<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/NCT03290131</url>
  </required_header>
  <id_info>
    <org_study_id>OS440-3004</org_study_id>
    <nct_id>NCT03290131</nct_id>
  </id_info>
  <brief_title>A Study to Investigate the Safety and Effectiveness of Arbaclofen Extended-Release Tablets for Patients With MS</brief_title>
  <acronym>OS440-3004</acronym>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Efficacy of Arbaclofen Extended-Release Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RVL Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Osmotica Pharmaceutical US LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>RVL Pharmaceuticals, Inc.</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>
      Multiple Sclerosis (MS) is an acquired inflammatory demyelinating disease of the central&#xD;
      nervous system (CNS) that is regarded as the foremost cause of non-traumatic neurologic&#xD;
      disability in adults in North America. Spasticity is a common complication in MS and occurs&#xD;
      in up to 84% of patients. The main sign of spasticity is resistance to passive limb movement&#xD;
      characterized by increased resistance to stretching, clonus, and exaggerated deep reflexes.&#xD;
      Osmotica Pharmaceutical is currently developing arbaclofen extended-release tablets (AERT)&#xD;
      for the treatment of spasticity in patients with MS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to&#xD;
      evaluate the safety and efficacy of oral AERT in MS patients with spasticity. Two doses of&#xD;
      AERT, 40 mg and 80 mg, will be compared with placebo. The treatment groups will be randomized&#xD;
      in a 1:1:1 ratio. Eligible patients will undergo a washout period for withdrawal of all&#xD;
      medications used for anti-spasticity and/or muscle relaxation prior to randomization. A&#xD;
      baseline clinical evaluation will be performed (Visit 2) to confirm eligibility for study&#xD;
      randomization, and subjects will be randomly assigned to 1 of 3 treatment arms. Subjects will&#xD;
      remain on maintenance treatment for approximately 3 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 28, 2018</start_date>
  <completion_date type="Actual">January 2, 2019</completion_date>
  <primary_completion_date type="Actual">December 3, 2018</primary_completion_date>
  <phase>Phase 3</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Total Numeric-transformed Modified Ashworth Scale Score of the Most Affected Limb (TNmAS-MAL)</measure>
    <time_frame>84 days</time_frame>
    <description>Total Numeric-Transformed Modified Ashworth Scale (TNmAS) is a 6-point scale to measure abnormality in tone or the resistance to passive movements. Higher score is worse outcome.&#xD;
For each joint, the minimum score is 0; maximum score is 5. The values for each of the 3 main joints are summed for the limb score. The limb with the highest score is the most affected limb (MAL). The highest possible score for a limb is 15. Limb range: 0 to 15.&#xD;
To arrive at total limbs (TL) score the values for all 4 limbs are summed; maximum total limb score is 60. TL range: 0 to 60.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Global Impression of Change (CGIC)</measure>
    <time_frame>84 days</time_frame>
    <description>The Clinical Global Impression of Change (CGIC) was developed to provide a brief, stand-alone assessment of the clinician's view of the subject's global functioning prior to and after initiating a study medication. The scale ranges from -3 to +3 judging whether the change is significantly worse (-3) to significantly improved (+3). Higher score is better outcome. The CGIC scale will be used to measure the overall change in the subject's condition since starting the study. There is no baseline value because the score is a measure of how the patient changed from baseline (treatment initiation).</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">536</enrollment>
  <condition>Multiple Sclerosis</condition>
  <condition>Spasticity, Muscle</condition>
  <arm_group>
    <arm_group_label>AERT 40 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>40 mg Arbaclofen Extended-Release Tablets</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AERT 80 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>80 mg Arbaclofen Extended-Release Tablets</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Arbaclofen</intervention_name>
    <description>Arbaclofen Extended Release Tablet</description>
    <arm_group_label>AERT 40 mg</arm_group_label>
    <arm_group_label>AERT 80 mg</arm_group_label>
    <other_name>AERT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo comparator</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria Includes:&#xD;
&#xD;
          -  Subjects 18 to 65 years of age, inclusive.&#xD;
&#xD;
          -  An established diagnosis of MS that manifests a documented history of spasticity.&#xD;
&#xD;
          -  If receiving disease-modifying medications (eg, interferons approved for MS,&#xD;
             glatiramer acetate, natalizumab, fingolimod, or mitoxantrone), there must be no change&#xD;
             in dose for at least 3 months prior to Visit 1 (Screening), and the subject must be&#xD;
             willing to maintain this treatment dose for the duration of the study. If receiving&#xD;
             AMPYRA® (dalfampridine, fampridine, 4-amino puridine), subject must be at a stable&#xD;
             dose for at least 3 months prior to Visit 1.&#xD;
&#xD;
          -  Stable regimen for at least 3 months prior to Visit 2 for all medications and&#xD;
