Benefits of a Cannabidiolic Acid Topical Cream for the Treatment of Restless Leg Syndrome

Summary

The goal of this open label clinical trial is to reduce the effects of restless leg syndrome. The main it questions it aims to answer are: 1. Reduce or eliminate the symptoms of restless leg syndrome. 2. Improve the quality of life of participants with restless leg syndrome. Participants will be asked to apply the topical cream to the affected area 30 to 45 minutes before bedtime for 14 consecutive days.

Timeline

Start

2024-03-01

Primary completion

2024-09-30

Completion

2024-10-31

Publications

• Background Romare, M., et al.
• Background De Petrocellis L, Vellani V, Schiano-Moriello A, Marini P, Magherini PC, Orlando P, Di Marzo V. Plant-derived cannabinoids modulate the activity of transient receptor potential channels of ankyrin type-1 and melastatin type-8. J Pharmacol Exp Ther. 2008 Jun;325(3):1007-15. doi: 10.1124/jpet.107.134809. Epub 2008 Mar 19.
• Background Moparthi L, Zygmunt PM. Human TRPA1 is an inherently mechanosensitive bilayer-gated ion channel. Cell Calcium. 2020 Nov;91:102255. doi: 10.1016/j.ceca.2020.102255. Epub 2020 Jul 18.
• Background Fang XZ, Zhou T, Xu JQ, Wang YX, Sun MM, He YJ, Pan SW, Xiong W, Peng ZK, Gao XH, Shang Y. Structure, kinetic properties and biological function of mechanosensitive Piezo channels. Cell Biosci. 2021 Jan 9;11(1):13. doi: 10.1186/s13578-020-00522-z.
• Background Allen RP. Minimal clinically significant change for the International Restless Legs Syndrome Study Group rating scale in clinical trials is a score of 3. Sleep Med. 2013 Nov;14(11):1229. doi: 10.1016/j.sleep.2013.08.001. Epub 2013 Aug 14. No abstract available.
• Background Piccariello, T., Palmer, S., Mulhare, M.; "Solid Micellar Compositions of Cannabinoid Acids"; International Application No. PCT/US2020/014109, filed January 17, 2020

Drugs

Indications