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/NCT05965700</url>
    </required_header>
    <id_info>
      <org_study_id>NVG-291-201</org_study_id>
      <nct_id>NCT05965700</nct_id>
    </id_info>
    <brief_title>NVG-291 in Spinal Cord Injury Subjects</brief_title>
    <official_title>A Randomized, Double-Blind, Placebo-Controlled Phase 1b/2a Study of NVG-291 in Spinal Cord Injury Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>NervGen Pharma</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>NervGen Pharma</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>
        A Single site (Shirley Ryan AbilityLab) Randomized, Double-Blind, Placebo-Controlled Phase&#xD;
        1b/2a Study of NVG-291 in Spinal Cord Injury Subjects&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        To evaluate the effect of NVG-291 on descending connectivity in subjects with subacute and&#xD;
        chronic SCI (20 subjects per Cohort and results will be analyzed separately) using objective&#xD;
        electrophysiological measures, in addition to clinical assessments. To evaluate safety and&#xD;
        tolerability of NVG-291 in a SCI population, as measured by clinical assessments (Physical&#xD;
        Examination, Vital Signs, ECG, etc.) as well as clinical laboratory measures.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 8, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2024</primary_completion_date>
    <phase>Phase 1/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>
      <intervention_model_description>Randomized, Double-Blind, Placebo-Controlled</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Electrophysiological</measure>
      <time_frame>16 weeks</time_frame>
      <description>MEP amplitudes (corticospinal contribution)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>10mWT time</measure>
      <time_frame>16 weeks</time_frame>
      <description>Walking speed</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>9-HPT time</measure>
      <time_frame>16 weeks</time_frame>
      <description>Upper extremity dexterity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pinch dynamometry</measure>
      <time_frame>16 weeks</time_frame>
      <description>Recorded force</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Graded and Redefined Assessment of Strength, Sensibility, and Prehension Test</measure>
      <time_frame>16 weeks</time_frame>
      <description>Hand function Max Score 116 points (higher is better)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lower extremity motor score (LEMS)</measure>
      <time_frame>16 weeks</time_frame>
      <description>Lower extremity Max Score 50 points (25 points per side - higher is better)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Upper extremity motor score (UEMS)</measure>
      <time_frame>16 weeks</time_frame>
      <description>Upper extremity Max Score 50 points (25 points per side - higher is better)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Spinal Cord Injuries</condition>
    <condition>Chronic Spinal Cord Injury</condition>
    <condition>Subacute Spinal Cord Injury</condition>
    <arm_group>
      <arm_group_label>NVG-291 for Injection</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Injected under the skin (subcutaneous).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Injected under the skin (subcutaneous).</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>NVG-291</intervention_name>
      <description>A once daily injection</description>
      <arm_group_label>NVG-291 for Injection</arm_group_label>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          A subject must provide written informed consent in accordance with local regulations prior&#xD;
          to initiation of any study-specific activities/procedures. A legally authorized&#xD;
          representative (LAR) may be used to assist in signing the informed consent.&#xD;
  &#xD;
          Cervical SCI resulting from acute physical trauma.&#xD;
  &#xD;
          Males and females&#xD;
  &#xD;
          Age 18 - 75 years, inclusive.&#xD;
  &#xD;
          Cervical SCI, incomplete, with a neurological level of injury being at C7 or higher.&#xD;
  &#xD;
          Had incomplete cervical SCI within the period from 1 year to 10 years inclusive (Chronic&#xD;
          cohort 1) OR within 10 days to 49 days inclusive (Subacute cohort 2) at time of&#xD;
          randomization.&#xD;
  &#xD;
          Must be able to volitionally initiate at least one step on one leg (without body weight&#xD;
