<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/NCT03260920</url>
  </required_header>
  <id_info>
    <org_study_id>FTDOXY17EF</org_study_id>
    <nct_id>NCT03260920</nct_id>
  </id_info>
  <brief_title>Intranasal Oxytocin for Frontotemporal Dementia</brief_title>
  <acronym>FOXY</acronym>
  <official_title>A Phase 2 Clinical Trial of Intranasal Oxytocin for Frontotemporal Dementia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Weston Brain Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Berry Consultants</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of this study is to assess the safety, tolerability and effects on behaviour of&#xD;
      Syntocinon given intranasally (by a spray into the nostrils) compared to placebo (an inactive&#xD;
      saline substance that contains no medication) in participants with frontotemporal&#xD;
      dementia/Pick's disease. This study will take place in approximately 15 centres across Canada&#xD;
      and the United States. Approximately 112 patients in total will be enrolled in this study. In&#xD;
      the first phase we will examine which of three different dosing schedules of oxytocin may be&#xD;
      more effective. In the second phase of the study, patients entering the study will be&#xD;
      randomized to the oxytocin dosing schedule that appeared most effective in the first phase.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 31, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>A Proof-of-Concept Double Blind Randomized Controlled, Cross-Over Adaptive Design Trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double Blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Neuropsychiatric Inventory (NPI) apathy/indifference domain score</measure>
    <time_frame>Up to 20 weeks</time_frame>
    <description>Pilot data from our two prior studies of oxytocin in FTD have driven the selection of the NPI as the primary outcome measure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in emotional facial expression recognition performance</measure>
    <time_frame>Up to 20 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Revised Self-Monitoring Scale score</measure>
    <time_frame>Up to 20 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in modified Clinicians Global Impression of Change (apathy) scores</measure>
    <time_frame>Up to 20 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">112</enrollment>
  <condition>Frontotemporal Dementia</condition>
  <arm_group>
    <arm_group_label>Low Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Medium Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>High Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Syntocinon</intervention_name>
    <description>Intranasal Oxytocin</description>
    <arm_group_label>High Dose</arm_group_label>
    <arm_group_label>Low Dose</arm_group_label>
    <arm_group_label>Medium Dose</arm_group_label>
    <other_name>Intranasal Oxytocin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of probable FTD (behavioural variant FTD, FTD-semantic subtype or&#xD;
             FTD-Progressive Nonfluent Aphasia) with supportive brain imaging (centrally rated&#xD;
             frontotemporal atrophy score of 2 or greater on brain MRI or CT) or known FTD causing&#xD;
             genetic mutation.68&#xD;
&#xD;
          -  Current symptoms of social apathy/indifference as measured by NPI apathy/indifference&#xD;
             severity subscale score &gt;= 2 indicating the presence of moderate to marked levels of&#xD;
             apathy/indifference.&#xD;
&#xD;
          -  Study partner who consents to study participation and who cares for/visits the patient&#xD;
             daily for at least 3 hours/day and who can administer all trial medications.&#xD;
&#xD;
          -  FTLD-CDR score 0-2.&#xD;
&#xD;
          -  MMSE &gt;10.&#xD;
&#xD;
          -  Stable baseline medications related to cognition or behaviour for &gt;=30 days such as&#xD;
             acetylcholinesterase inhibitors, memantine, anti-depressants, antipsychotic agents,&#xD;
             other mood stabilizers, benzodiazepines.&#xD;
&#xD;
          -  Written informed consent must be obtained and documented (from the patient or, where&#xD;
             jurisdictions allow it, from their substitute decision maker).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of stroke, other neurologic or psychiatric disorder other than FTD that is&#xD;
             considered to better account for behavioural symptoms.&#xD;
&#xD;
          -  History of a myocardial infarction within the last two years or congestive heart&#xD;
             failure.&#xD;
&#xD;
          -  Current uncontrolled hypertension&#xD;
&#xD;
          -  Current bradycardia (rate &lt; 50 beats per minute/bpm) or tachycardia (rate &gt; 100 bpm)&#xD;
&#xD;
          -  Current hyponatremia (Na &lt;135 mEq/L)&#xD;
&#xD;
          -  Current use of topical prostaglandin medications applied to the cervix.&#xD;
&#xD;
          -  Females who are pregnant or breastfeeding, or planning to conceive within the study&#xD;
             period.&#xD;
&#xD;
