<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/NCT03756974</url>
  </required_header>
  <id_info>
    <org_study_id>DroSpas-1</org_study_id>
    <nct_id>NCT03756974</nct_id>
  </id_info>
  <brief_title>BX-1 in Spasticity Due to Multiple Sclerosis</brief_title>
  <official_title>A Phase III, Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Investigate the Efficacy and Safety of BX-1 for the Symptomatic Relief of Spasticity in Patients With Multiple Sclerosis (MS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bionorica SE</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bionorica SE</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the efficacy and safety of orally administered BX-1 compared to placebo in&#xD;
      patients with spasticity due to multiple sclerosis not sufficiently controlled by current&#xD;
      anti-spasticity medication&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the present phase III clinical trial is to demonstrate superiority of BX-1, an&#xD;
      oral solution containing dronabinol, over placebo in patients with spasticity due to MS not&#xD;
      sufficiently controlled by their current anti-spasticity medication.&#xD;
&#xD;
      The trial is designed to show that BX-1 is able to reduce spasticity in MS patients not&#xD;
      showing sufficient response to their current anti-spasticity treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 18, 2019</start_date>
  <completion_date type="Actual">March 30, 2021</completion_date>
  <primary_completion_date type="Actual">March 30, 2021</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Responder analysis: proportion of patients showing improvement in spasticity of 18% or more in average Numerical Rating Scale for Spasticity (NRS-S) assessment at end of treatment</measure>
    <time_frame>16 weeks</time_frame>
    <description>Responder analysis: proportion of patients showing improvement in spasticity (change from baseline corresponding to the mean NRS-S score during 7 days prior to randomisation) of 18% or more in average NRS-S assessment at end of treatment (mean NRS-S score during 7 days prior to Visit 6).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Responder analysis: proportion of patients showing improvement in spasticity (change from baseline) of 30% or more in average NRS-S assessment at end of treatment (Visit 6)</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Responder analysis: proportion of patients showing improvement in spasticity (change from baseline) of 50% or more in average NRS-S assessment at end of treatment (Visit 6)</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to response: time to reach first improvement in spasticity (change from baseline) of 18% or more, based on patient's daily spasticity assessment on the NRS-S</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to response: time to reach first improvement in spasticity (change from baseline) of 30% or more, based on patient's daily spasticity assessment on the NRS-S</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weekly mean of the patient's daily spasticity assessments on the NRS-S during Visit 0 - Visit 6</measure>
    <time_frame>21 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weekly mean of the patient's daily pain assessments on the Numerical Rating Scale for Pain (NRS-P) during Visit 0 - Visit 6</measure>
    <time_frame>21 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Responder analysis: proportion of patients showing improvement in pain (change from baseline) of 15% or more in average NRS-P assessment at end of treatment (Visit 6)</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Responder analysis: proportion of patients showing improvement in pain (change from baseline) of 30% or more in average NRS-P assessment at end of treatment (Visit 6)</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to response: time to reach first improvement in pain (change from baseline) of 15% or more, based on patient's pain assessment on the NRS-P</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to response: time to reach first improvement in pain (change from baseline) of 30% or more, based on patient's pain assessment on the NRS-P</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weekly mean of the patient's daily spasm frequency and severity assessments on the Penn Spasm Frequency Scale (PSFS) during Visit 0 - Visit 6</measure>
    <time_frame>21 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline of spasm frequency and severity assessments on the PSFS at end of treatment (Visit 6)</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline of Timed 25-Foot Walk (T25-FW) at Visit 4 and Visit 6</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Responder analysis: proportion of patients showing improvement in TF25-FW (change from baseline) of 20% or more at Visit 6</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline of the physical and psychological impact of multiple sclerosis assessed with the Multiple Sclerosis Impact Scale- 29 version 2 (MSIS-29 v2) at Visit 4 and Visit 6</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline of quality of life measured with Short-Form Health Survey of the Medical Outcomes Study Version 2 (SF-36 v2) at Visit 6</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline of sleep quality measured with the Numerical Rating Scale for Sleep Quality (NRS-SQ) at Visit 3 - Visit 6</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline of fatigue measured with the Numerical Rating Scale for Fatigue (NRS-F) at Visit 3 - Visit 6</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall patients' status measured by Patient´s Global Impression of Change scale (PGIC) at Visit 5 and Visit 6</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall patients' status measured by Clinical Global Impression - Improvement scale (CGI-I) at Visit 5 and Visit 6</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">397</enrollment>