          support).&#xD;
  &#xD;
          Must have a Walking Index for Spinal Cord Injury II (WISCI II) score as follows:&#xD;
  &#xD;
            1. For Chronic cohort 1: Less than or equal to Level 14.&#xD;
  &#xD;
            2. For Subacute cohort 2: Less than or equal to Level 8.&#xD;
  &#xD;
          GRASSP Prehension Ability score&#xD;
  &#xD;
          For Chronic cohort 1:&#xD;
  &#xD;
          i. Must have a score of at least 2 on at least one of the Prehension Ability grasp patterns&#xD;
          of the GRASSP assessment in at least one upper extremity. ii. Must have no more than one&#xD;
          Prehension Ability grasp patterns score = 4 in the upper extremity satisfying criterion i&#xD;
  &#xD;
          For Subacute cohort 2:&#xD;
  &#xD;
          i. Must have a score of 2 on at least one of the Prehension Ability grasp patterns of the&#xD;
          GRASSP assessment in at least one upper extremity. ii. Must have no more than one&#xD;
          Prehension Ability grasp patterns score = 3 in the upper extremity satisfying criterion i.&#xD;
          iii. Must not have a Prehension Ability grasp patterns score = 4 in the upper extremity&#xD;
          satisfying criterion i.&#xD;
  &#xD;
          Must be fluent in English.&#xD;
  &#xD;
          Subjects must be willing and able to comply with scheduled visits, all sample collections,&#xD;
          and other trial procedures.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Nontraumatic SCI (e.g., due to infection, ischemia, metabolic abnormality, congenital&#xD;
          abnormality, malignancy, radiation injury, or other disease process).&#xD;
  &#xD;
          Spinal cord injury due to gunshot wound or penetrating injury.&#xD;
  &#xD;
          Two or more (noncontiguous) spinal cord lesions.&#xD;
  &#xD;
          MRI evidence of anatomically complete spinal cord transection.&#xD;
  &#xD;
          Any form of ventilatory dependence.&#xD;
  &#xD;
          Any condition that precludes adequate clinical assessment of all four extremities, such as&#xD;
          contracture, peripheral nerve injury, amputation.&#xD;
  &#xD;
          History of seizures (febrile seizures allowed).&#xD;
  &#xD;
          Metal implant in the head.&#xD;
  &#xD;
          History of traumatic brain injury without recovery.&#xD;
  &#xD;
          Any neurological condition that may interfere with performance or confound assessment, such&#xD;
          as multiple sclerosis, stroke, or syringomyelia.&#xD;
  &#xD;
          History of substance abuse within 12 months prior to screening, based on medical records or&#xD;
          self-report.&#xD;
  &#xD;
          Evidence of spinal instability or persistent spinal stenosis and/or compression related to&#xD;
          initial trauma.&#xD;
  &#xD;
          Prior treatment with cell therapy delivered into the CNS (intrathecal or intraparenchymal).&#xD;
  &#xD;
          Severe neuropathic pain inadequately controlled by medication.&#xD;
  &#xD;
          Body mass index (BMI) &gt; 40 (body weight in kilograms divided by height in meters squared).&#xD;
  &#xD;
          Received botulinum toxin injection(s) in an upper or lower extremity muscle in the prior 6&#xD;
          months.&#xD;
  &#xD;
          Received 4-aminopyridine within 14 days of screening.&#xD;
  &#xD;
          Prior treatment with a protein tyrosine phosphatase sigma (PTPσ) mimetic peptide.&#xD;
  &#xD;
          Intrathecal opioid use.&#xD;
  &#xD;
          Currently participating in an interventional clinical trial.&#xD;
  &#xD;
          Received a non-permitted medication within 5.5 half-lives or 7 days, whichever is longer,&#xD;
          prior to randomization&#xD;
  &#xD;
          Receiving any treatment intended to enhance neuroplasticity (e.g., electrical stimulation,&#xD;
          acute intermittent hypoxia) at the time of consent to participate in this study or within 4&#xD;
          weeks of randomization, whichever is longer.&#xD;
  &#xD;
          Any implanted internal spinal cord stimulator.&#xD;
  &#xD;
          Currently receiving neuromuscular stimulation.&#xD;
  &#xD;
          Currently receiving vagal nerve stimulation.&#xD;
  &#xD;
          Any contraindication to undergo MRI studies such as:&#xD;
  &#xD;
            1. History of a cardiac pacemaker or pacemaker wires, OR&#xD;
  &#xD;
            2. Metallic particles in the body, OR&#xD;
  &#xD;
            3. Baclofen pump, OR&#xD;
  &#xD;
            4. Vascular clips in the head, OR&#xD;
  &#xD;
            5. Prosthetic heart valves, OR&#xD;
