NCT06570941

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

A Pilot Study to Investigate the Benefits of a Cannabidiolic Acid Topical Cream for the Treatment of Restless Leg Syndrome

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Synthonics Inc · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	Chylobinoid Topical Cream	The topical cream is applied to the effected area to reduce or eliminate the symptoms of restless leg syndrome

Timeline

• Start date: 2024-03-01
• Primary completion: 2024-09-30
• Completion: 2024-10-31
• First posted: 2024-08-26
• Last updated: 2024-08-28

Locations

1 site across 1 country: United States