<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/NCT04470752</url>
  </required_header>
  <id_info>
    <org_study_id>BASEC 2020-01362</org_study_id>
    <secondary_id>08.011</secondary_id>
    <nct_id>NCT04470752</nct_id>
  </id_info>
  <brief_title>Capsaicin for Post-stroke Dysphagia</brief_title>
  <acronym>CADYS</acronym>
  <official_title>Capsaicin for Post-stroke Dysphagia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Georg Kägi, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cantonal Hospital of Aarau, Switzerland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cantonal Hospital of St. Gallen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomised, double blind, Phase 2 Trial to evaluate the efficacy of oral Capsaicin in&#xD;
      patients with post-stroke dysphagia in the (sub-)acute setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After inclusion and the assessment of the swallowing function (PRESS, PAS, FOIS, FEES)&#xD;
      patients will be randomised 1:1 to receive 1mcg Capsaicin or Placebo. Oral treatment will be&#xD;
      applied 3 times daily either during meals or during regular swallowing tests/trainings&#xD;
      accompanied by a Speech Language Pathologist. After re-assessment of the dysphagia after 7&#xD;
      days, patients with persistent dysphagia and applicable for further treatment will be treated&#xD;
      for another 23 days with a final clinical swallowing evaluation after a total of 30 days. A&#xD;
      Patient Medication Diary will used during the Duration of the Trial to capture compliance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 24, 2021</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2024</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Both study drug and Placebo have identical packaging (brown glass bottle) and labeling (Capsaicin or Placebo). Both use the same liquid suspension, same colour, and consistency..</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Penetration Aspiration Scale (PAS) score</measure>
    <time_frame>7 days after randomisation</time_frame>
    <description>the between-group difference of the Penetration Aspiration Scale (PAS) assessed with functional endoscopic evaluation of swallowing (FEES) 7 days after admission.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional Oral Intake Scale (FOIS) score</measure>
    <time_frame>at day 7 and 30 post admission</time_frame>
    <description>Between group differences (capsaicin / placebo) of Functional Oral Intake Scale (FOIS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>days of nasogastric tube feeding</measure>
    <time_frame>from randomisation until day 30</time_frame>
    <description>Between group differences (capsaicin / placebo) of days of nasogastric tube feedings</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of patients with Percutaneous endoscopic gastrostomy (PEG) tube placement</measure>
    <time_frame>from randomisation until day 30</time_frame>
    <description>Between group differences (capsaicin / Placebo) of number of patients with PEG tube placement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of patients with aspiration pneumonia</measure>
    <time_frame>from randomisation until day 30</time_frame>
    <description>Between group differences (capsaicin / Placebo) of number of patients with aspiration pneumonia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Swallowing quality of life questionnaire (Swal-QoL) score</measure>
    <time_frame>from randomisation until day 30</time_frame>
    <description>Between group differences (capsaicin / Placebo) of Swallowing quality of life questionnaire (Swal-QoL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Latency of the Swallowing reflex</measure>
    <time_frame>from randomisation until day 30</time_frame>
    <description>Between group differences (capsaicin / Placebo) of Latency of the Swallowing reflex</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>modified Ranking Scale (mRS) score</measure>
    <time_frame>from randomisation until day 30</time_frame>
    <description>Between group differences (capsaicin / Placebo) of modified Ranking Scale (mRS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Penetration Aspiration Scale (PAS) and/or Functional Oral Intake Score (FOIS) with supratentorial stroke</measure>
    <time_frame>after 7 and 30 days post admission</time_frame>
    <description>admission of patients with and without sensory deficits (only supratentorial strokes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Penetration Aspiration Scale (PAS) and/or Functional Oral Intake with supra-infratentorial stroke</measure>
    <time_frame>after 7 and 30 days post admission</time_frame>
    <description>of patients with stroke localisation with respect to supra-infratentorial localisation and involvement of sensory/motor swallowing cortex with its connections</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events (safety and tolerability)</measure>