  &#xD;
            6. Severe claustrophobia impeding ability to participate in an imaging study.&#xD;
  &#xD;
          Malignancy within 5 years prior to screening, except for non-melanoma skin cancers or&#xD;
          cervical or breast ductal carcinoma in situ.&#xD;
  &#xD;
          Severe renal insufficiency, as defined by eGFR &lt; 30 mL/min/1.73m2.&#xD;
  &#xD;
          Any other social or medical condition (e.g., uncontrolled diabetes, unstable hypertension)&#xD;
          which, in the opinion of the investigator, would make the subject unsuitable for study&#xD;
          participation.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Daniel Mikol, M.D. Ph.D.</last_name>
      <role>Study Director</role>
      <affiliation>NervGen Pharma</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>SRI Ramya Vemulakonda</last_name>
      <phone>844-355-2253</phone>
      <email>svemulakon@sralab.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Meghan Morrow</last_name>
      <phone>844-355-2253</phone>
      <email>mmorrow02@sralab.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Shirley Ryan AbilityLab</name>
        <address>
          <city>Chicago</city>
          <state>Illinois</state>
          <zip>60611</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>SRI Ramya Vemulakonda</last_name>
        <phone>844-355-2253</phone>
        <email>svemulakon@sralab.org</email>
      </contact>
      <contact_backup>
        <last_name>Meghan Morrow</last_name>
        <phone>1-844-355-2253</phone>
        <email>mmorrow02@sralab.org</email>
      </contact_backup>
      <investigator>
        <last_name>Monica A Perez, PT, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>David Chen, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 16, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Spinal Cord Injury</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Spinal Cord Injuries</mesh_term>
      <mesh_term>Wounds and Injuries</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/NCT05965700
  org study id: NVG-291-201
  nct id: NCT05965700
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  A Single site (Shirley Ryan AbilityLab) Randomized, Double-Blind, Placebo-Controlled Phase
        1b/2a Study of NVG-291 in Spinal Cord Injury Subjects
  To evaluate the effect of NVG-291 on descending connectivity in subjects with subacute and
        chronic SCI (20 subjects per Cohort and results will be analyzed separately) using objective
        electrophysiological measures, in addition to clinical assessments. To evaluate safety and
        tolerability of NVG-291 in a SCI population, as measured by clinical assessments (Physical
        Examination, Vital Signs, ECG, etc.) as well as clinical laboratory measures.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized, Double-Blind, Placebo-Controlled
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Electrophysiological
  time frame: 16 weeks
  description: MEP amplitudes (corticospinal contribution)
  measure: 10mWT time
  time frame: 16 weeks
  description: Walking speed
  measure: 9-HPT time
  time frame: 16 weeks
  description: Upper extremity dexterity
  measure: Pinch dynamometry
  time frame: 16 weeks
  description: Recorded force
  measure: Graded and Redefined Assessment of Strength, Sensibility, and Prehension Test
  time frame: 16 weeks
  description: Hand function Max Score 116 points (higher is better)
  measure: Lower extremity motor score (LEMS)
  time frame: 16 weeks
  description: Lower extremity Max Score 50 points (25 points per side - higher is better)
  measure: Upper extremity motor score (UEMS)
  time frame: 16 weeks
  description: Upper extremity Max Score 50 points (25 points per side - higher is better)
  arm group label: NVG-291 for Injection
  arm group type: Experimental
  description: Injected under the skin (subcutaneous).
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Injected under the skin (subcutaneous).
  intervention type: Drug
  intervention name: NVG-291
  description: A once daily injection
  arm group label: NVG-291 for Injection
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Daniel Mikol, M.D. Ph.D.
  role: Study Director
  affiliation: NervGen Pharma
  last name: SRI Ramya Vemulakonda
  phone: 844-355-2253
  email: svemulakon@sralab.org
  last name: Meghan Morrow
  phone: 844-355-2253
  email: mmorrow02@sralab.org
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Spinal Cord Injuries
  mesh term: Wounds and Injuries
  sharing ipd: No