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/NCT06022263</url>
    </required_header>
    <id_info>
      <org_study_id>STA-LDH01</org_study_id>
      <nct_id>NCT06022263</nct_id>
    </id_info>
    <brief_title>STA363 in the Treatment of Lumbar Disc Herniation</brief_title>
    <official_title>A Prospective, Randomised, Double-blinded, Placebo-controlled Study Investigating the Safety and Tolerability of STA363 in Patients With Radiculopathy Caused by Lumbar Disc Herniation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Stayble Therapeutics</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Cromsource</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
      <collaborator>
        <agency>Antaros Medical</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
      <collaborator>
        <agency>VIEDOC</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Stayble Therapeutics</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 goal of this clinical trial is to establish safety and tolerability of STA363 injected&#xD;
        into a herniated intervertebral disc in patients with sciatica due to disc herniation. The&#xD;
        main questions the trial aims to answer are:&#xD;
  &#xD;
          1. Is the treatment safe and tolerable?&#xD;
  &#xD;
          2. Does the volume of the disc and the herniation decrease?&#xD;
  &#xD;
          3. Is sciatica reduced? Participants will be given an injection into the herniated disc of&#xD;
             either placebo or STA363 (one dose).&#xD;
  &#xD;
        Researchers will compare safety, tolerability, effects on disc and herniation volume and on&#xD;
        symptoms between the group of patients injected with placebo and the group injected with&#xD;
        STA363.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will include 24 patients, recruited at 4 different sites, suffering from&#xD;
        radiculopathy due to lumbar disc herniation (LDH). Patients will be screened for symptoms,&#xD;
        disease history and magnetic resonance imaging (MRI) evidence of LDH. Baseline data (e.g.&#xD;
        pain recording and MRI data) will be collected, and 1/3 of the patients will then be&#xD;
        randomized to intradiscal injection with placebo (Omnipaque with water for injection, 1.5 mL)&#xD;
        and 2/3 of the patients will be randomized to STA363 (lactic acid, 120 mg/mL with Omnipaque,&#xD;
        1.5 mL). The injections will be done using fluoroscopic guidance, and the patients will be&#xD;
        treated with intravenous antibiotics and sedatives. The first follow-up will be done by phone&#xD;
        1 week after the treatment, while the other follow-ups will be physical visits at month 1, 3&#xD;
        and 6 at the site. In conjunction with the visits, the patient will record daily pain&#xD;
        intensity (Numerical Rating Scale) for 7 days using an eDiary, and MRI will be performed. The&#xD;
        primary completion time i 6 months with the primary objectives safety and tolerability.&#xD;
        Important secondary objectives will be changes of disc volume and pain.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 25, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 31, 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>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Safety and tolerability</measure>
      <time_frame>Baseline and 1 week and 1,3 and 6 months after intervention for all outcomes except changes in IVD morphology (time frame 1, 3 and 6 months after intervention)</time_frame>
      <description>Safety and tolerability will be measured using the following outcomes:&#xD;
  Incidence and nature of adverse events (AEs)&#xD;
  Changes in&#xD;
  physical examination findings&#xD;
  blood pressure and heart rate&#xD;
  12-lead electrocardiogram&#xD;
  Hematology and clinical chemistry&#xD;
  Pain intensity at the injection site during and 15 minutes after injection (numerical rating scale; NRS). NRS is reported on a 0-10 scale where 0 represents &quot;No pain&quot; and 10 &quot;Worst imaginable pain&quot;&#xD;
  Other aspects of intervertebral disc morphology (IVD) morphology from baseline (e.g., Modic changes)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Disc volume</measure>
      <time_frame>Baseline and 1,3 and 6 months after intervention</time_frame>
      <description>Volume will be measured by MRI</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disc height</measure>
      <time_frame>Baseline and 1,3 and 6 months after intervention</time_frame>
      <description>Height will be measured by MRI</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Radicular leg pain</measure>
      <time_frame>Baseline and 1 week and 1,3 and 6 months after intervention</time_frame>
      <description>Leg pain will be reported by the patients using an NRS. (minimum value: 0; maximum value: 10) for 7 consecutive days. Lower scores means a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Global Impression of Change (PGIC)</measure>
      <time_frame>Baseline and 1 week and 1,3 and 6 months after intervention</time_frame>
      <description>PGIC will be reported by the patients using an electronic device</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disc intensity</measure>
      <time_frame>Baseline and 1,3 and 6 months after intervention</time_frame>
      <description>The intensity of the disc will be measured using T2-weighted MRI</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Lumbar Disc Herniation</condition>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>1.5 mL of Omnipaque mixed with water for injection</description>
    </arm_group>
    <arm_group>
      <arm_group_label>STA363</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>1.5 mL of STA363 (lactic acid, 120 mg/mL) mixed with Omnipaque</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Lactic Acid</intervention_name>
      <description>180 mg of STA363 will be slowly injected into a symptom-generating herniated lumbar disc</description>
      <arm_group_label>STA363</arm_group_label>