             non-pharmacological therapies that are intended to alleviate spasticity.&#xD;
&#xD;
          -  Absence of infections, peripheral vascular disease, painful contractures, advanced&#xD;
             arthritis, or other conditions that hinder evaluation of joint movement.&#xD;
&#xD;
          -  Use of a medically highly effective form of birth control (see Section 7.8) during the&#xD;
             study and for 3 months thereafter for women of child-bearing potential (including&#xD;
             female subjects and female partners of non-sterile male subjects).&#xD;
&#xD;
          -  Willing to sign the informed consent form (ICF).&#xD;
&#xD;
        Exclusion Criteria Includes:&#xD;
&#xD;
          -  Any concomitant disease or disorder that has symptoms of spasticity or that may&#xD;
             influence the subject's level of spasticity.&#xD;
&#xD;
          -  Concomitant use of medications that would potentially interfere with the actions of&#xD;
             the study medication or outcome variables.&#xD;
&#xD;
          -  Pregnancy, lactation, or planned pregnancy during the course of the study and for 3&#xD;
             months after the final study visit.&#xD;
&#xD;
          -  Subject has clinically significant abnormal laboratory values, in the opinion of the&#xD;
             investigator, at Visit 1 or Visit 2.&#xD;
&#xD;
          -  Current malignancy or history of malignancy that has not been in remission for more&#xD;
             than 5 years, except effectively treated basal cell skin carcinoma.&#xD;
&#xD;
          -  Any other significant disease, disorder, or significant laboratory finding which, in&#xD;
             the opinion of the investigator, puts the subject at risk because of participation,&#xD;
             influences the result of the study, or affects the subject's ability to participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Jacobs, MD</last_name>
    <role>Study Director</role>
    <affiliation>Vice President</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Grodno Regional Clinical Hospital</name>
      <address>
        <city>Grodno</city>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minsk City Clinical Hospital #5</name>
      <address>
        <city>Minsk</city>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minsk Scientific and Practical Center of Surgery, Transplantology and Hematology</name>
      <address>
        <city>Minsk</city>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Republican Research and Development Center for Neurology and Neurosurgery</name>
      <address>
        <city>Minsk</city>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitebsk Regional Diagnostic Center</name>
      <address>
        <city>Vitebsk</city>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Clinical Centre of the Republic of Srpska, Clinic of Neurology</name>
      <address>
        <city>Banja Luka</city>
        <country>Bosnia and Herzegovina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Clinical Hospital Mostar, Clinic of Neurology</name>
      <address>
        <city>Mostar</city>
        <country>Bosnia and Herzegovina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multiprofile Hospital for Active Treatment - Pleven within the structure of Military Medical Academy, Sofia</name>
      <address>
        <city>Pleven</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Multiprofile Hospital for Active Treatment &quot;Dr. Georgi Stranski&quot;, Pleven, Clinic of Neurological Diseases</name>
      <address>
        <city>Pleven</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center &quot;Rusemed&quot; EOOD</name>
      <address>
        <city>Ruse</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multiprofile Hospital for Active Treatment &quot;ACIBADEM City Clinic Tokuda Hospital&quot;, Sofia, Neurology and Sleep Medicine Clinic</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multiprofile Hospital for Active Treatment of Neurology and Psychiatry &quot;Sveti Naum&quot;, Sofia</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Multiprofile Hospital for Active Treatment &quot;Sveti Ivan Rilski&quot;, Sofia, Clinic of Neurology Diseases</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Hospital Center Osijek, Clinic of Neurology</name>
      <address>
        <city>Osijek</city>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Hospital Center Rijeka, Department of Neurology</name>
      <address>
        <city>Rijeka</city>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital Varazdin, Department of Neurology</name>
      <address>
        <city>Varaždin</city>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Hospital Dubrava, Department of Neurology</name>
      <address>
        <city>Zagreb</city>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute for Emergency Medicine</name>
      <address>
        <city>Chisinau</city>
        <country>Moldova, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Institute of Neurology and Neurosurgery</name>
      <address>
        <city>Chisinau</city>
        <country>Moldova, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dendryt Medical Center</name>
      <address>
        <city>Katowice</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neuro-Medic</name>
      <address>
        <city>Katowice</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Practice Professor K. Rejdak</name>
      <address>
        <city>Lublin</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MED-Polonia, Sp. z o.o. (LLC)</name>