  <condition>Spasticity Due to Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>BX-1 (dronabinol)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BX-1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo of BX-1</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BX-1</intervention_name>
    <description>BX-1 (dronabinol), oral solution. All patients enrolled establish their individually tolerable dose by dose Titration.</description>
    <arm_group_label>BX-1 (dronabinol)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo of BX-1, oral solution</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female patients aged 18 to 65 years&#xD;
&#xD;
          2. Presence of MS according to 2010 or 2017 revised McDonald criteria&#xD;
&#xD;
          3. Patients with stable MS for at least 3 months before enrolment in the opinion of the&#xD;
             treating physician Note: Patients with a MS relapse during 3 month prior to enrolment&#xD;
             are not considered to have stable MS&#xD;
&#xD;
          4. Ongoing spasticity for at least 3 months before enrolment&#xD;
&#xD;
          5. Spasticity in at least 2 lower limb muscles&#xD;
&#xD;
          6. Expanded Disability Status Scale (EDSS) score ≥ 3.0 and ≤ 6.5&#xD;
&#xD;
          7. Previous treatment with at least two different optimized oral MS anti-spasticity&#xD;
             therapies before inclusion. Both treatment attempts must include at least baclofen or&#xD;
             oral tizanidine, which can be combined with other anti-spasticity drugs.&#xD;
&#xD;
             AND Patients currently receiving an optimized treatment corresponding to the last&#xD;
             treatment attempt with stable dosage for at least 30 days prior to Visit 0.&#xD;
&#xD;
          8. Female patients of non-childbearing potential or if of childbearing potential using&#xD;
             highly effective contraceptive methods or double barrier contraception.&#xD;
&#xD;
             For men: no specific contraception methods need to be used.&#xD;
&#xD;
          9. Willingness to follow the study procedure for the whole duration of the trial and&#xD;
             signed informed consent at screening prior to any trial-related procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any present disease other than MS that could affect spasticity (e.g. traumatic brain&#xD;
             injury, spinal cord injury, brain damage due to a lack of oxygen, stroke,&#xD;
             encephalitis, meningitis)&#xD;
&#xD;
          2. Intake of not permitted concomitant medication prior to screening and concomitant&#xD;
             medication which should be unaltered prior to screening in an unstable dosage regimen&#xD;
&#xD;
          3. Significant fixed tendon contractures&#xD;
&#xD;
          4. History of epileptic seizures&#xD;
&#xD;
          5. History of or existing relevant CNS disorder (other than MS)&#xD;
&#xD;
          6. History of or existing relevant psychiatric disorders (e.g. schizophrenia, psychosis,&#xD;
             manic disorders, severe depressive disorders, suicidal ideations, drug and/or alcohol&#xD;
             abuse etc.)&#xD;
&#xD;
          7. Patients with a positive drug abuse screening test, except for medications used to&#xD;
             treat a medical condition and reported as such by the patient; all patients with a&#xD;
             positive result for cannabis/THC&#xD;
&#xD;
          8. History of or existing cardiac diseases or pathological findings (e.g. chronic&#xD;
             insufficiency NYHA III/IV, severe arrhythmia, unstable angina pectoris, myocardial&#xD;
             infarction within the past 6 months, QT prolongation)&#xD;
&#xD;
          9. Known HIV, and/or active Hepatitis B or C infection&#xD;
&#xD;
         10. History of or existing malignancy during the 5 years before screening except history&#xD;
             of basal cell carcinoma and melanoma in situ&#xD;
&#xD;
         11. Significantly impaired renal function (estimated Glomerular Filtration Rate (eGFR) &lt;&#xD;
             60 mL/min/1.73m2)&#xD;
&#xD;
         12. Significant impaired hepatic function (Alanine Aminotransferase &gt; 3 times upper limit&#xD;
             of normal or bilirubin &gt; 2 times upper limit of normal, except Gilbert syndrome)&#xD;
&#xD;
         13. Known allergic reactions to the active ingredients used or to constituents of the IMP&#xD;
&#xD;
         14. Chronic or active infection requiring a systemic therapy&#xD;
&#xD;
         15. Pregnancy, breastfeeding or planned pregnancy&#xD;
&#xD;
         16. Any condition that interferes with the participation in the clinical trial at the&#xD;
             discretion of the investigator&#xD;
&#xD;
         17. Patients not able to follow study instructions, not able to follow the study&#xD;
