Nocturnal Leg CrampsPhase 4MgNLCNCT01709968
Magnesium Oxide Monohydrate for Nocturnal Leg Cramps
A Phase 4 study testing MAGNOX 520® in people with Nocturnal Leg Cramps and Quality of Life, run by Uzi Milman at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Nocturnal Leg Cramps, Quality of Life
- What is being tested?
- MAGNOX 520®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2013to Apr 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed 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).
- Insured by Clalit Health Services (CHS). Hebrew speaking
Who cannot join
- Pregnancy 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.
- Major neurological disease- ALS, MS, Paraplegia or Quadriplegia.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District,
Haifa
About this study
Official title: Magnesium Oxide Monohydrate for Nocturnal Leg Cramps (MgNLC); a Prospective, Randomized, Double Blind, Placebo Controlled Clinical Trial.
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.
Read the detailed description
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.
- Conditions
- Nocturnal Leg Cramps, Quality of Life
- Being tested
- MAGNOX 520®, placebo
- Keywords
- Nocturnal Leg Cramps, Quality of life, Quality of sleep
- Medical subject headings
- Sleep-Wake Transition Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAGNOX 520®Drug
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
placeboDrug
Also called Similarly looking placebo
Similarly looking placebo. Oral administration once daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| MAGNOX 520® | Experimental | 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. Receives: Drug: MAGNOX 520® |
| Similarly looking placebo. | Placebo comparator | Similarly looking placebo. Oral administration once daily for 4 weeks. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of documented episodes of NLC
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;
Measured: 4 weeks
Secondary outcomes (4)
Severity of documented episodes of NLC
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;
Measured: 4 weeks
Duration of documented episodes of NLC documented
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
Measured: 4 weeks
Quality of life
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;
Measured: 4 weeks
Quality of sleep
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;
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study startFeb 2013
- Primary completionOct 2013
- Study completionApr 2014
Why it stopped: Blinded interim analysis Recommendation, submitted April 1, 2014, was early termination for futility.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nocturnal Leg CrampsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uzi Milman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Uzi Milman, Clalit Health Services
- Investigators
- Noga Maor Rougin, MD, Principal investigator, Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District, HAIFA, ISRAELUzi Milman, MD, Study director, Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District, HAIFA, ISRAEL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709968
- Sponsor's protocol ID
- Com120009ctil
- Acronym
- MgNLC
- Status last verified
- Jul 2017
- First submitted
- 17 Oct 2012
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28241153Luo 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.
PubMed 33275278
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium Oxide Monohydrate for Nocturnal Leg Cramps (MgNLC); a Prospective, Randomized, Double Blind, Placebo Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT01709968
- Acronym / sponsor ID
- MgNLC / Com120009ctil
- Conditions
- Nocturnal Leg Cramps, Quality of Life
- Keywords
- Nocturnal Leg Cramps, Quality of life, Quality of sleep
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Blinded interim analysis Recommendation, submitted April 1, 2014, was early termination for futility.
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Uzi MilmanUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 18 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MAGNOX 520® | Experimental | Drug: MAGNOX 520®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. |
| Similarly looking placebo. | Placebo comparator | Drug: placeboSimilarly looking placebo. Oral administration once daily for 4 weeks. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed 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).
- Insured by Clalit Health Services (CHS). Hebrew speaking
Key exclusion criteria (2 listed)
- Pregnancy 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.
- Major neurological disease- ALS, MS, Paraplegia or Quadriplegia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | MAGNOX 520® |
| placeboAlso: Similarly looking placeboSimilarly looking placebo. Oral administration once daily for 4 weeks | Drug | Similarly looking placebo. |
Primary outcome
Number of documented episodes of NLC
Time frame: 4 weeks
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;
4 secondary outcomes
Severity of documented episodes of NLC
Time frame: 4 weeks
Duration of documented episodes of NLC documented
Time frame: 4 weeks
Quality of life
Time frame: 4 weeks
Quality of sleep
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: Blinded interim analysis Recommendation, submitted April 1, 2014, was early termination for futility.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Results publication: PubMed 28241153Roguin 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.
- Derived from this study: PubMed 33275278Luo 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.
- pubmed/28241153Link provided by the sponsor.
Related trials for Nocturnal Leg Cramps
Recruiting
The Effect of a Daily Magnesium and Melatonin Supplement on Sleep Quality in People With Nighttime Leg Cramps
Poor Sleep Quality, Leg Cramps, Nocturnal
Not yet recruiting
Weighted Blanket in Pregnancy
Leg Cramps, Nocturnal, Poor Sleep Quality
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noga Maor Rougin, MD principal investigator
Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District, HAIFA, ISRAEL
Uzi Milman, MD study director
Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District, HAIFA, ISRAEL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MAGNOX 520® in people with Nocturnal Leg Cramps and Quality of Life, run by Uzi Milman at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Blinded interim analysis Recommendation, submitted April 1, 2014, was early termination for futility.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of documented episodes of NLC (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01709968, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.