study of two digital therapeutics for the prevention of episodic migraine in&#xD;
        patients currently receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this randomized trial is to evaluate the efficacy and safety of two&#xD;
        prescription mobile applications that provide an interactive, software-based intervention for&#xD;
        the preventative treatment of episodic migraine in late adolescents and adults who are&#xD;
        receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 21, 2023</start_date>
    <completion_date type="Anticipated">February 21, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 21, 2024</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>Double-blind</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Monthly Migraine Days (MMDs)</measure>
      <time_frame>Baseline to Week 12</time_frame>
      <description>Change from baseline in the number of Monthly Migraine Days (MMDs) at Week 12</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Proportion of Patients with Decrease in MMDs</measure>
      <time_frame>Baseline to Week 12</time_frame>
      <description>Proportion of participants who have at least a 50% reduction from baseline in the mean number of MMDs at Week 12</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in MMDs at Weeks 4 and 8</measure>
      <time_frame>Baseline to Weeks 4 and 8</time_frame>
      <description>Change from baseline in the number of MMDs recorded over the previous 28 days at Week 4 and Week 8</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Mean MMDs</measure>
      <time_frame>Baseline to Week 12</time_frame>
      <description>Reduction from baseline in the mean number of MMDs over 12 weeks</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Average Headache Severity</measure>
      <time_frame>Run-in to Weeks 9-12</time_frame>
      <description>Change in the average severity of headache from the run-in period to Weeks 9-12</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Migraine Questionnaire</measure>
      <time_frame>Baseline to Weeks 4, 8 and 12</time_frame>
      <description>Change from baseline in the Migraine-Specific Quality-of-Life Questionnaire v2.1 (MSQ) at Week 4, Week 8, and Week 12</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Migraine Disability Assessment (MIDAS)</measure>
      <time_frame>Baseline to Weeks 4, 8, and 12</time_frame>
      <description>Change from baseline in the Migraine Disability Assessment (MIDAS) at Week 4, Week 8, and Week 12</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Migraine Medication Use (frequency)</measure>
      <time_frame>Run-in to Weeks 9-12</time_frame>
      <description>Change in the use (frequency) of acute migraine medications from the run-in period to Weeks 9-12</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Migraine Medication Use (dose)</measure>
      <time_frame>Run-in to Weeks 9-12</time_frame>
      <description>Change in the use (dose) of acute migraine medications from the run-in period to Weeks 9-12</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Migraine Medication Use (medication type)</measure>
      <time_frame>Run-in to Weeks 9-12</time_frame>
      <description>Change in the use (type) of acute migraine medications from the run-in period to Weeks 9-12</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Migraine</condition>
    <condition>Episodic Migraine</condition>
    <condition>Headache</condition>
    <condition>Headache, Migraine</condition>
    <arm_group>
      <arm_group_label>ReMMiD-C Therapeutic Arm A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Mobile application A (ReMMiD-C Digital Therapeutic) as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>ReMMiD-C Therapeutic Arm B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Mobile application B as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Click Digital Therapeutic</intervention_name>
      <description>Evaluate the efficacy and safety of prescription mobile applications that provide an interactive, software-based intervention for the preventative treatment of episodic migraine in late adults and adolescents receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy</description>
      <arm_group_label>ReMMiD-C Therapeutic Arm A</arm_group_label>
      <arm_group_label>ReMMiD-C Therapeutic Arm B</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  A participant will be eligible for entry into the study if all of the following&#xD;
               criteria are met per participant self-report:&#xD;
  &#xD;
            -  Willing and able to provide written informed consent to participate in the study,&#xD;
