The Study of Efficacy and Safety of a 60-day Use of the Magnox Comfort Compared to the Placebo in Subjects With NLC

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Nocturnal Leg Cramps

Intervention / Treatment
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* Dietary Supplement: Magnox Comfort
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Magnox Comfort<br>80 subjects will be on the Magnox Comfort arm. | Dietary Supplement: Magnox Comfort<br>* Magnox Comfort (Magnesium (226 mg in equivalent), Vitamin E - 45 mg, Vitamin B6 - 2 mg.).<br>|
| Placebo Comparator: Placebo<br>80 subjects will be on the Placebo arm. | Other: Placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of NLC | The study subject will record the length of cramps in the diary | 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 | 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. | 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 | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NLC, legs cramps, nocturnal legs cramps