<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/NCT01714089</url>
  </required_header>
  <id_info>
    <org_study_id>06.1.1.H1</org_study_id>
    <nct_id>NCT01714089</nct_id>
  </id_info>
  <brief_title>Proof of Concept Study Evaluating RNS60 in the Treatment of Relapsing Remitting Multiple Sclerosis</brief_title>
  <official_title>A Phase II Study Evaluating RNS60 Compared to Interferon Beta-1a (Avonex) for the Treatment of Relapsing Remitting Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Revalesio Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Revalesio Corporation</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether RNS60 is effective in the treatment of&#xD;
      RR-MS compared to interferon beta-1a.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in number of GAD-enhancing lesions from baseline</measure>
    <time_frame>3, 4, 5, and 6 months</time_frame>
    <description>Cumulative number of GAD-enhancing lesions by MRI at months 3, 4, 5, and 6</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in number of T2 lesions from baseline</measure>
    <time_frame>Months 3, 4, 5, and 6</time_frame>
    <description>Cumulative number of new or newly enlarged T2 lesions over 6 months of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brain volume</measure>
    <time_frame>6 months</time_frame>
    <description>Brain volume by MRI over 6 months of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T2 lesion volume</measure>
    <time_frame>6 month</time_frame>
    <description>T2 lesion volume by MRI over 6 months of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annualized Relapse Rate</measure>
    <time_frame>6 months</time_frame>
    <description>Annualized Relapse Rate over 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expanded Disability Status Scale (EDSS), change from baseline</measure>
    <time_frame>3, 6 months</time_frame>
    <description>Progression of disability as assessed by the Expanded Disability Status Scale at months 3 and 6.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multiple Sclerosis Functional Composite, change from baseline</measure>
    <time_frame>3, 6 months</time_frame>
    <description>Progression of disability as assessed by the Multiple Sclerosis Functional Composite tool at months 3 and 6 months.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Relapsing Remitting Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>RNS60 125 ml</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>125 ml of RNS60 administered weekly by IV infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RNS60 250 ml</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>250 ml of RNS60 administered weekly by IV infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Interferon beta-1a</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Weekly dose of 30 mcg Interferon beta-1a (Avonex) administered by intramuscular injection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RNS60 125 ml</intervention_name>
    <arm_group_label>RNS60 125 ml</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RNS60 250 ml</intervention_name>
    <arm_group_label>RNS60 250 ml</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Interferon beta 1a</intervention_name>
    <arm_group_label>Interferon beta-1a</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males or females, aged between 18 and 50 years.&#xD;
&#xD;
          2. Diagnosis of RR-MS according to McDonald 2010 diagnostic criteria with a prior brain&#xD;
             MRI that demonstrates lesions consistent with RRMS, both within the past year.&#xD;
&#xD;
          3. No evidence of relapse during the 60 days prior to enrollment.&#xD;
&#xD;
          4. EDSS score of 0-5 at screening.&#xD;
&#xD;
          5. Women of childbearing potential who have a negative pregnancy test (serum HCG) at&#xD;
             screening.&#xD;
&#xD;
          6. Men or women of reproductive potential who commit to use adequate contraception during&#xD;
             the study and for 1 month following the last day of treatment.&#xD;
&#xD;
          7. Subjects must be capable of understanding the purpose and risks of the study and&#xD;
             provide written, informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of Secondary Progressive MS, Primary Progressive MS or Progressive Relapsing&#xD;
             MS.&#xD;
&#xD;
          2. Normal baseline brain MRI.&#xD;
&#xD;
          3. History of any clinically significant autoimmune disease: inflammatory bowel disease,&#xD;
             diabetes, lupus or severe asthma.&#xD;
&#xD;
          4. Current or prior malignancies (excluding non-melanoma skin carcinoma or in situ&#xD;
             carcinoma of the cervix that has been adequately treated.)&#xD;
&#xD;