               attend study visits, and comply with study-related requirements and assessments.&#xD;
  &#xD;
            -  Lives in the United States.&#xD;
  &#xD;
            -  Adult or late adolescent, ≥ 18 years of age at the time of informed consent.&#xD;
  &#xD;
            -  Able to read and understand the English informed consent form.&#xD;
  &#xD;
            -  The following will be investigator-reviewed: Participant has at least a 1-year history&#xD;
               of migraine (with or without aura) consistent with a diagnosis according to the&#xD;
               International Classification of Headache Disorders (ICHD), 3rd Edition:&#xD;
  &#xD;
               i. Age of onset of migraines prior to 50 years of age&#xD;
  &#xD;
          ii. Migraine attacks, on average, lasting 4-72 hours if untreated&#xD;
  &#xD;
          iii. Per participant report, 4 or more migraine days per month within the last 3 months&#xD;
          prior to the Screening Visit (a month is defined as 28 days)&#xD;
  &#xD;
          iv. Four to fourteen migraine days during the run-in period&#xD;
  &#xD;
            -  Is currently managing migraines with at least 1 prescription CGRP inhibitor therapy&#xD;
               for the preventive or acute treatment of episodic or chronic migraine during the 3&#xD;
               months prior to screening.&#xD;
  &#xD;
            -  Is the sole user of an iPhone with an iPhone operating system (iOS) 14 or later or a&#xD;
               smartphone with an Android operating system (OS) 11 or later, and is willing to&#xD;
               download and use the specified eDiary and Study App required by the protocol.&#xD;
  &#xD;
            -  Is willing and able to receive SMS text messages and push messages on their&#xD;
               smartphone.&#xD;
  &#xD;
            -  Is the owner of, and has regular access to, an email address.&#xD;
  &#xD;
            -  Has regular access to the Internet via cellular data plan and/or wifi.&#xD;
  &#xD;
            -  Understands the use of and interest in the eDiary and the Study App during the&#xD;
               screening period and the baseline visit (Day 1).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  A participant will not be eligible for study entry if any of the following criteria&#xD;
               are met per participant self-report:&#xD;
  &#xD;
            -  History of basilar migraine or hemiplegic migraine.&#xD;
  &#xD;
            -  Active chronic pain syndromes, such as fibromyalgia, chronic pelvic pain, or complex&#xD;
               regional pain syndrome (CRPS).&#xD;
  &#xD;
            -  Other pain syndromes (including trigeminal neuralgia), psychiatric conditions (such as&#xD;
               current major depressive episode, bipolar disorder, major depressive disorder,&#xD;
               schizophrenia), dementia, or significant neurological disorders (other than migraine)&#xD;
               that, in the Investigator's opinion, might interfere with study assessments.&#xD;
  &#xD;
            -  History of, treatment for, or evidence of, alcohol or drug abuse within the past 12&#xD;
               months (48 weeks) or having met DSM-5 criteria for any significant substance use&#xD;
               disorder within the past 12 months (48 weeks) from the date of the screening visit.&#xD;
  &#xD;
            -  History of use of analgesics (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs] or&#xD;
               acetaminophen, including opioids) or butalbital on ≥ 15 days per month during the 3&#xD;
               months (12 weeks) prior to the Screening Visit or during the run-in period.&#xD;
  &#xD;
            -  Post-traumatic headache, persistent post-traumatic headache, or post-concussion&#xD;
               syndrome.&#xD;
  &#xD;
            -  Other significant acute or chronic medical condition(s) that, in the opinion of the&#xD;
               Investigator, may confound the interpretation of findings to inform PDT development.&#xD;
  &#xD;
            -  Failure to adhere with or inability to complete eDiary inputs and onboarding&#xD;
               activities during the run-in period. Participants who are not adherent during the&#xD;
               run-in period are not eligible for study entry.&#xD;
  &#xD;
            -  Previous enrollment in any digital therapeutics pilot or pivotal study for a migraine&#xD;
               indication.&#xD;
  &#xD;
            -  Participation in any other investigational clinical study&#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>Shaheen Lakhan</last_name>
      <role>Study Director</role>
      <affiliation>Click Therapeutics</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Research Coordinator</last_name>
