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

Phase 1

Withdrawn

• Conditions: octurnal foot and/or leg cramps; Nocturnal foot and/or leg cramps; Musculoskeletal - Normal musculoskeletal and cartilage development and function; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12615001245583
• Lead Sponsor: Flex Pharma, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 80

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.
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).
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.
6.All females, regardless of childbearing potential, must have a negative serum beta human chorionic gonadotropin pregnancy test at Screening and negative serum or urine pregnancy test prior to treatment administration for each study period. Females of childbearing potential (i.e., not postmenopausal or surgically sterile [e.g., tubal ligation, hysterectomy, bi-lateral oophorectomy]) will be required to use a medically acceptable method of contraception starting from Screening throughout the duration of the study. A postmenopausal woman is defined as having spontaneous amenorrhea for at least 1 year with a serum follicle-stimulating hormone (FSH) value consistent with postmenopausal status as per PI judgment. Acceptable methods of contraception include a hormonal or non-hormonal intrauterine device; female condom; diaphragm/cervical cap; contraceptive sponge; a male sexual partner who agrees to use a male condom; a sterile sexual partner; or abstinence (subjects reporting abstinence who become sexually active while on the study must agree to use other additional barrier methods of contraception). The following contraceptive methods are acceptable only when used with an additional barrier method as mentioned above: birth control pills, birth control patches, vaginal ring, hormone under the skin, or hormone injections. Females will refrain from egg donation for the duration of the study.

Participants will be reassessed for eligibility by the Investigator at the end of Period 1, Run in. Participants who in the opinion of the PI do not continue to remain eligible will be removed from the study.

Exclusion Criteria

1.Subjects with established disease/conditions that cause nocturnal leg cramps. These include:
a.Peripheral vascular disease;
b.Lower limb injury;
c.Progressive neuromuscular or neurologic disease;
d.Hemodialysis;
e.Simple muscle strain of lower extremity muscle(s) within the last 4 weeks;
f.Restless leg syndrome;
g.Hypocalcemia;
h.Diabetes.

2.Subjects with periodic limb movement disorders.
3.Subjects with peripheral neuropathy.
4.Subjects with gastroesophageal reflux disease (GERD).
5.Subjects suitable for inclusion in this study are expected to be receiving a variety of concomitant medications to treat other diseases/conditions. Subjects will be excluded if any of their other conditions/diseases are unstable (defined as subjects who have been hospitalized or required changes in their scheduled maintenance medications within the last 4 weeks) or are likely to result in changes in their scheduled maintenance medication (to avoid doubt this includes the addition of new medications or change of dose in an existing medication) or in hospitalization or in their ability to complete and/or participate in the study.
6.Subjects who are receiving statins should not be suffering from any musculo-skeletal adverse/side effects that may be related to this group of drugs.
7.Subjects who in the opinion of the Principal Investigator (PI), should not participate in this study.
8.Subjects who in the opinion of the PI are not able to dial into the IVRS system and complete diaries reliably. Subjects who do not comply with completion requirement to call into the IVRS or complete the diary while on study may be removed from the study at the discretion of the PI and the Sponsor.
9.Subjects that work overnight shifts and sleep during the day.
10. Subjects who have a food allergy to or dislike spicy foods or any the ingredients contained in the Flex-Aid (i.e., capsicum, ginger, and/or cinnamon).
11.History of significant hypersensitivity, intolerance, or allergy to any treatment component, food, or other substance, unless approved by the PI.
12.Individual who consumes more than 14 units of alcohol per week or who has a significant history of alcoholism or drug/chemical abuse within 1 year prior to the Screening (1 unit of alcohol equals 1/2 pint [285 mL] of beer or lager, 1 glass [125 mL] of wine, or 1 ounce [30 mL] of spirits).
13.Use of any drugs of abuse within the past 1 year prior to first treatment on Day 1, Run In, of Period 1 and throughout the duration of the study.
14.Use of any tobacco- or nicotine-containing products within 1 week prior to first treatment on Day 1, Run In, of Period 1 and throughout the duration of the study.
15.Participation in a clinical study within 30 days prior to the first treatment on Day 1, Run In, of Period 1.
16.Subjects who eat pickled or spicy foods or beverages throughout the study (including food containing chili peppers, including Tabasco or other hot sauces, ginger or cinnamon).
17.Injury or surgery to the lower limbs that in the opinion of the PI may impact the study results.
18.Female subjects who are pregnant or lactating.
19. Subjects taking prescription pain medications containing opiates (e.g., hydrocodone, oxycodone, codeine, etc.) or prescription NSAIDs that in the opinion of the PI could affect study results/data interpretation are prohibited from enrolling in the study.
20. Subjects taking gabapentin or related anti-epileptic drugs (AEDs) including bu

Study & Design

• Study Type: Interventional
• Study Design: Not specified