      <other_name>STA363</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>1.5 mL of Omnipaque in water for injection will be slowly injected into a symptom-generating herniated lumbar disc</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Signed informed consent prior to any study-related procedures&#xD;
  &#xD;
            2. Patient has a single subligamentous posteriolateral lumbar disc herniation (protrusion&#xD;
               or extrusion) of any lumbar disc below L1/L2 diagnosed by clinical symptoms and/or&#xD;
               physical findings and confirmed by MRI&#xD;
  &#xD;
            3. Patient has symptoms and/or physical findings consistent with a unilateral&#xD;
               radiculopathy affecting one nerve root (L2-L5)&#xD;
  &#xD;
            4. Patient has leg pain of the dermatome consistent with the nerve root affected by the&#xD;
               herniation&#xD;
  &#xD;
            5. The herniated disc is 3 or lower on the Pfirrmann scale (grade 1-5)&#xD;
  &#xD;
            6. Patient has experienced symptoms of a herniated disc for at least 6 weeks prior to&#xD;
               randomisation without sufficient relief with pain medications and other conservative&#xD;
               therapies&#xD;
  &#xD;
            7. Ability to understand the written and verbal information about the study&#xD;
  &#xD;
            8. Male and female patients 18 years or older but 50 years or younger&#xD;
  &#xD;
            9. Women of childbearing potential eligible if using effective contraceptives&#xD;
  &#xD;
           10. Patient has a body mass index (BMI) of ≥18 to ≤35 kg/m2&#xD;
  &#xD;
           11. Patients who meet all the following NRS selection criteria for radicular leg pain:&#xD;
  &#xD;
                 1. Presence of at least 5 pain NRS assessments (entries) for 7 consecutive days&#xD;
  &#xD;
                 2. NRS daily pain scores between 3-9&#xD;
  &#xD;
                 3. Not more than 2 NRS scores of &quot;3&quot;&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            1. Treatment with any investigational product within 3 months prior to the screening&#xD;
               visit&#xD;
  &#xD;
            2. Patient has a sequestered lumbar disc herniation or transligamentous/ herniation&#xD;
               confirmed by MRI&#xD;
  &#xD;
            3. Patient has a bulging disc&#xD;
  &#xD;
            4. Patient has experienced symptoms of lumbar disc herniation for more than 6 months&#xD;
  &#xD;
            5. Patient has 2 or more symptomatic lumbar disc herniations (presence of non-symptomatic&#xD;
               herniations in addition to the symptomatic herniation is allowed)&#xD;
  &#xD;
            6. Patient has cauda equina syndrome&#xD;
  &#xD;
            7. Previous intradiscal therapeutic intervention of the index disc or has had any lumbar&#xD;
               spine surgery&#xD;
  &#xD;
            8. Presence of lumbar spine disease and/or clinically significant deformity other than a&#xD;
               lumbar disc herniation which, in the opinion of the investigator, will affect&#xD;
               evaluation of safety and/or efficacy&#xD;
  &#xD;
            9. Untreated, ongoing active infection and/or discitis&#xD;
  &#xD;
           10. Current infection or prior history of spinal infection (e.g., discitis, septic&#xD;
               arthritis, epidural abscess) or an active systemic infection.&#xD;
  &#xD;
           11. Evidence of prior lumbar vertebral body fracture or trauma.&#xD;
  &#xD;
           12. Spondylolisthesis or retrolisthesis grade 2 and above or spondylolysis at the index or&#xD;
               adjacent level(s).&#xD;
  &#xD;
           13. Lumbar spondylitis or other undifferentiated spondyloarthropathy affecting the index&#xD;
               disc.&#xD;
  &#xD;
           14. Patients previously included in the study.&#xD;
  &#xD;
           15. Patients suffering from psychosomatic pain in the opinion of the Investigator.&#xD;
  &#xD;
           16. Patients requiring continuous treatment with warfarin or other anticoagulant therapy.&#xD;
  &#xD;
           17. Known alcohol and/or drug abuse.&#xD;
  &#xD;
           18. Pregnant or lactating females, or intention to become pregnant within the study&#xD;
               period.&#xD;
  &#xD;
           19. Known allergy or intolerance to the contrast agent Omnipaque®.&#xD;
  &#xD;
           20. Known opioid allergy or intolerance.&#xD;
  &#xD;
           21. Any other condition that, in the opinion of the Investigator, precludes the patient&#xD;
               from taking part in this study.&#xD;
  &#xD;
           22. Any specific contraindication for MRI such as claustrophobia, intracranial clips or&#xD;
               pacemakers.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jarkko Kalliomäki, MD, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Stayble Therapeutics AB</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Tomasz Blicharski, MD, PhD</last_name>
      <phone>+48509678110</phone>
      <email>blicharski@vp.pl</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Radoslaw Rola, MD, PhD</last_name>
      <phone>+48817144176</phone>
      <email>rola.radoslaw@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Ortopedii i Rehabilitacji</name>
        <address>
          <city>Lublin</city>
          <state>Lubelskie</state>
          <zip>20-002</zip>
          <country>Poland</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Poland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Lumbar radiculopathy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Intervertebral Disc Displacement</mesh_term>
      <mesh_term>Hernia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06022263
  org study id: STA-LDH01
  nct id: NCT06022263
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to establish safety and tolerability of STA363 injected
        into a herniated intervertebral disc in patients with sciatica due to disc herniation. The
        main questions the trial aims to answer are:
  