      <address>
        <city>Poznań</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;MEDYK&quot; Stanislaw Mazur Sp. z o.o. (LLC) Medical Centre</name>
      <address>
        <city>Rzeszów</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NeuroProtect Medical Center</name>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurology Center Krzysztof Selmaj</name>
      <address>
        <city>Łódź</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Center of Serbia</name>
      <address>
        <city>Belgrade</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Hospital Center Zemun, Department of Neurology</name>
      <address>
        <city>Belgrade</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Hospital Center Zvezdara</name>
      <address>
        <city>Belgrade</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Center Kragujevac</name>
      <address>
        <city>Kragujevac</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belarus</country>
    <country>Bosnia and Herzegovina</country>
    <country>Bulgaria</country>
    <country>Croatia</country>
    <country>Moldova, Republic of</country>
    <country>Poland</country>
    <country>Serbia</country>
  </location_countries>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <results_first_submitted>June 16, 2022</results_first_submitted>
  <results_first_submitted_qc>July 12, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">July 15, 2022</results_first_posted>
  <disposition_first_submitted>August 28, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>July 12, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">July 15, 2022</disposition_first_posted>
  <last_update_submitted>July 12, 2022</last_update_submitted>
  <last_update_submitted_qc>July 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 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 Spasticity</mesh_term>
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <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>November 9, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT03290131/Prot_000.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>January 28, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT03290131/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>AERT 40 mg</title>
          <description>40 mg//day Arbaclofen Extended-Release Tablets</description>
        </group>
        <group group_id="P2">
          <title>AERT 80 mg</title>
          <description>80 mg/day Arbaclofen Extended-Release Tablets</description>
        </group>
        <group group_id="P3">
          <title>Placebo</title>
          <description>Placebo Tablets</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="179"/>
                <participants group_id="P2" count="179"/>
                <participants group_id="P3" count="178"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="137"/>
                <participants group_id="P2" count="107"/>
                <participants group_id="P3" count="159"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="72"/>
                <participants group_id="P3" count="19"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="57"/>
                <participants group_id="P3" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>MS Relapse</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unknown reason</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>AERT 40 mg</title>
          <description>40 mg/day Arbaclofen Extended-Release Tablets</description>
        </group>
        <group group_id="B2">
          <title>AERT 80 mg</title>
          <description>80 mg/day Arbaclofen Extended-Release Tablets</description>
        </group>
        <group group_id="B3">
          <title>Placebo</title>
          <description>Placebo Tablets</description>
        </group>
        <group group_id="B4">
          <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="179"/>
            <count group_id="B2" value="179"/>
            <count group_id="B3" value="178"/>
            <count group_id="B4" value="536"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="179"/>
                    <measurement group_id="B2" value="179"/>
                    <measurement group_id="B3" value="178"/>
                    <measurement group_id="B4" value="536"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</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_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="108"/>
                    <measurement group_id="B2" value="101"/>
                    <measurement group_id="B3" value="110"/>
                    <measurement group_id="B4" value="319"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="78"/>
                    <measurement group_id="B3" value="68"/>
                    <measurement group_id="B4" value="217"/>
                  </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="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="169"/>
                    <measurement group_id="B2" value="172"/>
                    <measurement group_id="B3" value="171"/>
                    <measurement group_id="B4" value="512"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="21"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</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="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</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_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="171"/>
                    <measurement group_id="B2" value="177"/>
