Efficacy/tolerability of Flex-Aid in subjects with night leg cramps
Research type
Research Study
Full title
A RANDOMIZED, CROSS-OVER DESIGN STUDY TO EVALUATE THE EFFICACY AND TOLERABILITY OF FLEX AID IN SUBJECTS WITH NOCTURNAL FOOT AND/OR LEG CRAMPS
IRAS ID
165919
Contact name
Tim Hall
Contact email
Sponsor organisation
Flex Pharma, Inc.
Duration of Study in the UK
0 years, 8 months, 29 days
Research summary
New research has shown that muscle cramps and spasms are usually not due to dehydration or electrolyte imbalance and do not originate in the muscle itself but are actually caused by a neural mechanism in the spinal cord that control muscle contraction. Flex Pharma hypothesizes, that capsicum(an extract from the hot peppers) can relieve the muscle cramps by stimulating receptors in the mouth, esophagus and guts which trigger impulses up-regulating the nerve cells in the spinal cord responsible for the muscle contractions, that way relieving the cramps. Flex Pharma developed Flex-Aid beverage to test the hypothesis that it can relieve the muscle cramps. The study will begin with a screening visit to check eligibility and will continue with 3 study periods. Period 1 is 14-day, single-blind run-in period to remove potential placebo responders. Eligible subjects will then be randomized in a 1:1 ratio to receive Flex-Aid or Placebo beverage in cross-over Periods 2 and 3 lasting 14 days each. Subjects will be dispensed study medication/placebo and will self-administer their assigned treatment and complete the study diary in each period. Approximately eighty (80) male and female subjects may be enrolled into Period 1 so that approximately 48 eligible subjects will continue on to cross-over Periods 2 and 3 to achieve 40 subjects to complete the study.
The Flex-Aid beverage contains three ingredients defined as spices: capsicum, ginger and cinnamon extracts.REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
14/SW/1149
Date of REC Opinion
3 Dec 2014
REC opinion
Unfavourable Opinion