          -  Use of any investigational or experimental drug or device within the last 60 days&#xD;
             prior to screening or within 5 half-lives of the experimental drug, whichever is&#xD;
             longer.&#xD;
&#xD;
          -  Participant has speech difficulties that in the opinion of the investigator would be&#xD;
             incompatible with neuropsychology and safety assessments&#xD;
&#xD;
          -  History of cancer except:&#xD;
&#xD;
               -  If considered to be cured&#xD;
&#xD;
               -  If not being actively treated with anti-cancer therapy or radiotherapy and, in&#xD;
                  the opinion of the investigator, not likely to require treatment in the ensuing 5&#xD;
                  years&#xD;
&#xD;
               -  For prostate cancer or basal cell carcinoma, no significant progression over the&#xD;
                  previous 2 years&#xD;
&#xD;
          -  Any clinically significant hematological, endocrine, cardiovascular, renal, hepatic,&#xD;
             gastrointestinal or neurological disease. If the condition has been stable for at&#xD;
             least the past year and is judged by the investigator not to interfere with the&#xD;
             patient's participation in the study, the patient may be included.&#xD;
&#xD;
          -  For the CSF sub-study, current use of anticoagulant medications (warfarin,&#xD;
             rivaroxaban, etc.).&#xD;
&#xD;
          -  Plan for FTD patient to be placed into long-term care or plan for hospital admission&#xD;
             for any kind of treatment within study period or if caregiver plans for&#xD;
             holidays/respite care &gt; 3 days during study period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UCLA</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins Bayview Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of British Columbia</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkwood Institute</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6C 0A7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Health Network</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montreal Neurological Institute and Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laval University</name>
      <address>
        <city>Quebec</city>
        <zip>G1J1Z4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 19, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>March 16, 2023</last_update_submitted>
  <last_update_submitted_qc>March 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>oxytocin</keyword>
  <keyword>frontotemporal dementia</keyword>
  <keyword>apathy</keyword>
  <keyword>empathy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Frontotemporal Dementia</mesh_term>
    <mesh_term>Aphasia, Primary Progressive</mesh_term>
    <mesh_term>Pick Disease of the Brain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxytocin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03260920
org study id: FTDOXY17EF
nct id: NCT03260920
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to assess the safety, tolerability and effects on behaviour of
      Syntocinon given intranasally (by a spray into the nostrils) compared to placebo (an inactive
      saline substance that contains no medication) in participants with frontotemporal
      dementia/Pick's disease. This study will take place in approximately 15 centres across Canada
      and the United States. Approximately 112 patients in total will be enrolled in this study. In
      the first phase we will examine which of three different dosing schedules of oxytocin may be
      more effective. In the second phase of the study, patients entering the study will be
      randomized to the oxytocin dosing schedule that appeared most effective in the first phase.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: A Proof-of-Concept Double Blind Randomized Controlled, Cross-Over Adaptive Design Trial
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double Blind
measure: Change in Neuropsychiatric Inventory (NPI) apathy/indifference domain score
time frame: Up to 20 weeks
description: Pilot data from our two prior studies of oxytocin in FTD have driven the selection of the NPI as the primary outcome measure.
measure: Change in emotional facial expression recognition performance
time frame: Up to 20 weeks
measure: Change in the Revised Self-Monitoring Scale score
time frame: Up to 20 weeks
measure: Change in modified Clinicians Global Impression of Change (apathy) scores
time frame: Up to 20 weeks
arm group label: Low Dose
arm group type: Experimental
arm group label: Medium Dose
arm group type: Experimental
arm group label: High Dose
arm group type: Experimental
intervention type: Drug
intervention name: Syntocinon
description: Intranasal Oxytocin
arm group label: High Dose
arm group label: Low Dose
arm group label: Medium Dose
other name: Intranasal Oxytocin
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Dementia
mesh term: Frontotemporal Dementia
mesh term: Aphasia, Primary Progressive
mesh term: Pick Disease of the Brain
mesh term: Oxytocin
sharing ipd: No