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 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

Study Overview

• Status: Completed
• Conditions: Nocturnal Leg Cramps
• Intervention / Treatment: Other: Placebo; Dietary supplement: Magnox Comfort

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 Type: Interventional
• Enrollment (Actual): 216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ukraine
  • Kharkiv Region
    • Kharkiv, Kharkiv Region, Ukraine
      • Kharkiv City Clinic №9
  • Kyiv Region
    • Kyiv, Kyiv Region, Ukraine
      • Kyiv city clinic №9
    • Kyiv, Kyiv Region, Ukraine
      • Medical Center "Artem"
    • Kyiv, Kyiv Region, Ukraine
      • Medical center "Preventclinic" LLC
  • Lviv Region
    • Lviv, Lviv Region, Ukraine
      • City clinic №5
  • Odesa Region
    • Odesa, Odesa Region, Ukraine
      • Odesa Railway City Clinic
  • Ternopil' Region
    • Ternopil', Ternopil' Region, Ukraine
      • Medical center "Desna" LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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;
2. A study subject is a man or a woman over the age of 45 years;
3. The study subject has an established diagnosis of the nocturnal legs cramps;
4. The study subject understands the Ukrainian language;
5. The study subject has satisfactory results of the neurological examination of both lower extremities;
6. The study subject has a telephone and can use it permanently;

Exclusion Criteria:

1. The onset of one of the non-inclusion criteria;
2. The study subject has less than 4 episodes of NLC during the 14-day screening period;
3. There is necessity for significant change in the treatment tactics.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Magnox Comfort; 80 subjects will be on the Magnox Comfort arm.	Dietary supplement: Magnox Comfort; Magnox Comfort (Magnesium (226 mg in equivalent), Vitamin E - 45 mg, Vitamin B6 - 2 mg.).
PLACEBO_COMPARATOR: Placebo; 80 subjects will be on the Placebo arm.	Other: Placebo; placebo

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Naveh Pharma LTD
• Investigators: Study Director: Nitsan Primor, Naveh Pharma LTD

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 9, 2018
• Primary Completion (ACTUAL): August 27, 2018
• Study Completion (ACTUAL): August 27, 2018

Study Registration Dates

• First Submitted: January 9, 2019
• First Submitted That Met QC Criteria: January 12, 2019
• First Posted (ACTUAL): January 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 16, 2019
• Last Update Submitted That Met QC Criteria: January 12, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: nocturnal legs cramps; legs cramps; NLC
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Parasomnias; Sleep-Wake Transition Disorders
• Other Study ID Numbers: FS-MAG-1907

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No