<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/NCT01709968</url>
  </required_header>
  <id_info>
    <org_study_id>Com120009ctil</org_study_id>
    <nct_id>NCT01709968</nct_id>
  </id_info>
  <brief_title>Magnesium Oxide Monohydrate for Nocturnal Leg Cramps</brief_title>
  <acronym>MgNLC</acronym>
  <official_title>Magnesium Oxide Monohydrate for Nocturnal Leg Cramps (MgNLC); a Prospective, Randomized, Double Blind, Placebo Controlled Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Uzi Milman</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clalit Health Services</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nocturnal leg cramps (NLC) are painful, involuntary contractions of muscles occurring at&#xD;
      rest, mostly at night. A Cochrane review on leg cramps in pregnancy showed some potential&#xD;
      benefits in trials of magnesium. This is a single center, prospective, randomized, double&#xD;
      blind, placebo controlled clinical trial that aims to investigate the effect of treatment&#xD;
      with Magnox 520® (un-organic granular magnesium complex, composed of Magnesium Oxide &amp;&#xD;
      Magnesium Oxide Monohydrate 865mg, Provides 520 mg of free elemental Mg++) on frequency and&#xD;
      severity of NLC, quality of sleep and quality of life. Hypothesis: Magnox 520® may reduce the&#xD;
      number and severity of NLC; an improvement in the quality of life and quality of sleep may&#xD;
      ensue.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ads in the local media and pharmacies will invite individuals afflicted by NLC to participate&#xD;
      in the study. Each participating individual will undergo two weeks of eligibility screening&#xD;
      followed by 4-week double-blind treatment. The number, severity and duration of NLC will be&#xD;
      measured daily as documented in a designated, structured sleep dairy. Quality of life and&#xD;
      quality of sleep will be assessed by SF-36 and PSQI questionnaires, respectively, to be&#xD;
      completed twice - at enrollment and within one week of the end of the treatment period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Blinded interim analysis Recommendation, submitted April 1, 2014, was early termination for&#xD;
    futility.&#xD;
  </why_stopped>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">October 2013</primary_completion_date>
  <phase>Phase 4</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>Number of documented episodes of NLC</measure>
    <time_frame>4 weeks</time_frame>
    <description>The primary efficacy endpoint is the difference in the number of episodes of NLC documented in the NCSD, as compared between the MAGNOX 520® and the placebo treated individuals, during a treatment period of 4 weeks;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Severity of documented episodes of NLC</measure>
    <time_frame>4 weeks</time_frame>
    <description>The difference in the severity of episodes of NLC documented in the NCSD, as compared between the MAGNOX 520® and the placebo treated individuals, during a treatment period of 4 weeks;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of documented episodes of NLC documented</measure>
    <time_frame>4 weeks</time_frame>
    <description>The difference in the duration of episodes of NLC documented in the NCSD, as compared between the MAGNOX 520® and the placebo treated individuals, during a</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>4 weeks</time_frame>
    <description>The difference in the change in quality of life (measured by SF36 at enrolment and after the treatment period) between the MAGNOX 520® and the placebo treated individuals;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of sleep</measure>
    <time_frame>4 weeks</time_frame>
    <description>The difference in the change in quality of sleep (measured by PSQI at enrolment and after the treatment period) between the MAGNOX 520® and the placebo treated individuals;</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">94</enrollment>
  <condition>Nocturnal Leg Cramps</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>MAGNOX 520®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MAGNOX 520® (un-organic granular magnesium complex, composed of Magnesium Oxide &amp; Magnesium Oxide Monohydrate 865mg, Provides 520 mg of free elemental Mg ++); Oral administration once daily for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Similarly looking placebo.</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Similarly looking placebo. Oral administration once daily for 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MAGNOX 520®</intervention_name>
    <description>un-organic granular magnesium complex, composed of Magnesium Oxide &amp; Magnesium Oxide Monohydrate 865mg, Provides 520 mg of free elemental Mg ++); Oral administration once daily for 4 weeks</description>
    <arm_group_label>MAGNOX 520®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>Similarly looking placebo. Oral administration once daily for 4 weeks</description>
    <arm_group_label>Similarly looking placebo.</arm_group_label>
    <other_name>Similarly looking placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Signed informed consent before any procedure or assessment is done. Age over 21 years old.&#xD;
        Over 4 episodes of documented NLC during 2 weeks of eligibility screening (for the&#xD;
        treatment phase).&#xD;
&#xD;
        Insured by Clalit Health Services (CHS). Hebrew speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Pregnancy Currently taking Quinidine or Magnesium additive Renal failure - serum creatinine&#xD;
        more than 2 mg/DL or estimated glomerular filtration rate (eGFR) less than 60 ml/min (the&#xD;
        worst, ascertained by the participant electronic records in the last 6 months). If the&#xD;
        result is near these limits (i.e. serum creatinin 1.5-2) a second analysis will be done&#xD;
        near the study enrollment.&#xD;
&#xD;
        Major neurological disease- ALS, MS, Paraplegia or Quadriplegia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Noga Maor Rougin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District, HAIFA, ISRAEL</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Uzi Milman, MD</last_name>
