<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/NCT03807219</url>
  </required_header>
  <id_info>
    <org_study_id>FS-MAG-1907</org_study_id>
    <nct_id>NCT03807219</nct_id>
  </id_info>
  <brief_title>The Study of Efficacy and Safety of a 60-day Use of the Magnox Comfort Compared to the Placebo in Subjects With NLC</brief_title>
  <official_title>A Randomized, Multicenter, Prospective, Double-blind, Placebo-controlled, Clinical Trial in the Parallel Groups to Determine the Efficacy and Safety of a 60-day Use of the Magnox Comfort Compared to the Placebo in Subjects With NLC</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Naveh Pharma LTD</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Naveh Pharma LTD</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>
      A randomized, multicenter, prospective, double-blind, placebo-controlled, clinical trial in&#xD;
      the parallel groups to determine the efficacy and safety of a 60-day use of the dietary&#xD;
      supplement Magnox Comfort compared to the placebo in subjects with nocturnal legs cramps&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At the beginning of the study, study subjects undergo a 14-day screening period during which&#xD;
      the number of episodes of NLC is recorded. For further participation in the study, they must&#xD;
      have at least 4 NLC episodes. Thereafter, an examination of compliance with the study&#xD;
      requirements is performed and study subjects are randomized to one of the two groups: for a&#xD;
      60-day of IP use (1 capsule of Magnox Comfort daily) or to the control group (1 capsule of&#xD;
      placebo daily).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 9, 2018</start_date>
  <completion_date type="Actual">August 27, 2018</completion_date>
  <primary_completion_date type="Actual">August 27, 2018</primary_completion_date>
  <phase>N/A</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>The number of episodes of NLC</measure>
    <time_frame>The difference in count of nocturnal legs cramps documented in the trial, as compared between the study product and the placebo treated individuals, during a treatment period of 60-day.</time_frame>
    <description>The study subject will record the number of episodes of nocturnal legs cramps in the study subject's diary</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of NLC</measure>
    <time_frame>The difference in duration of nocturnal legs cramps documented in the trial, as compared between the study product and the placebo treated individuals, during a treatment period of 60-day.</time_frame>
    <description>The study subject will record the length of cramps in the diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of pain associated with NLC</measure>
    <time_frame>The difference in severity of pain of nocturnal legs cramps documented in the trial, as compared between the study product and the placebo treated individuals, during a treatment period of 60-day.</time_frame>
    <description>The study subject will record the severity of cramps in the diary using the visual analog scale from 0 to 10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life (SF-36)</measure>
    <time_frame>The difference in quality of life documented in the trial, as compared between the study product and the placebo treated individuals, during a treatment period of 60-day.</time_frame>
    <description>Study Short Form 36 Health Survey (SF-36) is one of the most widely used universal HRQoL scales, and it is widely used in the HRQoL measurement of general population, evaluation of clinical trials and health policy evaluation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changing in the sleep quality</measure>
    <time_frame>The difference in sleep quality documented in the trial, as compared between the study product and the placebo treated individuals, during a treatment period of 60-day.</time_frame>
    <description>The evaluation will be conducted using VAS (visual analog scale) from 0 to 5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drop-out rate</measure>
    <time_frame>The difference in drop-out rate documented in the trial, as compared between the study product and the placebo treated individuals, during a treatment period of 60-day.</time_frame>
    <description>Counts of drop-out subjects</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">216</enrollment>
  <condition>Nocturnal Leg Cramps</condition>
  <arm_group>
    <arm_group_label>Magnox Comfort</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>80 subjects will be on the Magnox Comfort arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>80 subjects will be on the Placebo arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Magnox Comfort</intervention_name>
    <description>Magnox Comfort (Magnesium (226 mg in equivalent), Vitamin E - 45 mg, Vitamin B6 - 2 mg.).</description>
    <arm_group_label>Magnox Comfort</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</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;
          1. The study subject is informed and he/she was given enough time to think on his&#xD;
             participation in the study and signed the informed consent form before the beginning&#xD;
             of any procedures;&#xD;
&#xD;
          2. A study subject is a man or a woman over the age of 45 years;&#xD;
&#xD;
          3. The study subject has an established diagnosis of the nocturnal legs cramps;&#xD;
&#xD;
          4. The study subject understands the Ukrainian language;&#xD;
&#xD;
          5. The study subject has satisfactory results of the neurological examination of both&#xD;
             lower extremities;&#xD;
&#xD;
          6. The study subject has a telephone and can use it permanently;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The onset of one of the non-inclusion criteria;&#xD;
