A trial to evaluate the effect of Flex-Aid beverage on frequency of nocturnal foot and/or leg cramps and its safety and tolerability

INTERVENTION: As per below: there is no washout period between the end of period 1 and start of period 2. In this study participants will receive three treatments, Treatment 1 (capsule), Treatment 2 (beverage) and Treatment 3 (beverage) to test the effect of Flex‐Aid on stopping or reducing the night‐time muscle cramps. Each treatment will be taken by mouth at home each night approximately 45 minutes before bedtime over 3 periods of time lasting 14 days each. Each treatment may include a combination any of the following ingredients: *Ginger extract (up to 750mg) *Cinnamon extract (up to 500mg) *Capsicum extract (ingredient in hot peppers, up to 38mg) *8.3 grams of sugar from corn syrup *Sugar *Red food colouring Treatment 2 and 3 (beverages) may smell like cinnamon, be the colour of soda and taste similar to atomic fireball candy or be very sweet. They may also be very hot and spicy. Participants will be assigned by chance (like flipping a coin ‐ random selection) to the order that they will receive the study treatments. Participants will be asked to take Treatment 1 (capsule), Treatment 2 or 3 (about 1/4 cup) up to 42 times during the study. Approximately eighty (80) male and female subjects will be enrolled into the Run‐in Phase of Period 1. Period 1 consists of two parts as follows: Part 1 is a 7‐day washout phase where subjects washout of existing treatments for nocturnal muscle cramps. Only subjects on treatments for leg cramps will be enrolled in the washout phase, Part 2 is a 14 day single blind phase where subjects will self administer treatment 1 each day for 14 days. Approximately 48 eligible subjects who meet eligibility criteria will continue on to cross‐over Periods 2 and 3 to achieve 40 subjects to complete the study (Treatments 2 & 3). Treatments 2 or 3 will be taken once every night for 14 days during Period 2; and the alternative treatment 2 or 3 once every night for 14 days during period 3. Eligible subjects will be randomized in a 1:1 ratio in cross‐over periods 2 and 3. Please note there is no wash‐out period between treatments 2 and 3. Subjects will be provided all the necessary supplies and instructions for drug preparation as required at the scheduled study visit between Periods 2 and 3 (14 to 17 days). Treatments 2 and 3 occur consecutively. The PI will appoint a qualified member of the study team to make telephone contact with each subject on Day 7 +/‐ 2 days in each study period to assess adherence to intervention protocols by asking the subject to indicate (and provide details concerning) whether or not the investigational product was consumed each night at the appropriate time during the preceding interval. Missed or inappropriately timed doses will be recorded. Subjects will also be asked to complete a daily study diary that includes time and date of dosing. CONDITION: Nocturnal foot and/or leg cramps PRIMARY OUTCOME: No. of reported SAEs and unexpected AEs ; ; Known AE's include: temporal headache, dizziness and flatulence. These AE's were considered probably related to Flex‐Aid. ; ; AE's will be noted in the patient diaries and captured during the study visits at each timepoint. Treatment difference (Flex Aid ‐ Inactive treatment) in mean number of cramps/14 day period ; ; This outcome will be assessed using: ; Daily diary including a VAS scale that will measure the pain/intensity of the foot and/or leg cramps; Quality of Life Questionnaire (SF36); Sleep survey and CGI scale. 2. Subjects greater than or equal to 50 years of age at screening. 3. Negative urine drug and alcohol results at Screening and throughout the study. 4. Negative results at Screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) and hepatitis C virus (HCV). SECONDARY OUTCOME: Change from baseline in QOL SF‐36 assessments Change from baseline in VAS pain/intensity assessments Change in severity of night/leg foot cramps from baseline in CGI scale Change in sleeping difficulty from baseline in Insomnia Severity Index assessments INCLUSION CRITERIA: 1. Male or female subjects who self‐report having four (4) or more nights with at least one nocturnal‐time leg and/or foot cramp within the last 4 weeks prior to Screening. 5. Males will either be surgically sterile or agree to use, through the duration of the study, one of the following approved methods of contraception: a male condom; a surgically sterile sexual partner; use of an intrauterine device by female sexual partner; a female condom; contraceptive sponge; a diaphragm; a cervical cap; an intravaginal system or oral, implantable, transdermal, or injectable contraceptives. Males will refrain from sperm donation throughout the duration of the study.

Epistemonikos ID: 9a467fd0b19ee8eb1c82d622aac890da7127f5ac
First added on: Aug 23, 2024