    <role>Study Director</role>
    <affiliation>Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District, HAIFA, ISRAEL</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District,</name>
      <address>
        <city>Haifa,</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/28241153</url>
    <description>pubmed/28241153</description>
  </link>
  <results_reference>
    <citation>Roguin Maor N, Alperin M, Shturman E, Khairaldeen H, Friedman M, Karkabi K, Milman U. Effect of Magnesium Oxide Supplementation on Nocturnal Leg Cramps: A Randomized Clinical Trial. JAMA Intern Med. 2017 May 1;177(5):617-623. doi: 10.1001/jamainternmed.2016.9261.</citation>
    <PMID>28241153</PMID>
  </results_reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>July 18, 2017</last_update_submitted>
  <last_update_submitted_qc>July 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Clalit Health Services</investigator_affiliation>
    <investigator_full_name>Uzi Milman</investigator_full_name>
    <investigator_title>Director, Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL</investigator_title>
  </responsible_party>
  <keyword>Nocturnal Leg Cramps</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Quality of sleep</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Cramp</mesh_term>
    <mesh_term>Spasm</mesh_term>
    <mesh_term>Sleep-Wake Transition Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01709968
org study id: Com120009ctil
nct id: NCT01709968
lead sponsor: 
has dmc: Yes
Nocturnal leg cramps (NLC) are painful, involuntary contractions of muscles occurring at
      rest, mostly at night. A Cochrane review on leg cramps in pregnancy showed some potential
      benefits in trials of magnesium. This is a single center, prospective, randomized, double
      blind, placebo controlled clinical trial that aims to investigate the effect of treatment
      with Magnox 520® (un-organic granular magnesium complex, composed of Magnesium Oxide &
      Magnesium Oxide Monohydrate 865mg, Provides 520 mg of free elemental Mg++) on frequency and
      severity of NLC, quality of sleep and quality of life. Hypothesis: Magnox 520® may reduce the
      number and severity of NLC; an improvement in the quality of life and quality of sleep may
      ensue.
Ads in the local media and pharmacies will invite individuals afflicted by NLC to participate
      in the study. Each participating individual will undergo two weeks of eligibility screening
      followed by 4-week double-blind treatment. The number, severity and duration of NLC will be
      measured daily as documented in a designated, structured sleep dairy. Quality of life and
      quality of sleep will be assessed by SF-36 and PSQI questionnaires, respectively, to be
      completed twice - at enrollment and within one week of the end of the treatment period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of documented episodes of NLC
time frame: 4 weeks
description: The primary efficacy endpoint is the difference in the number of episodes of NLC documented in the NCSD, as compared between the MAGNOX 520® and the placebo treated individuals, during a treatment period of 4 weeks;
measure: Severity of documented episodes of NLC
time frame: 4 weeks
description: The difference in the severity of episodes of NLC documented in the NCSD, as compared between the MAGNOX 520® and the placebo treated individuals, during a treatment period of 4 weeks;
measure: Duration of documented episodes of NLC documented
time frame: 4 weeks
description: The difference in the duration of episodes of NLC documented in the NCSD, as compared between the MAGNOX 520® and the placebo treated individuals, during a
measure: Quality of life
time frame: 4 weeks
description: The difference in the change in quality of life (measured by SF36 at enrolment and after the treatment period) between the MAGNOX 520® and the placebo treated individuals;
measure: Quality of sleep
time frame: 4 weeks
description: The difference in the change in quality of sleep (measured by PSQI at enrolment and after the treatment period) between the MAGNOX 520® and the placebo treated individuals;
arm group label: MAGNOX 520®
arm group type: Experimental
description: MAGNOX 520® (un-organic granular magnesium complex, composed of Magnesium Oxide & Magnesium Oxide Monohydrate 865mg, Provides 520 mg of free elemental Mg ++); Oral administration once daily for 4 weeks.
arm group label: Similarly looking placebo.
arm group type: Placebo Comparator
description: Similarly looking placebo. Oral administration once daily for 4 weeks.
intervention type: Drug
intervention name: MAGNOX 520®
description: un-organic granular magnesium complex, composed of Magnesium Oxide & Magnesium Oxide Monohydrate 865mg, Provides 520 mg of free elemental Mg ++); Oral administration once daily for 4 weeks
arm group label: MAGNOX 520®
intervention type: Drug
intervention name: placebo
description: Similarly looking placebo. Oral administration once daily for 4 weeks
arm group label: Similarly looking placebo.
other name: Similarly looking placebo
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Noga Maor Rougin, MD
role: Principal Investigator
affiliation: Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District, HAIFA, ISRAEL
last name: Uzi Milman, MD
role: Study Director
affiliation: Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District, HAIFA, ISRAEL
facility: 
country: Israel
url: https://www.ncbi.nlm.nih.gov/pubmed/28241153
description: pubmed/28241153
citation: Roguin Maor N, Alperin M, Shturman E, Khairaldeen H, Friedman M, Karkabi K, Milman U. Effect of Magnesium Oxide Supplementation on Nocturnal Leg Cramps: A Randomized Clinical Trial. JAMA Intern Med. 2017 May 1;177(5):617-623. doi: 10.1001/jamainternmed.2016.9261.
PMID: 28241153
responsible party type: Sponsor-Investigator
investigator affiliation: Clalit Health Services
investigator full name: Uzi Milman
investigator title: Director, Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL
mesh term: Muscle Cramp
mesh term: Spasm
mesh term: Sleep-Wake Transition Disorders