Nocturnal Leg CrampsNCT03807219
The Study of Efficacy and Safety of a 60-day Use of the Magnox Comfort Compared to the Placebo in Subjects With NLC
A study testing Magnox Comfort in people with Nocturnal Leg Cramps, run by Naveh Pharma LTD at 7 sites in Ukraine.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Nocturnal Leg Cramps
- What is being tested?
- Magnox Comfort
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 7 sitesUkraine
- Study dates
- 9 Feb 2018to 27 Aug 2018
- Phase
- Interventional
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The study subject is informed and he/she was given enough time to think on his participation in the study and signed the informed consent form before the beginning of any procedures;
- A study subject is a man or a woman over the age of 45 years;
- The study subject has an established diagnosis of the nocturnal legs cramps;
- The study subject understands the Ukrainian language;
- The study subject has satisfactory results of the neurological examination of both lower extremities;
- The study subject has a telephone and can use it permanently;
Who cannot join
- The onset of one of the non-inclusion criteria;
- The study subject has less than 4 episodes of NLC during the 14-day screening period;
- There is necessity for significant change in the treatment tactics.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Ukraine7 sites
Kharkiv City Clinic №9
Kharkiv, Kharkiv Oblast
Kyiv city clinic №9
Kyiv, Kyiv Oblast
Medical Center "Artem"
Kyiv, Kyiv Oblast
Medical Center "Preventclinic" LLC
Kyiv, Kyiv Oblast
City clinic №5
Lviv, Lviv Oblast
Odesa Railway City Clinic
Odesa, Odesa Oblast
Medical center "Desna" LLC
Ternopil, Ternopil Oblast
About this study
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
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
Read the detailed description
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).
- Conditions
- Nocturnal Leg Cramps
- Being tested
- Magnox Comfort, Placebo
- Keywords
- nocturnal legs cramps, legs cramps, NLC
- Medical subject headings
- Sleep-Wake Transition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnox ComfortDietary supplement
Magnox Comfort (Magnesium (226 mg in equivalent), Vitamin E - 45 mg, Vitamin B6 - 2 mg.).
PlaceboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| Magnox Comfort | Active comparator | 80 subjects will be on the Magnox Comfort arm. Receives: Dietary Supplement: Magnox Comfort |
| Placebo | Placebo comparator | 80 subjects will be on the Placebo arm. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of episodes of NLC
The study subject will record the number of episodes of nocturnal legs cramps in the study subject's diary
Measured: 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.
Secondary outcomes (5)
Duration of NLC
The study subject will record the length of cramps in the diary
Measured: 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.
Severity of pain associated with NLC
The study subject will record the severity of cramps in the diary using the visual analog scale from 0 to 10
Measured: 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.
Change in quality of life (SF-36)
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.
Measured: 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.
Changing in the sleep quality
The evaluation will be conducted using VAS (visual analog scale) from 0 to 5
Measured: 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.
Drop-out rate
Counts of drop-out subjects
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start9 Feb 2018
- Primary completion27 Aug 2018
- Study completion27 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naveh Pharma LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nitsan Primor, Study director, Naveh Pharma LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807219
- Sponsor's protocol ID
- FS-MAG-1907
- Status last verified
- Jan 2019
- First submitted
- 9 Jan 2019
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barna O, Lohoida P, Holovchenko Y, Bazylevych A, Velychko V, Hovbakh I, Bula L, Shechter M. A randomized, double-blind, placebo-controlled, multicenter study assessing the efficacy of magnesium oxide monohydrate in the treatment of nocturnal leg cramps. Nutr J. 2021 Oct 31;20(1):90. doi: 10.1186/s12937-021-00747-9.
PubMed 34719399
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03807219
- Acronym / sponsor ID
- FS-MAG-1907
- Conditions
- Nocturnal Leg Cramps
- Keywords
- nocturnal legs cramps, legs cramps, NLC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Naveh Pharma LTDIndustry (pharma, biotech, devices)
- Study start
- 9 Feb 2018 (actual)
- Primary completion
- 27 Aug 2018 (actual)
- Study completion
- 27 Aug 2018 (actual)
- First posted
- 16 Jan 2019 (actual)
- 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.
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
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnox Comfort | Active comparator | Dietary Supplement: Magnox Comfort80 subjects will be on the Magnox Comfort arm. |
| Placebo | Placebo comparator | Other: Placebo80 subjects will be on the Placebo arm. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The study subject is informed and he/she was given enough time to think on his participation in the study and signed the informed consent form before the beginning of any procedures;
- A study subject is a man or a woman over the age of 45 years;
- The study subject has an established diagnosis of the nocturnal legs cramps;
- The study subject understands the Ukrainian language;
- The study subject has satisfactory results of the neurological examination of both lower extremities;
Key exclusion criteria (3 listed)
- The onset of one of the non-inclusion criteria;
- The study subject has less than 4 episodes of NLC during the 14-day screening period;
- There is necessity for significant change in the treatment tactics.
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 ComfortMagnox Comfort (Magnesium (226 mg in equivalent), Vitamin E - 45 mg, Vitamin B6 - 2 mg.). | Dietary supplement | Magnox Comfort |
| Placeboplacebo | Other | Placebo |
Primary outcome
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.
The study subject will record the number of episodes of nocturnal legs cramps in the study subject's diary
5 secondary outcomes
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Derived from this study: PubMed 34719399Barna O, Lohoida P, Holovchenko Y, Bazylevych A, Velychko V, Hovbakh I, Bula L, Shechter M. A randomized, double-blind, placebo-controlled, multicenter study assessing the efficacy of magnesium oxide monohydrate in the treatment of nocturnal leg cramps. Nutr J. 2021 Oct 31;20(1):90. doi: 10.1186/s12937-021-00747-9.
- Individual participant dataSharing planned: No
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.
Nitsan Primor study director
Naveh Pharma LTD
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnox Comfort in people with Nocturnal Leg Cramps, run by Naveh Pharma LTD at 7 sites in Ukraine.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Ukraine. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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.). 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 NCT03807219, which also lists 1 linked publication.
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 16 Jan 2019.