             assessments defined by the protocol, unable to understand the written and verbal&#xD;
             instructions, in particular regarding the risks and inconveniences they will be&#xD;
             exposed to during their participation in the clinical trial&#xD;
&#xD;
         18. Patients in custody by judicial or official order&#xD;
&#xD;
         19. Patients who are members of the staff of the trial centre, staff of the sponsor or&#xD;
             CRO, the investigator him/herself or close relatives of the investigator&#xD;
&#xD;
         20. Parallel participation in another clinical trial, participation in another trial&#xD;
             within less than 30 days or five half-lives of IMP (whatever is longer) to screening,&#xD;
             or previous participation in this trial (except one time screening failures). A&#xD;
             patient may be re-screened once, if any inclusion criterion is not met or any&#xD;
             exclusion criterion is met during the first screening attempt.&#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>Luitgard Spitznagel-Schminke</last_name>
    <role>Study Director</role>
    <affiliation>Bionorica SE</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Choceň</city>
        <zip>56501</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Havířov</city>
        <zip>73601</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Hradec Králové</city>
        <zip>50003</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative site</name>
      <address>
        <city>Hradec Králové</city>
        <zip>50341</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Olomouc</city>
        <zip>77520</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Plzen</city>
        <zip>31200</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Praha</city>
        <zip>10034</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Praha</city>
        <zip>12808</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Praha</city>
        <zip>14059</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Praha</city>
        <zip>18600</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Teplice</city>
        <zip>41529</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Ulm</city>
        <zip>89073</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Budapest</city>
        <zip>1024</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Budapest</city>
        <zip>1116</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Budapest</city>
        <zip>1145</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Debrecen</city>
        <zip>4031</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Győr</city>
        <zip>9024</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Miskolc</city>
        <zip>3526</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Szeged</city>
        <zip>6725</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Szolnok</city>
        <zip>5000</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Tatabánya</city>
        <zip>2800</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-065</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Częstochowa</city>
        <zip>42-280</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Katowice</city>
        <zip>40-555</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Katowice</city>
        <zip>40-588</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Katowice</city>
        <zip>40-611</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Katowice</city>
        <zip>40-650</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Kraków</city>
        <zip>30-539</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Plewiska</city>
        <zip>62-064</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Poznań</city>
        <zip>61-853</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Warszawa</city>
        <zip>00-874</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Warszawa</city>
        <zip>01-684</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Hospitalet de Llobregat</city>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Málaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Salt</city>
        <zip>17190</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Poland</country>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>May 4, 2021</last_update_submitted>
  <last_update_submitted_qc>May 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cannabinoid</keyword>
  <keyword>dronabinol</keyword>
  <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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>October 6, 2022</submitted>
    <returned>August 22, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03756974
org study id: DroSpas-1
nct id: NCT03756974
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To investigate the efficacy and safety of orally administered BX-1 compared to placebo in
      patients with spasticity due to multiple sclerosis not sufficiently controlled by current
      anti-spasticity medication
The aim of the present phase III clinical trial is to demonstrate superiority of BX-1, an
      oral solution containing dronabinol, over placebo in patients with spasticity due to MS not
      sufficiently controlled by their current anti-spasticity medication.

