Clinical trial NCT06570941: Benefits of a Cannabidiolic Acid Topical Cream for the Treatment of Restless Leg Syndrome
Official title: A Pilot Study to Investigate the Benefits of a Cannabidiolic Acid Topical Cream for the Treatment of Restless Leg Syndrome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Restless Legs Syndrome
Lead sponsor: Synthonics Inc
Sponsor class: INDUSTRY
First posted: 2024-08-26
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: therapeutic open label single group
Primary purpose: TREATMENT

Brief 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.

Detailed description: Restless Leg Syndrome (RLS) is multifactorial disease state with many different potential pathophysiological mechanisms, which includes dysfunctions from the cerebral cortex and spinal cord to mechanosensitive channels at the musculoskeletal periphery.1 Most therapeutic agents' effectiveness focuses on the CNS (e.g., dopaminergic drugs) or Renshaw cells. To our knowledge, therapeutic agents that are focused on the periphery were not very effective.

This technology focuses on the peripheral musculoskeletal component of the disease and is directed at treatment modalities that correct the dysfunction of mechanosensitive channels. By combining what is known about cannabinoids activity at the transient receptor potential channel of ankyrin 1 (TRPA1)2 and the role TRPA1 plays in regulating the shape and rigidity of the surrounding membrane structure at the Piezo channels3, an effective therapy at the site of discomfort should emerge. Moreover, the lessening of membrane tension is imparted by molecules that readily penetrate the membrane4, which Chylobinoid, the topical active ingredient, is uniquely designed to do.

Eligibility criteria: Inclusion Criteria:

* Patients with at least 3 month-course of symptomatic restless leg syndrome
* Must meet International Restless Legs Syndrome Study Group (IRLSSG) criteria of at least mild symptoms.
* Age \> 18 years, including both males and females
* Patient provides informed consent

Exclusion Criteria:

* Previous operative procedure for treatment of RLS;
* Current use of TENS (transcutaneous electrical nerve stimulation or plasma exchange;
* Allergy to Cannabidiol (CBD) Cannabidiolic acid (CBDa), or any other ingredient contained in the topical cream;
* Pregnant participants (participants who have the potential for being pregnant will sign a waiver), or breast feeding;
* History of recreational substance abuse, fibromyalgia, Chronic Regional Pain Syndrome (CRPS), psychiatric history including but not limited to schizoaffective disorder, bipolar disorder, chronic depression, and suicidal ideation;
* Conditions affecting capacity and adherence to study regimen including but not limited to dementia/delirium, Alzheimer's, Down's syndrome;
* A need for elective surgery involving preoperative or postoperative analgesics or anesthetics during the study period;
* No recent cannabinoid use in the last 2 months, and no use during the study.

Primary outcomes:
measure: Change of Restless Leg Syndrome
timeFrame: 14 days
Secondary outcomes:
measure: Patient Quality of Life in response to treatment
timeFrame: 14 days
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: Synthonics
state: Florida
Study officials:
References:
citation: Romare, M., et al.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Piccariello, T., Palmer, S., Mulhare, M.; "Solid Micellar Compositions of Cannabinoid Acids"; International Application No. PCT/US2020/014109, filed January 17, 2020