Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2026-01-01 @ 6:13 AM
Study NCT ID:
NCT01709968
Status:
TERMINATED
Last Update Posted:
2017-07-21
First Post:
2012-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnesium Oxide Monohydrate for Nocturnal Leg Cramps
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020922', 'term': 'Sleep-Wake Transition Disorders'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'whyStopped': 'Blinded interim analysis Recommendation, submitted April 1, 2014, was early termination for futility.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-18', 'studyFirstSubmitDate': '2012-10-17', 'studyFirstSubmitQcDate': '2012-10-17', 'lastUpdatePostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of documented episodes of NLC', 'timeFrame': '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;'}], 'secondaryOutcomes': [{'measure': 'Severity of documented episodes of NLC', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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;'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nocturnal Leg Cramps', 'Quality of life', 'Quality of sleep'], 'conditions': ['Nocturnal Leg Cramps', 'Quality of Life']}, 'referencesModule': {'references': [{'pmid': '28241153', 'type': 'RESULT', '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': '33275278', 'type': 'DERIVED', 'citation': 'Luo L, Zhou K, Zhang J, Xu L, Yin W. Interventions for leg cramps in pregnancy. Cochrane Database Syst Rev. 2020 Dec 4;12(12):CD010655. doi: 10.1002/14651858.CD010655.pub3.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/28241153', 'label': 'pubmed/28241153'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSigned informed consent before any procedure or assessment is done. Age over 21 years old. Over 4 episodes of documented NLC during 2 weeks of eligibility screening (for the treatment phase).\n\nInsured by Clalit Health Services (CHS). Hebrew speaking\n\nExclusion Criteria:\n\nPregnancy Currently taking Quinidine or Magnesium additive Renal failure - serum creatinine more than 2 mg/DL or estimated glomerular filtration rate (eGFR) less than 60 ml/min (the worst, ascertained by the participant electronic records in the last 6 months). If the result is near these limits (i.e. serum creatinin 1.5-2) a second analysis will be done near the study enrollment.\n\nMajor neurological disease- ALS, MS, Paraplegia or Quadriplegia.'}, 'identificationModule': {'nctId': 'NCT01709968', 'acronym': 'MgNLC', 'briefTitle': 'Magnesium Oxide Monohydrate for Nocturnal Leg Cramps', 'organization': {'class': 'OTHER', 'fullName': 'Clalit Health Services'}, 'officialTitle': 'Magnesium Oxide Monohydrate for Nocturnal Leg Cramps (MgNLC); a Prospective, Randomized, Double Blind, Placebo Controlled Clinical Trial.', 'orgStudyIdInfo': {'id': 'Com120009ctil'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MAGNOX 520®', '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.', 'interventionNames': ['Drug: MAGNOX 520®']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Similarly looking placebo.', 'description': 'Similarly looking placebo. Oral administration once daily for 4 weeks.', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'MAGNOX 520®', 'type': 'DRUG', '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', 'armGroupLabels': ['MAGNOX 520®']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['Similarly looking placebo'], 'description': 'Similarly looking placebo. Oral administration once daily for 4 weeks', 'armGroupLabels': ['Similarly looking placebo.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'facility': 'Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District,', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Noga Maor Rougin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District, HAIFA, ISRAEL'}, {'name': 'Uzi Milman, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District, HAIFA, ISRAEL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uzi Milman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director, Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL', 'investigatorFullName': 'Uzi Milman', 'investigatorAffiliation': 'Clalit Health Services'}}}}