      The trial is designed to show that BX-1 is able to reduce spasticity in MS patients not
      showing sufficient response to their current anti-spasticity treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Responder analysis: proportion of patients showing improvement in spasticity of 18% or more in average Numerical Rating Scale for Spasticity (NRS-S) assessment at end of treatment
time frame: 16 weeks
description: Responder analysis: proportion of patients showing improvement in spasticity (change from baseline corresponding to the mean NRS-S score during 7 days prior to randomisation) of 18% or more in average NRS-S assessment at end of treatment (mean NRS-S score during 7 days prior to Visit 6).
measure: Responder analysis: proportion of patients showing improvement in spasticity (change from baseline) of 30% or more in average NRS-S assessment at end of treatment (Visit 6)
time frame: 16 weeks
measure: Responder analysis: proportion of patients showing improvement in spasticity (change from baseline) of 50% or more in average NRS-S assessment at end of treatment (Visit 6)
time frame: 16 weeks
measure: Time to response: time to reach first improvement in spasticity (change from baseline) of 18% or more, based on patient's daily spasticity assessment on the NRS-S
time frame: 16 weeks
measure: Time to response: time to reach first improvement in spasticity (change from baseline) of 30% or more, based on patient's daily spasticity assessment on the NRS-S
time frame: 16 weeks
measure: Weekly mean of the patient's daily spasticity assessments on the NRS-S during Visit 0 - Visit 6
time frame: 21 weeks
measure: Weekly mean of the patient's daily pain assessments on the Numerical Rating Scale for Pain (NRS-P) during Visit 0 - Visit 6
time frame: 21 weeks
measure: Responder analysis: proportion of patients showing improvement in pain (change from baseline) of 15% or more in average NRS-P assessment at end of treatment (Visit 6)
time frame: 16 weeks
measure: Responder analysis: proportion of patients showing improvement in pain (change from baseline) of 30% or more in average NRS-P assessment at end of treatment (Visit 6)
time frame: 16 weeks
measure: Time to response: time to reach first improvement in pain (change from baseline) of 15% or more, based on patient's pain assessment on the NRS-P
time frame: 16 weeks
measure: Time to response: time to reach first improvement in pain (change from baseline) of 30% or more, based on patient's pain assessment on the NRS-P
time frame: 16 weeks
measure: Weekly mean of the patient's daily spasm frequency and severity assessments on the Penn Spasm Frequency Scale (PSFS) during Visit 0 - Visit 6
time frame: 21 weeks
measure: Mean change from baseline of spasm frequency and severity assessments on the PSFS at end of treatment (Visit 6)
time frame: 16 weeks
measure: Mean change from baseline of Timed 25-Foot Walk (T25-FW) at Visit 4 and Visit 6
time frame: 16 weeks
measure: Responder analysis: proportion of patients showing improvement in TF25-FW (change from baseline) of 20% or more at Visit 6
time frame: 16 weeks
measure: Mean change from baseline of the physical and psychological impact of multiple sclerosis assessed with the Multiple Sclerosis Impact Scale- 29 version 2 (MSIS-29 v2) at Visit 4 and Visit 6
time frame: 16 weeks
measure: Mean change from baseline of quality of life measured with Short-Form Health Survey of the Medical Outcomes Study Version 2 (SF-36 v2) at Visit 6
time frame: 16 weeks
measure: Mean change from baseline of sleep quality measured with the Numerical Rating Scale for Sleep Quality (NRS-SQ) at Visit 3 - Visit 6
time frame: 12 weeks
measure: Mean change from baseline of fatigue measured with the Numerical Rating Scale for Fatigue (NRS-F) at Visit 3 - Visit 6
time frame: 12 weeks
measure: Overall patients' status measured by Patient´s Global Impression of Change scale (PGIC) at Visit 5 and Visit 6
time frame: 16 weeks
measure: Overall patients' status measured by Clinical Global Impression - Improvement scale (CGI-I) at Visit 5 and Visit 6
time frame: 16 weeks
arm group label: BX-1 (dronabinol)
arm group type: Experimental
description: BX-1
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo of BX-1
intervention type: Drug
intervention name: BX-1
description: BX-1 (dronabinol), oral solution. All patients enrolled establish their individually tolerable dose by dose Titration.
arm group label: BX-1 (dronabinol)
intervention type: Drug
intervention name: Placebo
description: Placebo of BX-1, oral solution
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Luitgard Spitznagel-Schminke
role: Study Director
affiliation: Bionorica SE
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country: Czechia
country: Germany
country: Hungary
country: Poland
country: Spain
responsible party type: Sponsor
mesh term: Muscle Spasticity
mesh term: Multiple Sclerosis
mesh term: Sclerosis
sharing ipd: No
submitted: October 6, 2022
returned: August 22, 2023