          5. Significant organ dysfunction, including cardiac, renal (eGFR ≤ 60 ml/min.), liver,&#xD;
             central nervous system, pulmonary, vascular, gastrointestinal, endocrine, or metabolic&#xD;
             (e.g., creatinine ≥ 1.6 mg/dL; ALT or AST ≥ 1.5x the upper limit of normal), history&#xD;
             of myocardial infarction, congestive heart failure, or arrhythmias within 6 months&#xD;
             prior to enrollment.&#xD;
&#xD;
          6. Steroid therapy within 60 days prior to enrollment, with the exception of&#xD;
             corticosteroids or ACTH for relapse treatment during the course of the study.&#xD;
&#xD;
          7. Known allergy to Gadolinium-DTPA&#xD;
&#xD;
          8. Therapy with any immunomodulatory drugs within 3 months prior to enrollment, including&#xD;
             but not limited to interferons, glatiramir acetate, BG-12, teriflunomide, laquinimod&#xD;
             and IV immunoglobulin.&#xD;
&#xD;
          9. Treatment at any time with immunosuppressive drugs such as cladribine, total lymphoid&#xD;
             irradiation, monoclonal antibody treatment, mitoxantrone, Tysabri, fingolimod,&#xD;
             cytoxan, methotrexate.&#xD;
&#xD;
         10. Participation in any investigational therapy within one year prior to enrollment,&#xD;
             unless given approval by PI.&#xD;
&#xD;
         11. Known or suspected current or past alcohol or drug abuse within one year prior to&#xD;
             enrollment.&#xD;
&#xD;
         12. Any medical, psychiatric or other condition that could result in a subject not being&#xD;
             able to comply with protocol requirements.&#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>Fred Lublin, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mt. Sinai School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mt. Sinai School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <last_update_submitted>April 5, 2016</last_update_submitted>
  <last_update_submitted_qc>April 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Relapsing remitting multiple sclerosis</keyword>
  <keyword>RR-MS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Multiple Sclerosis, Relapsing-Remitting</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Interferons</mesh_term>
    <mesh_term>Interferon-beta</mesh_term>
    <mesh_term>Interferon beta-1a</mesh_term>
    <mesh_term>RNS60</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01714089
org study id: 06.1.1.H1
nct id: NCT01714089
lead sponsor: 
The purpose of this study is to determine whether RNS60 is effective in the treatment of
      RR-MS compared to interferon beta-1a.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Change in number of GAD-enhancing lesions from baseline
time frame: 3, 4, 5, and 6 months
description: Cumulative number of GAD-enhancing lesions by MRI at months 3, 4, 5, and 6
measure: Change in number of T2 lesions from baseline
time frame: Months 3, 4, 5, and 6
description: Cumulative number of new or newly enlarged T2 lesions over 6 months of treatment
measure: Brain volume
time frame: 6 months
description: Brain volume by MRI over 6 months of treatment
measure: T2 lesion volume
time frame: 6 month
description: T2 lesion volume by MRI over 6 months of treatment
measure: Annualized Relapse Rate
time frame: 6 months
description: Annualized Relapse Rate over 6 months
measure: Expanded Disability Status Scale (EDSS), change from baseline
time frame: 3, 6 months
description: Progression of disability as assessed by the Expanded Disability Status Scale at months 3 and 6.
measure: Multiple Sclerosis Functional Composite, change from baseline
time frame: 3, 6 months
description: Progression of disability as assessed by the Multiple Sclerosis Functional Composite tool at months 3 and 6 months.
arm group label: RNS60 125 ml
arm group type: Experimental
description: 125 ml of RNS60 administered weekly by IV infusion
arm group label: RNS60 250 ml
arm group type: Experimental
description: 250 ml of RNS60 administered weekly by IV infusion
arm group label: Interferon beta-1a
arm group type: Active Comparator
description: Weekly dose of 30 mcg Interferon beta-1a (Avonex) administered by intramuscular injection.
intervention type: Drug
intervention name: RNS60 125 ml
arm group label: RNS60 125 ml
intervention type: Drug
intervention name: RNS60 250 ml
arm group label: RNS60 250 ml
intervention type: Drug
intervention name: Interferon beta 1a
arm group label: Interferon beta-1a
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Fred Lublin, MD, PhD
role: Principal Investigator
affiliation: Mt. Sinai School of Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Multiple Sclerosis, Relapsing-Remitting
mesh term: Sclerosis
mesh term: Interferons
mesh term: Interferon-beta
mesh term: Interferon beta-1a
mesh term: RNS60