                    <measurement group_id="B3" value="174"/>
                    <measurement group_id="B4" value="522"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total Numeric-Transformed Modified Ashworth Scale (Most Affected Limb)</title>
          <description>Total Numeric-Transformed Modified Ashworth Scale (TNmAS) is a 6-point scale to measure abnormality in tone or the resistance to passive movements. Higher score is worse outcome.&#xD;
For each joint, the minimum score is 0; maximum score is 5. The values for each of the 3 main joints are summed for the limb score. The limb with the highest score is the most affected limb (MAL). The highest possible score for a limb is 15. Limb range: 0 to 15.&#xD;
To arrive at total limbs (TL) score the values for all 4 limbs are summed; maximum total limb score is 60. TL range: 0 to 60.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.4" spread="3.24"/>
                    <measurement group_id="B2" value="7.6" spread="3.02"/>
                    <measurement group_id="B3" value="7.6" spread="3.13"/>
                    <measurement group_id="B4" value="7.5" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Total Numeric-transformed Modified Ashworth Scale Score of the Most Affected Limb (TNmAS-MAL)</title>
        <description>Total Numeric-Transformed Modified Ashworth Scale (TNmAS) is a 6-point scale to measure abnormality in tone or the resistance to passive movements. Higher score is worse outcome.&#xD;
For each joint, the minimum score is 0; maximum score is 5. The values for each of the 3 main joints are summed for the limb score. The limb with the highest score is the most affected limb (MAL). The highest possible score for a limb is 15. Limb range: 0 to 15.&#xD;
To arrive at total limbs (TL) score the values for all 4 limbs are summed; maximum total limb score is 60. TL range: 0 to 60.</description>
        <time_frame>84 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AERT 40 mg</title>
            <description>40 mg/day Arbaclofen Extended-Release Tablets</description>
          </group>
          <group group_id="O2">
            <title>AERT 80 mg</title>
            <description>80 mg/day Arbaclofen Extended-Release Tablets</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo Tablets</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Numeric-transformed Modified Ashworth Scale Score of the Most Affected Limb (TNmAS-MAL)</title>
          <description>Total Numeric-Transformed Modified Ashworth Scale (TNmAS) is a 6-point scale to measure abnormality in tone or the resistance to passive movements. Higher score is worse outcome.&#xD;
For each joint, the minimum score is 0; maximum score is 5. The values for each of the 3 main joints are summed for the limb score. The limb with the highest score is the most affected limb (MAL). The highest possible score for a limb is 15. Limb range: 0 to 15.&#xD;
To arrive at total limbs (TL) score the values for all 4 limbs are summed; maximum total limb score is 60. TL range: 0 to 60.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="179"/>
                <count group_id="O2" value="179"/>
                <count group_id="O3" value="178"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.7" spread="1.97"/>
                    <measurement group_id="O2" value="-2.0" spread="1.78"/>
                    <measurement group_id="O3" value="-1.4" spread="1.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Clinical Global Impression of Change (CGIC)</title>
        <description>The Clinical Global Impression of Change (CGIC) was developed to provide a brief, stand-alone assessment of the clinician's view of the subject's global functioning prior to and after initiating a study medication. The scale ranges from -3 to +3 judging whether the change is significantly worse (-3) to significantly improved (+3). Higher score is better outcome. The CGIC scale will be used to measure the overall change in the subject's condition since starting the study. There is no baseline value because the score is a measure of how the patient changed from baseline (treatment initiation).</description>
        <time_frame>84 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AERT 40 mg</title>
            <description>40 mg/day Arbaclofen Extended-Release Tablets</description>
          </group>
          <group group_id="O2">
            <title>AERT 80 mg</title>
            <description>80 mg/day Arbaclofen Extended-Release Tablets</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo Tablets&#xD;
P</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Global Impression of Change (CGIC)</title>
          <description>The Clinical Global Impression of Change (CGIC) was developed to provide a brief, stand-alone assessment of the clinician's view of the subject's global functioning prior to and after initiating a study medication. The scale ranges from -3 to +3 judging whether the change is significantly worse (-3) to significantly improved (+3). Higher score is better outcome. The CGIC scale will be used to measure the overall change in the subject's condition since starting the study. There is no baseline value because the score is a measure of how the patient changed from baseline (treatment initiation).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="179"/>
                <count group_id="O2" value="179"/>
                <count group_id="O3" value="178"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="1.0"/>
                    <measurement group_id="O2" value="0.4" spread="1.23"/>
