<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/NCT03802565</url>
  </required_header>
  <id_info>
    <org_study_id>201</org_study_id>
    <nct_id>NCT03802565</nct_id>
  </id_info>
  <brief_title>Tolperisone in Acute Muscle Spasm of the Back</brief_title>
  <acronym>STAR</acronym>
  <official_title>Dose Ranging Study of Tolperisone in Acute Muscle Spasm of the Back</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Neurana Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Neurana Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>No</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>
      This is a double-blind, randomized, placebo-controlled, parallel group study of the efficacy&#xD;
      and safety of tolperisone (a non-opioid) or placebo administered as multiple doses three&#xD;
      times a day (TID) in approximately 400 male and female subjects experiencing back pain due to&#xD;
      or associated with muscle spasm.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">July 12, 2019</completion_date>
  <primary_completion_date type="Actual">June 28, 2019</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Effect Size in Subjected-Rated Pain</measure>
    <time_frame>Day 1 to Day 14</time_frame>
    <description>Mean effect size between Tolperisone and Placebo of subject-rated pain due to acute back spasm using a Numerical Rating Scale (NRS; 0-10 scale, from no pain to worst possible pain) on Day 14 &quot;right now.&quot;</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">415</enrollment>
  <condition>Back Pain</condition>
  <condition>Acute Pain</condition>
  <condition>Back Spasm Upper Back</condition>
  <condition>Back Strain</condition>
  <condition>Muscle Cramp</condition>
  <condition>Muscle Spasm</condition>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Tolperisone 50 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TID (150 mg/day)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tolperisone 100 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TID (300 mg/day)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tolperisone 150 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TID (450 mg/day)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tolperisone 200 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TID (600 mg/day)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>TID</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tolperisone</intervention_name>
    <description>TID</description>
    <arm_group_label>Tolperisone 100 mg</arm_group_label>
    <arm_group_label>Tolperisone 150 mg</arm_group_label>
    <arm_group_label>Tolperisone 200 mg</arm_group_label>
    <arm_group_label>Tolperisone 50 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ambulatory&#xD;
&#xD;
          -  Current acute back pain and/or stiffness due to acute and painful muscle spasm&#xD;
             starting within 7 days prior to study entry and more than 8 weeks after the last&#xD;
             episode of acute back pain.&#xD;
&#xD;
          -  Pain of 4 or more on the subject &quot;right now&quot; rating of pain intensity Numeric Rating&#xD;
             Scale (NRS) scale of 0-10.&#xD;
&#xD;
          -  Willing to discontinue all medication used for the treatment of pain or muscle spasm&#xD;
             on study entry.&#xD;
&#xD;
          -  Pain localized below the neck and above the inferior gluteal folds.&#xD;
&#xD;
          -  Body mass index ranging between 18 and 35 kg/m².&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unwillingness to stop taking pain or antispasmodic medication other than the study&#xD;
             medication (specifically opioid use [e.g., Vicodin], barbiturates, and cannabis).&#xD;
&#xD;
          -  Chronic pain for the previous 3 months or longer, on more days than not.&#xD;
&#xD;
          -  Radicular pain in the lower extremity (i.e. pain radiating below the knee), sciatica&#xD;
             pain down the leg, or pain below the knee (indicating a lumber radiculopathy);&#xD;
             radicular pain in the upper extremity, radiating into the forearm or hand (indicating&#xD;
             a cervical radiculopathy).&#xD;
&#xD;
          -  Concomitant severe pain in a region other than the back.&#xD;
&#xD;
          -  Spinal surgery within 1 year of study entry.&#xD;
&#xD;
          -  Back pain due to major trauma (e.g., motor vehicle accident, fracture of bone) unless&#xD;
             resolved for more than 1 year.&#xD;
&#xD;
          -  Treatment of back pain ongoing with non-pharmacological therapy (e.g., acupuncture,&#xD;
             chiropractic adjustment, massage, Transcutaneous Electrical Nerve Stimulation [TENS],&#xD;
             physiotherapy).&#xD;
&#xD;
          -  Subjects who test positive for alcohol by breathalyzer test.&#xD;
&#xD;
          -  Unwilling to stop taking moderate to potent inhibitors of cytochrome P450 (CYP)&#xD;
             isozymes CYP2D6 and CYP2C19, which are likely to cause drug interactions with&#xD;
             tolperisone HCl (e.g., medications such as paroxetine and fluvoxamine).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tennessee Valley Pain Consultants</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fiel Family and Sports Medicine</name>
      <address>
        <city>Tempe</city>
        <state>Arizona</state>
