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NCT Number: NCT03807219

The Study of 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

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Key information

Conditions

Nocturnal Leg Cramps Mental Disorders Nervous System Diseases Parasomnias Sleep Wake Disorders Sleep-Wake Transition Disorders

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kharkiv City Clinic №9, Kharkiv, Kharkiv Oblast, Ukraine

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnox Comfort

Dietary Supplement

Magnox Comfort (Magnesium (226 mg in equivalent), Vitamin E - 45 mg, Vitamin B6 - 2 mg.).

Placebo

Other

placebo

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

    The study subject will record the length of cramps in the diary

  2. 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.

    The study subject will record the severity of cramps in the diary using the visual analog scale from 0 to 10

  3. 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.

    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.

  4. 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.

    The evaluation will be conducted using VAS (visual analog scale) from 0 to 5

  5. 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.

    Counts of drop-out subjects

Sponsors and collaborators

Lead sponsor

Naveh Pharma LTD

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 16, 2019
Registry last updated
Jan 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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