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

Not Applicable

Completed

• Conditions: Nocturnal Leg Cramps
• Interventions: Other: Placebo; Dietary Supplement: Magnox Comfort

• Registration Number: NCT03807219
• Lead Sponsor: Naveh Pharma LTD

Brief 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

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 Timeline

• Study Start: 2018-02-09
• Primary Completion: 2018-08-27
• Study Completion: 2018-08-27
• Status Verified: 2019-01
• Study First Submitted: 2019-01-09
• Study First Submitted QC: 2019-01-12
• Last Update Submitted: 2019-01-12
• Study First Posted: 2019-01-16
• Last Update Posted: 2019-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	80 subjects will be on the Placebo arm.
Magnox Comfort	Magnox Comfort	80 subjects will be on the Magnox Comfort arm.

Primary Outcome Measures

Name	Time	Method
The number of episodes of NLC	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 Outcome Measures

Name	Time	Method
Change in quality of life (SF-36)	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.
Drop-out rate	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
Duration of NLC	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
Severity of pain associated with NLC	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
Changing in the sleep quality	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

Trial Locations

Locations (7)

Kharkiv City Clinic №9; 🇺🇦 Kharkiv, Kharkiv Region, Ukraine

Medical Center "Preventclinic" LLC; 🇺🇦 Kyiv, Kyiv Region, Ukraine

City clinic №5; 🇺🇦 Lviv, Lviv Region, Ukraine

Medical center "Desna" LLC; 🇺🇦 Ternopil', Ternopil' Region, Ukraine

Kyiv city clinic №9; 🇺🇦 Kyiv, Kyiv Region, Ukraine

Medical Center "Artem"; 🇺🇦 Kyiv, Kyiv Region, Ukraine

Odesa Railway City Clinic; 🇺🇦 Odesa, Odesa Region, Ukraine