        <zip>85283</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center of Applied Research</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center of Fresno</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Long Beach Clinical Trials Services, Inc.</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern California Research</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95628</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Research Network, LLC</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Diego Sports Medicine</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CITrials</name>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riverside Clinical Research</name>
      <address>
        <city>Edgewater</city>
        <state>Florida</state>
        <zip>32132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Empirical Research Group</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32653</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Savin Medical Group</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LLC Medical Research</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Avail Clinical Research</name>
      <address>
        <city>Orange City</city>
        <state>Florida</state>
        <zip>32763</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private Practice</name>
      <address>
        <city>Plantation</city>
        <state>Florida</state>
        <zip>33313</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NeuroTrials Research, Inc.</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgia Institute for Clinical Research</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgia Clinical Research</name>
      <address>
        <city>Snellville</city>
        <state>Georgia</state>
        <zip>30078</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MediSphere Medical Research Center</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47714</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Otrimed Clinical Research</name>
      <address>
        <city>Edgewood</city>
        <state>Kentucky</state>
        <zip>41017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centex Studies, Inc.</name>
      <address>
        <city>Lake Charles</city>
        <state>Louisiana</state>
        <zip>70601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Rheumatology and Bone</name>
      <address>
        <city>Wheaton</city>
        <state>Maryland</state>
        <zip>20902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan Head Pain and Neurological</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sundance Clinical Research</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jubilee Clinical Research</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albuquerque Clinical Trials, Inc.</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Upstate Clinical Research Associates</name>
      <address>
        <city>Williamsville</city>
        <state>New York</state>
        <zip>14221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of America</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sterling Research Group- Springdale</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Providence Health Partners</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45439</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IPS Research</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Williamette Valley Clinical Studies</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Frontier Clinical Research, Inc.</name>
      <address>
        <city>Smithfield</city>
        <state>Pennsylvania</state>
        <zip>15478</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omega Medical Research</name>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <zip>02886</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Concepts</name>
      <address>
        <city>Rapid City</city>
        <state>South Dakota</state>
        <zip>57702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inquest Clinical Research</name>
      <address>
        <city>Baytown</city>
        <state>Texas</state>
        <zip>77521</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DiscoveResearch, Inc.</name>
      <address>
        <city>Bryan</city>
        <state>Texas</state>
        <zip>77802</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HD Research Corp</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centex Studies, Inc.</name>
      <address>
        <city>McAllen</city>
        <state>Texas</state>
        <zip>78504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ClinRX Research Joseph, Inc.</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Highland Clinical Research</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Research of Hampton Roads, Inc.</name>
      <address>
        <city>Newport News</city>
        <state>Virginia</state>
        <zip>23606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <results_first_submitted>October 19, 2020</results_first_submitted>
  <results_first_submitted_qc>October 19, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">November 10, 2020</results_first_posted>
  <last_update_submitted>January 28, 2022</last_update_submitted>
  <last_update_submitted_qc>January 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Cramp</mesh_term>
    <mesh_term>Spasm</mesh_term>
    <mesh_term>Hyperkinesis</mesh_term>
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
