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

Primary Purpose

Nocturnal Leg Cramps

Status

Completed

Phase

Not Applicable

Locations

Ukraine

Study Type

Interventional

Intervention

Magnox Comfort

Placebo

About this trial

This is an interventional treatment trial for Nocturnal Leg Cramps focused on measuring nocturnal legs cramps, legs cramps, NLC

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Kharkiv City Clinic №9
Kyiv city clinic №9
Medical Center "Artem"
Medical Center "Preventclinic" LLC
City clinic №5
Odesa Railway City Clinic
Medical center "Desna" LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Magnox Comfort

Placebo

Arm Description

80 subjects will be on the Magnox Comfort arm.

80 subjects will be on the Placebo arm.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Duration of NLC

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

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

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.

Changing in the sleep quality

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

Drop-out rate

Counts of drop-out subjects

Full Information

NCT ID

NCT03807219

First Posted

January 9, 2019

Last Updated

January 12, 2019

Sponsor

Naveh Pharma LTD

1. Study Identification

Unique Protocol Identification Number

NCT03807219

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

February 9, 2018 (Actual)

Primary Completion Date

August 27, 2018 (Actual)

Study Completion Date

August 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Naveh Pharma LTD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nocturnal Leg Cramps

Keywords

nocturnal legs cramps, legs cramps, NLC

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

216 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Magnox Comfort

Arm Type

Active Comparator

Arm Description

80 subjects will be on the Magnox Comfort arm.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

80 subjects will be on the Placebo arm.

Intervention Type

Dietary Supplement

Intervention Name(s)

Magnox Comfort

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

placebo

Primary Outcome Measure Information:

Title

The number of episodes of NLC

Description

The study subject will record the number of episodes of nocturnal legs cramps in the study subject's diary

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.

Secondary Outcome Measure Information:

Title

Duration of NLC

Description

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

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.

Title

Severity of pain associated with NLC

Description

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

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.

Title

Change in quality of life (SF-36)

Description

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.

Title

Changing in the sleep quality

Description

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

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.

Title

Drop-out rate

Description

Counts of drop-out subjects

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nitsan Primor

Organizational Affiliation

Naveh Pharma LTD

Official's Role

Study Director

Facility Information:

Facility Name

Kharkiv City Clinic №9

City

Kharkiv

State/Province

Kharkiv Region

Country

Ukraine

Facility Name

Kyiv city clinic №9

City

Kyiv

State/Province

Kyiv Region

Country

Ukraine

Facility Name

Medical Center "Artem"

City

Kyiv

State/Province

Kyiv Region

Country

Ukraine

Facility Name

Medical Center "Preventclinic" LLC

City

Kyiv

State/Province

Kyiv Region

Country

Ukraine

Facility Name

City clinic №5

City

Lviv

State/Province

Lviv Region

Country

Ukraine

Facility Name

Odesa Railway City Clinic

City

Odesa

State/Province

Odesa Region

Country

Ukraine

Facility Name

Medical center "Desna" LLC

City

Ternopil'

State/Province

Ternopil' Region

Country

Ukraine

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34719399

Citation

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.

Results Reference

derived

Learn more about this trial

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

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