    <time_frame>30 days post admission</time_frame>
    <description>Potential harm will be assessed by comparing between-group differences (verum/placebo) of hypothermia and other (serious) adverse events which are not known yet, but will be collected systemically during this trial.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">82</enrollment>
  <condition>Dysphagia, Late Effect of Stroke</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>InOrpha solution/ml, three times daily with meals for the Treatment period, 7 or 30 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Capsaicin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>InOrpha solution plus 1 mcg Capsaicin/ml, three times daily with meals for the Treatment period of 7 or 30 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capsaicin 1% oral solution</intervention_name>
    <description>Capsaicin 1.0 micrograms/ml</description>
    <arm_group_label>Capsaicin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>InOrpha Solution</intervention_name>
    <description>glycerol based suspension vehicle</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute ischemic Stroke&#xD;
&#xD;
          -  Impairment of oral intake with FOIS ≤ 4&#xD;
&#xD;
          -  Magnetic Resonance Imaging of the brain or CT scan with the finding of a subacute&#xD;
             ischemic stroke&#xD;
&#xD;
          -  Informed Consent within 48 hours after admission, following initial swallowing&#xD;
             assessment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis other than ischemic stroke&#xD;
&#xD;
          -  Late patient admission &gt;48 hours after stroke onset&#xD;
&#xD;
          -  Impairment of functional oral intake scale ≥ 5&#xD;
&#xD;
          -  FEES &gt;72h after admission&#xD;
&#xD;
          -  PAS &lt;2&#xD;
&#xD;
          -  Pre-existing dysphagia&#xD;
&#xD;
          -  Dysphagia due to other cause&#xD;
&#xD;
          -  No evidence of stroke on imaging&#xD;
&#xD;
          -  Recurrent stroke = at least one stroke in the course of the study apart from the index&#xD;
             stroke&#xD;
&#xD;
          -  Age &lt;18 years&#xD;
&#xD;
          -  Current drug abuse&#xD;
&#xD;
          -  Amphetamine or amphetamine-like Medication&#xD;
&#xD;
          -  Regular oral treatment with chilli pepper extract&#xD;
&#xD;
          -  Allergies or known adverse reactions to the consumption of chilli pepper or capsaicin&#xD;
&#xD;
          -  Personality disorder&#xD;
&#xD;
          -  Severe dementia or delirium&#xD;
&#xD;
          -  Other reasons according to physician/investigator because of which the patient cannot&#xD;
             participate in the study (not suitable for treatment or examinations)&#xD;
&#xD;
          -  withdrawal of consent by participant at any time of the 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>Georg kägi, Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cantonal Hospital St. Gallen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Georg Kägi, Dr.med.</last_name>
    <phone>+41 71 494 3594</phone>
    <email>georg.kaegi@kssg.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anna Müller, RN</last_name>
    <phone>+41 71 494 2958</phone>
    <email>anna.mueller2@kssg.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kantonsspital St. Gallen</name>
      <address>
        <city>St. Gallen</city>
        <state>Saint Gallen</state>
        <zip>9007</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <link>
    <url>https://play.google.com/store/apps/details?id=ch.kssg.press&amp;hl=en_US</url>
    <description>PRESS App</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>June 19, 2023</last_update_submitted>
  <last_update_submitted_qc>June 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cantonal Hospital of St. Gallen</investigator_affiliation>
    <investigator_full_name>Georg Kägi, MD</investigator_full_name>
    <investigator_title>Senior Physician and Head of the Stroke Center</investigator_title>
  </responsible_party>
  <keyword>Dysphagia</keyword>
  <keyword>Stroke</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deglutition Disorders</mesh_term>
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Capsaicin</mesh_term>
    <mesh_term>Pharmaceutical Solutions</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>We plan to upload the study protocol after trial completion</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>after Trial completion indefinitely</ipd_time_frame>
  </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/NCT04470752
org study id: BASEC 2020-01362
secondary id: 08.011
nct id: NCT04470752
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Randomised, double blind, Phase 2 Trial to evaluate the efficacy of oral Capsaicin in
      patients with post-stroke dysphagia in the (sub-)acute setting.