    <mesh_term>Acute Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tolperisone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 2, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT03802565/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 6, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT03802565/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Tolperisone 50 mg</title>
          <description>TID (150 mg/day)&#xD;
Tolperisone: TID</description>
        </group>
        <group group_id="P2">
          <title>Tolperisone 100 mg</title>
          <description>TID (300 mg/day)&#xD;
Tolperisone: TID</description>
        </group>
        <group group_id="P3">
          <title>Tolperisone 150 mg</title>
          <description>TID (450 mg/day)&#xD;
Tolperisone: TID</description>
        </group>
        <group group_id="P4">
          <title>Tolperisone 200 mg</title>
          <description>TID (600 mg/day)&#xD;
Tolperisone: TID</description>
        </group>
        <group group_id="P5">
          <title>Placebo</title>
          <description>TID&#xD;
Placebo: Placebo</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="82"/>
                <participants group_id="P2" count="87"/>
                <participants group_id="P3" count="83"/>
                <participants group_id="P4" count="85"/>
                <participants group_id="P5" count="78"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="77"/>
                <participants group_id="P2" count="83"/>
                <participants group_id="P3" count="74"/>
                <participants group_id="P4" count="77"/>
                <participants group_id="P5" count="72"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subjects Related to Each Other</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Elevated Enzymes</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Tolperisone 50 mg</title>
          <description>TID (150 mg/day)&#xD;
Tolperisone: TID</description>
        </group>
        <group group_id="B2">
          <title>Tolperisone 100 mg</title>
          <description>TID (300 mg/day)&#xD;
Tolperisone: TID</description>
        </group>
        <group group_id="B3">
          <title>Tolperisone 150 mg</title>
          <description>TID (450 mg/day)&#xD;
Tolperisone: TID</description>
        </group>
        <group group_id="B4">
          <title>Tolperisone 200 mg</title>
          <description>TID (600 mg/day)&#xD;
Tolperisone: TID</description>
        </group>
        <group group_id="B5">
          <title>Placebo</title>
          <description>TID&#xD;
Placebo: Placebo</description>
        </group>
        <group group_id="B6">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="82"/>
            <count group_id="B2" value="87"/>
            <count group_id="B3" value="83"/>
            <count group_id="B4" value="85"/>
            <count group_id="B5" value="78"/>
            <count group_id="B6" value="415"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43.5" lower_limit="20" upper_limit="65"/>
                    <measurement group_id="B2" value="44.4" lower_limit="19" upper_limit="65"/>
                    <measurement group_id="B3" value="44.3" lower_limit="21" upper_limit="65"/>
                    <measurement group_id="B4" value="42.0" lower_limit="20" upper_limit="64"/>
                    <measurement group_id="B5" value="41.6" lower_limit="18" upper_limit="62"/>
                    <measurement group_id="B6" value="43.6" lower_limit="18" upper_limit="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="41"/>
                    <measurement group_id="B4" value="41"/>
                    <measurement group_id="B5" value="49"/>
                    <measurement group_id="B6" value="233"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="42"/>
                    <measurement group_id="B4" value="44"/>
                    <measurement group_id="B5" value="29"/>
                    <measurement group_id="B6" value="182"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="20"/>
                    <measurement group_id="B5" value="16"/>
                    <measurement group_id="B6" value="89"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="69"/>
                    <measurement group_id="B3" value="61"/>
                    <measurement group_id="B4" value="65"/>
                    <measurement group_id="B5" value="62"/>
                    <measurement group_id="B6" value="326"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="29"/>
                    <measurement group_id="B4" value="35"/>
                    <measurement group_id="B5" value="29"/>
                    <measurement group_id="B6" value="154"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="49"/>
                    <measurement group_id="B4" value="45"/>
                    <measurement group_id="B5" value="42"/>
                    <measurement group_id="B6" value="236"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>kilogram/meter^2</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.23" lower_limit="19.4" upper_limit="35.0"/>
                    <measurement group_id="B2" value="28.48" lower_limit="20.9" upper_limit="35.0"/>
                    <measurement group_id="B3" value="28.34" lower_limit="19.8" upper_limit="35.0"/>
                    <measurement group_id="B4" value="28.45" lower_limit="20.0" upper_limit="35.0"/>
                    <measurement group_id="B5" value="28.53" lower_limit="19.5" upper_limit="35.0"/>
