Clinical trial NCT03807219: 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
Overall status: COMPLETED
Phase: NA
Conditions: Nocturnal Leg Cramps
Keywords: nocturnal legs cramps
legs cramps
NLC
Lead sponsor: Naveh Pharma LTD
Sponsor class: INDUSTRY
First posted: 2019-01-16
Enrollment: 216
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: The number of episodes of NLC
timeFrame: 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 outcomes:
measure: Duration of NLC
timeFrame: 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.
measure: Severity of pain associated with NLC
timeFrame: 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.
measure: Change in quality of life (SF-36)
timeFrame: 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.
measure: Changing in the sleep quality
timeFrame: 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.
measure: Drop-out rate
timeFrame: 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.
Other outcomes:
Locations:
city: Kharkiv
country: Ukraine
facility: Kharkiv City Clinic №9
state: Kharkiv Region
city: Kyiv
country: Ukraine
facility: Kyiv city clinic №9
state: Kyiv Region
city: Kyiv
country: Ukraine
facility: Medical Center "Artem"
state: Kyiv Region
city: Kyiv
country: Ukraine
facility: Medical Center "Preventclinic" LLC
state: Kyiv Region
city: Lviv
country: Ukraine
facility: City clinic №5
state: Lviv Region
city: Odesa
country: Ukraine
facility: Odesa Railway City Clinic
state: Odesa Region
city: Ternopil'
country: Ukraine
facility: Medical center "Desna" LLC
state: Ternopil' Region
Study officials:
affiliation: Naveh Pharma LTD
name: Nitsan Primor
role: STUDY_DIRECTOR
References:
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.