&#xD;
          2. The study subject has less than 4 episodes of NLC during the 14-day screening period;&#xD;
&#xD;
          3. There is necessity for significant change in the treatment tactics.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nitsan Primor</last_name>
    <role>Study Director</role>
    <affiliation>Naveh Pharma LTD</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kharkiv City Clinic №9</name>
      <address>
        <city>Kharkiv</city>
        <state>Kharkiv Region</state>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyiv city clinic №9</name>
      <address>
        <city>Kyiv</city>
        <state>Kyiv Region</state>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center &quot;Artem&quot;</name>
      <address>
        <city>Kyiv</city>
        <state>Kyiv Region</state>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center &quot;Preventclinic&quot; LLC</name>
      <address>
        <city>Kyiv</city>
        <state>Kyiv Region</state>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City clinic №5</name>
      <address>
        <city>Lviv</city>
        <state>Lviv Region</state>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odesa Railway City Clinic</name>
      <address>
        <city>Odesa</city>
        <state>Odesa Region</state>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical center &quot;Desna&quot; LLC</name>
      <address>
        <city>Ternopil'</city>
        <state>Ternopil' Region</state>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ukraine</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>January 12, 2019</last_update_submitted>
  <last_update_submitted_qc>January 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>nocturnal legs cramps</keyword>
  <keyword>legs cramps</keyword>
  <keyword>NLC</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep-Wake Transition Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03807219
org study id: FS-MAG-1907
nct id: NCT03807219
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A randomized, multicenter, prospective, double-blind, placebo-controlled, clinical trial in
      the parallel groups to determine the efficacy and safety of a 60-day use of the dietary
      supplement Magnox Comfort compared to the placebo in subjects with nocturnal legs cramps
At the beginning of the study, study subjects undergo a 14-day screening period during which
      the number of episodes of NLC is recorded. For further participation in the study, they must
      have at least 4 NLC episodes. Thereafter, an examination of compliance with the study
      requirements is performed and study subjects are randomized to one of the two groups: for a
      60-day of IP use (1 capsule of Magnox Comfort daily) or to the control group (1 capsule of
      placebo daily).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: The number of episodes of NLC
time frame: The difference in count of nocturnal legs cramps documented in the trial, as compared between the study product and the placebo treated individuals, during a treatment period of 60-day.
description: The study subject will record the number of episodes of nocturnal legs cramps in the study subject's diary
measure: Duration of NLC
time frame: The difference in duration of nocturnal legs cramps documented in the trial, as compared between the study product and the placebo treated individuals, during a treatment period of 60-day.
description: The study subject will record the length of cramps in the diary
measure: Severity of pain associated with NLC
time frame: The difference in severity of pain of nocturnal legs cramps documented in the trial, as compared between the study product and the placebo treated individuals, during a treatment period of 60-day.
description: The study subject will record the severity of cramps in the diary using the visual analog scale from 0 to 10
measure: Change in quality of life (SF-36)
time frame: The difference in quality of life documented in the trial, as compared between the study product and the placebo treated individuals, during a treatment period of 60-day.
description: Study Short Form 36 Health Survey (SF-36) is one of the most widely used universal HRQoL scales, and it is widely used in the HRQoL measurement of general population, evaluation of clinical trials and health policy evaluation.
measure: Changing in the sleep quality
time frame: The difference in sleep quality documented in the trial, as compared between the study product and the placebo treated individuals, during a treatment period of 60-day.
description: The evaluation will be conducted using VAS (visual analog scale) from 0 to 5
measure: Drop-out rate
time frame: The difference in drop-out rate documented in the trial, as compared between the study product and the placebo treated individuals, during a treatment period of 60-day.
description: Counts of drop-out subjects
arm group label: Magnox Comfort
arm group type: Active Comparator
description: 80 subjects will be on the Magnox Comfort arm.
arm group label: Placebo
arm group type: Placebo Comparator
description: 80 subjects will be on the Placebo arm.
intervention type: Dietary Supplement
intervention name: Magnox Comfort
description: Magnox Comfort (Magnesium (226 mg in equivalent), Vitamin E - 45 mg, Vitamin B6 - 2 mg.).
arm group label: Magnox Comfort
intervention type: Other
intervention name: Placebo
description: placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: No
last name: Nitsan Primor
role: Study Director
affiliation: Naveh Pharma LTD
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Ukraine
responsible party type: Sponsor
mesh term: Sleep-Wake Transition Disorders
sharing ipd: No