                    <measurement group_id="O3" value="0.6" spread="0.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data collected over 92 day period.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>AERT 40 mg</title>
          <description>40 mg/day Arbaclofen Extended-Release Tablets</description>
        </group>
        <group group_id="E2">
          <title>AERT 80 mg</title>
          <description>80 mg/day Arbaclofen Extended-Release Tablets</description>
        </group>
        <group group_id="E3">
          <title>Placebo</title>
          <description>Placebo Tablets</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (20.1)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <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="179"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Withdrawal Syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Hip Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Joint Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Schwannoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Multiple Sclerosis Relapse</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="179"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="179"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Restless Leg Syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Status Epilepticus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Trigeminal Neuralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Depression Suicidal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Somatic Symptom Disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Toxic Skin Eruption</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (20.1)</default_vocab>
        <default_assessment>Non-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="148" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="154" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="133" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="179"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="179"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="40" subjects_affected="40" subjects_at_risk="179"/>
                <counts group_id="E2" events="30" subjects_affected="30" subjects_at_risk="179"/>
                <counts group_id="E3" events="28" subjects_affected="28" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="179"/>
                <counts group_id="E2" events="19" subjects_affected="19" subjects_at_risk="179"/>
                <counts group_id="E3" events="16" subjects_affected="16" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="24" subjects_affected="24" subjects_at_risk="179"/>
                <counts group_id="E2" events="37" subjects_affected="37" subjects_at_risk="179"/>
                <counts group_id="E3" events="27" subjects_affected="27" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Gait Disturbance</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="179"/>
                <counts group_id="E2" events="14" subjects_affected="14" subjects_at_risk="179"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="179"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="179"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscular Weakness</sub_title>
                <counts group_id="E1" events="43" subjects_affected="43" subjects_at_risk="179"/>
                <counts group_id="E2" events="40" subjects_affected="40" subjects_at_risk="179"/>
                <counts group_id="E3" events="27" subjects_affected="27" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="27" subjects_affected="27" subjects_at_risk="179"/>
                <counts group_id="E2" events="35" subjects_affected="35" subjects_at_risk="179"/>
                <counts group_id="E3" events="20" subjects_affected="20" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="20" subjects_affected="20" subjects_at_risk="179"/>
                <counts group_id="E2" events="27" subjects_affected="27" subjects_at_risk="179"/>
                <counts group_id="E3" events="19" subjects_affected="19" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="179"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="179"/>
                <counts group_id="E3" events="12" subjects_affected="12" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary Tract Disorder</sub_title>
                <counts group_id="E1" events="56" subjects_affected="56" subjects_at_risk="179"/>
                <counts group_id="E2" events="57" subjects_affected="57" subjects_at_risk="179"/>
                <counts group_id="E3" events="67" subjects_affected="67" subjects_at_risk="178"/>
              </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>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Vice President, Regulatory Affairs and Quality</name_or_title>
      <organization>RVL Pharmaceuticals, Inc.</organization>
      <phone>908-809-1300</phone>
      <email>Regulatory@RVLpharma.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/NCT03290131
org study id: OS440-3004
nct id: NCT03290131
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Multiple Sclerosis (MS) is an acquired inflammatory demyelinating disease of the central
      nervous system (CNS) that is regarded as the foremost cause of non-traumatic neurologic
      disability in adults in North America. Spasticity is a common complication in MS and occurs
      in up to 84% of patients. The main sign of spasticity is resistance to passive limb movement
      characterized by increased resistance to stretching, clonus, and exaggerated deep reflexes.