          1. Is the treatment safe and tolerable?
  
          2. Does the volume of the disc and the herniation decrease?
  
          3. Is sciatica reduced? Participants will be given an injection into the herniated disc of
             either placebo or STA363 (one dose).
  
        Researchers will compare safety, tolerability, effects on disc and herniation volume and on
        symptoms between the group of patients injected with placebo and the group injected with
        STA363.
  The study will include 24 patients, recruited at 4 different sites, suffering from
        radiculopathy due to lumbar disc herniation (LDH). Patients will be screened for symptoms,
        disease history and magnetic resonance imaging (MRI) evidence of LDH. Baseline data (e.g.
        pain recording and MRI data) will be collected, and 1/3 of the patients will then be
        randomized to intradiscal injection with placebo (Omnipaque with water for injection, 1.5 mL)
        and 2/3 of the patients will be randomized to STA363 (lactic acid, 120 mg/mL with Omnipaque,
        1.5 mL). The injections will be done using fluoroscopic guidance, and the patients will be
        treated with intravenous antibiotics and sedatives. The first follow-up will be done by phone
        1 week after the treatment, while the other follow-ups will be physical visits at month 1, 3
        and 6 at the site. In conjunction with the visits, the patient will record daily pain
        intensity (Numerical Rating Scale) for 7 days using an eDiary, and MRI will be performed. The
        primary completion time i 6 months with the primary objectives safety and tolerability.
        Important secondary objectives will be changes of disc volume and pain.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Safety and tolerability
  time frame: Baseline and 1 week and 1,3 and 6 months after intervention for all outcomes except changes in IVD morphology (time frame 1, 3 and 6 months after intervention)
  description: Safety and tolerability will be measured using the following outcomes:
  Incidence and nature of adverse events (AEs)
  Changes in
  physical examination findings
  blood pressure and heart rate
  12-lead electrocardiogram
  Hematology and clinical chemistry
  Pain intensity at the injection site during and 15 minutes after injection (numerical rating scale; NRS). NRS is reported on a 0-10 scale where 0 represents "No pain" and 10 "Worst imaginable pain"
  Other aspects of intervertebral disc morphology (IVD) morphology from baseline (e.g., Modic changes)
  measure: Disc volume
  time frame: Baseline and 1,3 and 6 months after intervention
  description: Volume will be measured by MRI
  measure: Disc height
  time frame: Baseline and 1,3 and 6 months after intervention
  description: Height will be measured by MRI
  measure: Radicular leg pain
  time frame: Baseline and 1 week and 1,3 and 6 months after intervention
  description: Leg pain will be reported by the patients using an NRS. (minimum value: 0; maximum value: 10) for 7 consecutive days. Lower scores means a better outcome.
  measure: Patient Global Impression of Change (PGIC)
  time frame: Baseline and 1 week and 1,3 and 6 months after intervention
  description: PGIC will be reported by the patients using an electronic device
  measure: Disc intensity
  time frame: Baseline and 1,3 and 6 months after intervention
  description: The intensity of the disc will be measured using T2-weighted MRI
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: 1.5 mL of Omnipaque mixed with water for injection
  arm group label: STA363
  arm group type: Experimental
  description: 1.5 mL of STA363 (lactic acid, 120 mg/mL) mixed with Omnipaque
  intervention type: Drug
  intervention name: Lactic Acid
  description: 180 mg of STA363 will be slowly injected into a symptom-generating herniated lumbar disc
  arm group label: STA363
  other name: STA363
  intervention type: Drug
  intervention name: Placebo
  description: 1.5 mL of Omnipaque in water for injection will be slowly injected into a symptom-generating herniated lumbar disc
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: No
  last name: Jarkko Kalliomäki, MD, PhD
  role: Study Director
  affiliation: Stayble Therapeutics AB
  last name: Tomasz Blicharski, MD, PhD
  phone: +48509678110
  email: blicharski@vp.pl
  last name: Radoslaw Rola, MD, PhD
  phone: +48817144176
  email: rola.radoslaw@gmail.com
  facility: 
  status: Recruiting
  country: Poland
  responsible party type: Sponsor
  mesh term: Intervertebral Disc Displacement
  mesh term: Hernia
  sharing ipd: No