                    <measurement group_id="B6" value="28.38" lower_limit="19.4" upper_limit="35.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Effect Size in Subjected-Rated Pain</title>
        <description>Mean effect size between Tolperisone and Placebo of subject-rated pain due to acute back spasm using a Numerical Rating Scale (NRS; 0-10 scale, from no pain to worst possible pain) on Day 14 &quot;right now.&quot;</description>
        <time_frame>Day 1 to Day 14</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tolperisone 50 mg</title>
            <description>TID (150 mg/day)&#xD;
Tolperisone: TID</description>
          </group>
          <group group_id="O2">
            <title>Tolperisone 100 mg</title>
            <description>TID (300 mg/day)&#xD;
Tolperisone: TID</description>
          </group>
          <group group_id="O3">
            <title>Tolperisone 150 mg</title>
            <description>TID (450 mg/day)&#xD;
Tolperisone: TID</description>
          </group>
          <group group_id="O4">
            <title>Tolperisone 200 mg</title>
            <description>TID (600 mg/day)&#xD;
Tolperisone: TID</description>
          </group>
          <group group_id="O5">
            <title>Placebo</title>
            <description>TID&#xD;
Placebo: Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Effect Size in Subjected-Rated Pain</title>
          <description>Mean effect size between Tolperisone and Placebo of subject-rated pain due to acute back spasm using a Numerical Rating Scale (NRS; 0-10 scale, from no pain to worst possible pain) on Day 14 &quot;right now.&quot;</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="87"/>
                <count group_id="O3" value="83"/>
                <count group_id="O4" value="85"/>
                <count group_id="O5" value="78"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.2" lower_limit="-9" upper_limit="1"/>
                    <measurement group_id="O2" value="-4.0" lower_limit="-10" upper_limit="2"/>
                    <measurement group_id="O3" value="-3.7" lower_limit="-8" upper_limit="1"/>
                    <measurement group_id="O4" value="-4.4" lower_limit="-10" upper_limit="1"/>
                    <measurement group_id="O5" value="-3.5" lower_limit="-8" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>First Dose, Day 1 to Follow-up, Day 28</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Tolperisone 50 mg</title>
          <description>TID (150 mg/day)&#xD;
Tolperisone: TID</description>
        </group>
        <group group_id="E2">
          <title>Tolperisone 100 mg</title>
          <description>TID (300 mg/day)&#xD;
Tolperisone: TID</description>
        </group>
        <group group_id="E3">
          <title>Tolperisone 150 mg</title>
          <description>TID (450 mg/day)&#xD;
Tolperisone: TID</description>
        </group>
        <group group_id="E4">
          <title>Tolperisone 200 mg</title>
          <description>TID (600 mg/day)&#xD;
Tolperisone: TID</description>
        </group>
        <group group_id="E5">
          <title>Placebo</title>
          <description>TID&#xD;
Placebo: Placebo</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="14" subjects_at_risk="85"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="85"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="85"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="87"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Randall Kaye, MD - Chief Medical Officer</name_or_title>
      <organization>Neurana Pharmaceuticals, Inc.</organization>
      <phone>858-732-0708</phone>
      <email>rkaye@neuranapharma.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03802565
org study id: 201
nct id: NCT03802565
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a double-blind, randomized, placebo-controlled, parallel group study of the efficacy
      and safety of tolperisone (a non-opioid) or placebo administered as multiple doses three
      times a day (TID) in approximately 400 male and female subjects experiencing back pain due to
      or associated with muscle spasm.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Mean Effect Size in Subjected-Rated Pain
time frame: Day 1 to Day 14
description: Mean effect size between Tolperisone and Placebo of subject-rated pain due to acute back spasm using a Numerical Rating Scale (NRS; 0-10 scale, from no pain to worst possible pain) on Day 14 "right now."
arm group label: Tolperisone 50 mg
arm group type: Experimental
description: TID (150 mg/day)
arm group label: Tolperisone 100 mg
arm group type: Experimental
description: TID (300 mg/day)
arm group label: Tolperisone 150 mg
arm group type: Experimental
description: TID (450 mg/day)
arm group label: Tolperisone 200 mg
arm group type: Experimental
description: TID (600 mg/day)
arm group label: Placebo
arm group type: Placebo Comparator
description: TID
intervention type: Drug
intervention name: Tolperisone
description: TID
arm group label: Tolperisone 100 mg
arm group label: Tolperisone 150 mg
arm group label: Tolperisone 200 mg
arm group label: Tolperisone 50 mg
intervention type: Drug
intervention name: Placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
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country: United States
responsible party type: Sponsor
mesh term: Muscle Cramp
mesh term: Spasm
mesh term: Hyperkinesis
mesh term: Back Pain
mesh term: Low Back Pain
mesh term: Acute Pain
mesh term: Tolperisone
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 