After inclusion and the assessment of the swallowing function (PRESS, PAS, FOIS, FEES)
      patients will be randomised 1:1 to receive 1mcg Capsaicin or Placebo. Oral treatment will be
      applied 3 times daily either during meals or during regular swallowing tests/trainings
      accompanied by a Speech Language Pathologist. After re-assessment of the dysphagia after 7
      days, patients with persistent dysphagia and applicable for further treatment will be treated
      for another 23 days with a final clinical swallowing evaluation after a total of 30 days. A
      Patient Medication Diary will used during the Duration of the Trial to capture compliance.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Both study drug and Placebo have identical packaging (brown glass bottle) and labeling (Capsaicin or Placebo). Both use the same liquid suspension, same colour, and consistency..
measure: Penetration Aspiration Scale (PAS) score
time frame: 7 days after randomisation
description: the between-group difference of the Penetration Aspiration Scale (PAS) assessed with functional endoscopic evaluation of swallowing (FEES) 7 days after admission.
measure: Functional Oral Intake Scale (FOIS) score
time frame: at day 7 and 30 post admission
description: Between group differences (capsaicin / placebo) of Functional Oral Intake Scale (FOIS)
measure: days of nasogastric tube feeding
time frame: from randomisation until day 30
description: Between group differences (capsaicin / placebo) of days of nasogastric tube feedings
measure: number of patients with Percutaneous endoscopic gastrostomy (PEG) tube placement
time frame: from randomisation until day 30
description: Between group differences (capsaicin / Placebo) of number of patients with PEG tube placement
measure: number of patients with aspiration pneumonia
time frame: from randomisation until day 30
description: Between group differences (capsaicin / Placebo) of number of patients with aspiration pneumonia
measure: Swallowing quality of life questionnaire (Swal-QoL) score
time frame: from randomisation until day 30
description: Between group differences (capsaicin / Placebo) of Swallowing quality of life questionnaire (Swal-QoL)
measure: Latency of the Swallowing reflex
time frame: from randomisation until day 30
description: Between group differences (capsaicin / Placebo) of Latency of the Swallowing reflex
measure: modified Ranking Scale (mRS) score
time frame: from randomisation until day 30
description: Between group differences (capsaicin / Placebo) of modified Ranking Scale (mRS)
measure: Change of Penetration Aspiration Scale (PAS) and/or Functional Oral Intake Score (FOIS) with supratentorial stroke
time frame: after 7 and 30 days post admission
description: admission of patients with and without sensory deficits (only supratentorial strokes)
measure: Change of Penetration Aspiration Scale (PAS) and/or Functional Oral Intake with supra-infratentorial stroke
time frame: after 7 and 30 days post admission
description: of patients with stroke localisation with respect to supra-infratentorial localisation and involvement of sensory/motor swallowing cortex with its connections
measure: Incidence of Treatment-Emergent Adverse Events (safety and tolerability)
time frame: 30 days post admission
description: Potential harm will be assessed by comparing between-group differences (verum/placebo) of hypothermia and other (serious) adverse events which are not known yet, but will be collected systemically during this trial.
arm group label: Placebo
arm group type: Placebo Comparator
description: InOrpha solution/ml, three times daily with meals for the Treatment period, 7 or 30 days.
arm group label: Capsaicin
arm group type: Experimental
description: InOrpha solution plus 1 mcg Capsaicin/ml, three times daily with meals for the Treatment period of 7 or 30 days.
intervention type: Drug
intervention name: Capsaicin 1% oral solution
description: Capsaicin 1.0 micrograms/ml
arm group label: Capsaicin
intervention type: Drug
intervention name: InOrpha Solution
description: glycerol based suspension vehicle
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Georg kägi, Dr. med.
role: Principal Investigator
affiliation: Cantonal Hospital St. Gallen
last name: Georg Kägi, Dr.med.
phone: +41 71 494 3594
email: georg.kaegi@kssg.ch
last name: Anna Müller, RN
phone: +41 71 494 2958
email: anna.mueller2@kssg.ch
facility: 
status: Recruiting
country: Switzerland
url: https://play.google.com/store/apps/details?id=ch.kssg.press&hl=en_US
description: PRESS App
responsible party type: Sponsor-Investigator
investigator affiliation: Cantonal Hospital of St. Gallen
investigator full name: Georg Kägi, MD
investigator title: Senior Physician and Head of the Stroke Center
mesh term: Deglutition Disorders
mesh term: Stroke
mesh term: Capsaicin
mesh term: Pharmaceutical Solutions
sharing ipd: Yes
ipd description: We plan to upload the study protocol after trial completion
ipd info type: Study Protocol
ipd time frame: after Trial completion indefinitely