      Osmotica Pharmaceutical is currently developing arbaclofen extended-release tablets (AERT)
      for the treatment of spasticity in patients with MS.
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to
      evaluate the safety and efficacy of oral AERT in MS patients with spasticity. Two doses of
      AERT, 40 mg and 80 mg, will be compared with placebo. The treatment groups will be randomized
      in a 1:1:1 ratio. Eligible patients will undergo a washout period for withdrawal of all
      medications used for anti-spasticity and/or muscle relaxation prior to randomization. A
      baseline clinical evaluation will be performed (Visit 2) to confirm eligibility for study
      randomization, and subjects will be randomly assigned to 1 of 3 treatment arms. Subjects will
      remain on maintenance treatment for approximately 3 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change From Baseline in Total Numeric-transformed Modified Ashworth Scale Score of the Most Affected Limb (TNmAS-MAL)
time frame: 84 days
description: Total Numeric-Transformed Modified Ashworth Scale (TNmAS) is a 6-point scale to measure abnormality in tone or the resistance to passive movements. Higher score is worse outcome.
For each joint, the minimum score is 0; maximum score is 5. The values for each of the 3 main joints are summed for the limb score. The limb with the highest score is the most affected limb (MAL). The highest possible score for a limb is 15. Limb range: 0 to 15.
To arrive at total limbs (TL) score the values for all 4 limbs are summed; maximum total limb score is 60. TL range: 0 to 60.
measure: Clinical Global Impression of Change (CGIC)
time frame: 84 days
description: The Clinical Global Impression of Change (CGIC) was developed to provide a brief, stand-alone assessment of the clinician's view of the subject's global functioning prior to and after initiating a study medication. The scale ranges from -3 to +3 judging whether the change is significantly worse (-3) to significantly improved (+3). Higher score is better outcome. The CGIC scale will be used to measure the overall change in the subject's condition since starting the study. There is no baseline value because the score is a measure of how the patient changed from baseline (treatment initiation).
arm group label: AERT 40 mg
arm group type: Active Comparator
description: 40 mg Arbaclofen Extended-Release Tablets
arm group label: AERT 80 mg
arm group type: Active Comparator
description: 80 mg Arbaclofen Extended-Release Tablets
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Drug
intervention name: Arbaclofen
description: Arbaclofen Extended Release Tablet
arm group label: AERT 40 mg
arm group label: AERT 80 mg
other name: AERT
intervention type: Drug
intervention name: Placebo
description: Placebo comparator
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: David Jacobs, MD
role: Study Director
affiliation: Vice President
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country: Belarus
country: Bosnia and Herzegovina
country: Bulgaria
country: Croatia
country: Moldova, Republic of
country: Poland
country: Serbia
country: United States
responsible party type: Sponsor
mesh term: Muscle Spasticity
mesh term: Multiple Sclerosis
mesh term: Sclerosis
provided document: 
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