<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/NCT04483297</url>
  </required_header>
  <id_info>
    <org_study_id>AK1320-101</org_study_id>
    <nct_id>NCT04483297</nct_id>
  </id_info>
  <brief_title>First-In-Human Study of AK1320 Encapsulated Microspheres (AK1320 MS)</brief_title>
  <acronym>ENHANCE</acronym>
  <official_title>First-In-Human Study of AK1320 Encapsulated Microspheres (AK1320 MS) In Subjects With Degenerative Spondylolisthesis and Concomitant Symptomatic Spinal Stenosis Who Are Undergoing Decompression And Single Level Instrumented Posterolateral Lumbar Autograft Fusion Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asahi Kasei Pharma Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Emergent Clinical Consulting, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Asahi Kasei Pharma Corporation</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>
      The safety and efficacy of AK1320 MS will be evaluated in patients with degenerative&#xD;
      spondylolisthesis and concomitant symptomatic spinal stenosis who are undergoing&#xD;
      decompression and single level instrumented posterolateral lumber autograft fusion surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a first in human Phase I, ascending dose, multi-center, randomized patient study&#xD;
      evaluating the efficacy, safety, PK of AK1320 MS. The study will enroll up to 4 dose&#xD;
      escalating cohorts with each cohort having 2 treatment groups, the AK1320 MS group (n=7) and&#xD;
      the Control group (n=3).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 18, 2020</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events</measure>
    <time_frame>24 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Summary of Neurological Status</measure>
    <time_frame>24 months</time_frame>
    <description>Neurological status will be determined preoperatively and postoperatively using a comprehensive neurological status scale. Neurological status is based on four types of measurements: lower extremity motor, dermatomal sensation, reflexes and straight leg raise.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Successful Fusion</measure>
    <time_frame>24 months</time_frame>
    <description>Fusion will be evaluated through CT scans. Successful fusion will be defined as complete bridging bone between the index level transverse processes with a lack of lucency or lucent lines through the fusion mass.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oswestry Low Back Pain Disability Questionnaire (ODI)</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>36-Item Short Form Survey (SF-36v2®)</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AK1320 plasma concentrations</measure>
    <time_frame>Pre-op(day 0), Post-op (day 0, day1), 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks and 6 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Degenerative Spondylolisthesis</condition>
  <condition>Spinal Stenosis</condition>
  <arm_group>
    <arm_group_label>AK1320 MS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AK1320 MS + Local Autologous Bone + Posterior Fixation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Local Autologous Bone + Posterior Fixation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AK1320 MS</intervention_name>
    <description>AK1320 MS + Local Autologous Bone + Posterior Fixation. Ascending Dose.</description>
    <arm_group_label>AK1320 MS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Local Autologous Bone + Posterior Fixation</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Involved level L1 to S1&#xD;
&#xD;
          2. Use of local autologous bone only.&#xD;
&#xD;
          3. Degenerative spondylolisthesis up to Meyerding's Classification Grade 1 or 2.&#xD;
&#xD;
          4. Moderate or higher disability as assessed by Oswestry Disability Index.&#xD;
&#xD;
          5. Neurogenic claudication and/or radiculopathy with or without back pain.&#xD;
&#xD;
          6. Male or female over 22 years of age and less than 81 years of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior lumbar decompression or spine fusion attempt (any level).&#xD;
&#xD;
          2. Undergoing concurrent interbody fusion.&#xD;
&#xD;
          3. Requires spinal fusion at more than one lumbar level.&#xD;
&#xD;
          4. Degenerative scoliosis.&#xD;
&#xD;
          5. BMI &gt; 40.&#xD;
&#xD;
          6. Radiographically confirmed significant spinal instability.&#xD;
&#xD;
          7. Active or recent (within the past two (2) years) worker's compensation litigation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Royal Alexandra Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T5H 3V9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth II Health Sciences Centre</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 3A7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>London Health Sciences Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A5W9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montreal General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3G 1A4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Sacré-Coeur de Montréal</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4J 1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Québec Laval</name>
      <address>
        <city>Québec</city>
        <state>Quebec</state>
        <zip>G1J1Z4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>January 31, 2023</last_update_submitted>
  <last_update_submitted_qc>January 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>degenerative spondylolisthesis</keyword>
  <keyword>spinal stenosis</keyword>
  <keyword>posterolateral lumber fusion surgery</keyword>
  <keyword>autograft</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Stenosis</mesh_term>
    <mesh_term>Spondylolisthesis</mesh_term>
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_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/NCT04483297
org study id: AK1320-101
nct id: NCT04483297
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The safety and efficacy of AK1320 MS will be evaluated in patients with degenerative
      spondylolisthesis and concomitant symptomatic spinal stenosis who are undergoing
      decompression and single level instrumented posterolateral lumber autograft fusion surgery.
This will be a first in human Phase I, ascending dose, multi-center, randomized patient study
      evaluating the efficacy, safety, PK of AK1320 MS. The study will enroll up to 4 dose
      escalating cohorts with each cohort having 2 treatment groups, the AK1320 MS group (n=7) and
      the Control group (n=3).
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events
time frame: 24 months
measure: Summary of Neurological Status
time frame: 24 months
description: Neurological status will be determined preoperatively and postoperatively using a comprehensive neurological status scale. Neurological status is based on four types of measurements: lower extremity motor, dermatomal sensation, reflexes and straight leg raise.
measure: Successful Fusion
time frame: 24 months
description: Fusion will be evaluated through CT scans. Successful fusion will be defined as complete bridging bone between the index level transverse processes with a lack of lucency or lucent lines through the fusion mass.
measure: Oswestry Low Back Pain Disability Questionnaire (ODI)
time frame: 24 months
measure: 36-Item Short Form Survey (SF-36v2®)
time frame: 24 months
measure: AK1320 plasma concentrations
time frame: Pre-op(day 0), Post-op (day 0, day1), 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks and 6 weeks
arm group label: AK1320 MS
arm group type: Experimental
description: AK1320 MS + Local Autologous Bone + Posterior Fixation
arm group label: Control
arm group type: Other
description: Local Autologous Bone + Posterior Fixation
intervention type: Drug
intervention name: AK1320 MS
description: AK1320 MS + Local Autologous Bone + Posterior Fixation. Ascending Dose.
arm group label: AK1320 MS
intervention type: Other
intervention name: Control
description: Local Autologous Bone + Posterior Fixation
arm group label: Control
criteria: 
gender: All
minimum age: 22 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Spinal Stenosis
mesh term: Spondylolisthesis
mesh term: Constriction, Pathologic
sharing ipd: No