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

Nocturnal Leg Cramps Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03807219
• Other study ID #: FS-MAG-1907
• Status: Completed
• Phase: N/A
• Start date: February 9, 2018
• Est. completion date: August 27, 2018

Study information

• Verified date: January 2019
• Source: Naveh Pharma LTD
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: August 27, 2018
• Est. primary completion date: August 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nocturnal Leg Cramps

Intervention

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

Other:
• Placebo
placebo

Locations

Country	Name	City	State
Ukraine	Kharkiv City Clinic ?9	Kharkiv	Kharkiv Region
Ukraine	Kyiv city clinic ?9	Kyiv	Kyiv Region
Ukraine	Medical Center "Artem"	Kyiv	Kyiv Region
Ukraine	Medical Center "Preventclinic" LLC	Kyiv	Kyiv Region
Ukraine	City clinic ?5	Lviv	Lviv Region
Ukraine	Odesa Railway City Clinic	Odesa	Odesa Region
Ukraine	Medical center "Desna" LLC	Ternopil'	Ternopil` Region

Sponsors (1)

Lead Sponsor	Collaborator
Naveh Pharma LTD

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.