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

Phase 1

Active, not recruiting

• Conditions: Restless Legs Syndrome
• Interventions: Drug: Chylobinoid Topical Cream

• Registration Number: NCT06570941
• Lead Sponsor: Synthonics Inc

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.

Study Timeline

• Study Start: 2024-03-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-07
• Study First Submitted QC: 2024-08-22
• Study First Posted: 2024-08-26
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-28
• Primary Completion: 2024-09-30
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Benefits of a Cannabidiolic Acid Topical Cream for the Treatment of Restless Leg Syndrome	Chylobinoid Topical Cream	Topical of application of cream to effected area 30-45 minutes before bedtime

Primary Outcome Measures

Name	Time	Method
Change of Restless Leg Syndrome	14 days	Severity of restless leg syndrome will be measured using the international restless leg syndrome questionnaire. It is a 10 question scale that is scored from 0 to 5 with 4 representing the most severe symptoms and 0 representing the least.

Secondary Outcome Measures

Name	Time	Method
Patient Quality of Life in response to treatment	14 days	Change measured by Patients' Global Impression of Change scale (PGIC). The scale is 3 to -2 with 3 being much improved and -2 being much worse.

Trial Locations

Locations (1)

Synthonics; 🇺🇸 Sarasota, Florida, United States