      <phone>877-352-5425</phone>
      <email>researchcoordinator@clicktherapeutics.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Click Therapeutics</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10013</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Research Coordinator</last_name>
        <phone>877-352-5425</phone>
        <email>researchcoordinator@clicktherapeutics.com</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Prescription digital therapeutic (PDT)</keyword>
    <keyword>Software as a Medical Device (SaMD)</keyword>
    <keyword>Smartphone app</keyword>
    <keyword>CGRP</keyword>
    <keyword>Calcitonin Gene-Related Peptide Inhibitor Therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Migraine Disorders</mesh_term>
      <mesh_term>Headache</mesh_term>
    </condition_browse>
    <!-- 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/NCT06004388
  org study id: CT-132-R-002
  nct id: NCT06004388
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: No
  Randomized study of two digital therapeutics for the prevention of episodic migraine in
        patients currently receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy
  The purpose of this randomized trial is to evaluate the efficacy and safety of two
        prescription mobile applications that provide an interactive, software-based intervention for
        the preventative treatment of episodic migraine in late adolescents and adults who are
        receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  masking description: Double-blind
  measure: Change in Monthly Migraine Days (MMDs)
  time frame: Baseline to Week 12
  description: Change from baseline in the number of Monthly Migraine Days (MMDs) at Week 12
  measure: Proportion of Patients with Decrease in MMDs
  time frame: Baseline to Week 12
  description: Proportion of participants who have at least a 50% reduction from baseline in the mean number of MMDs at Week 12
  measure: Change in MMDs at Weeks 4 and 8
  time frame: Baseline to Weeks 4 and 8
  description: Change from baseline in the number of MMDs recorded over the previous 28 days at Week 4 and Week 8
  measure: Change in Mean MMDs
  time frame: Baseline to Week 12
  description: Reduction from baseline in the mean number of MMDs over 12 weeks
  measure: Change in Average Headache Severity
  time frame: Run-in to Weeks 9-12
  description: Change in the average severity of headache from the run-in period to Weeks 9-12
  measure: Change in Migraine Questionnaire
  time frame: Baseline to Weeks 4, 8 and 12
  description: Change from baseline in the Migraine-Specific Quality-of-Life Questionnaire v2.1 (MSQ) at Week 4, Week 8, and Week 12
  measure: Change in Migraine Disability Assessment (MIDAS)
  time frame: Baseline to Weeks 4, 8, and 12
  description: Change from baseline in the Migraine Disability Assessment (MIDAS) at Week 4, Week 8, and Week 12
  measure: Change in Migraine Medication Use (frequency)
  time frame: Run-in to Weeks 9-12
  description: Change in the use (frequency) of acute migraine medications from the run-in period to Weeks 9-12
  measure: Change in Migraine Medication Use (dose)
  time frame: Run-in to Weeks 9-12
  description: Change in the use (dose) of acute migraine medications from the run-in period to Weeks 9-12
  measure: Change in Migraine Medication Use (medication type)
  time frame: Run-in to Weeks 9-12
  description: Change in the use (type) of acute migraine medications from the run-in period to Weeks 9-12
  arm group label: ReMMiD-C Therapeutic Arm A
  arm group type: Experimental
  description: Mobile application A (ReMMiD-C Digital Therapeutic) as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy.
  arm group label: ReMMiD-C Therapeutic Arm B
  arm group type: Experimental
  description: Mobile application B as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy.
  intervention type: Device
  intervention name: Click Digital Therapeutic
  description: Evaluate the efficacy and safety of prescription mobile applications that provide an interactive, software-based intervention for the preventative treatment of episodic migraine in late adults and adolescents receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy
  arm group label: ReMMiD-C Therapeutic Arm A
  arm group label: ReMMiD-C Therapeutic Arm B
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Shaheen Lakhan
  role: Study Director
  affiliation: Click Therapeutics
  last name: Research Coordinator
  phone: 877-352-5425
  email: researchcoordinator@clicktherapeutics.com
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Migraine Disorders
  mesh term: Headache