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

August 26, 2024 updated by: Synthonics Inc

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Sarasota, Florida, United States, 34238
        • Synthonics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Benefits of a Cannabidiolic Acid Topical Cream for the Treatment of Restless Leg Syndrome
Topical of application of cream to effected area 30-45 minutes before bedtime
Drug: Chylobinoid Topical Cream
The topical cream is applied to the effected area to reduce or eliminate the symptoms of restless leg syndrome
Other Names:
  • Cannabidiolic acid topical cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Restless Leg Syndrome
Time Frame: 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.
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Quality of Life in response to treatment
Time Frame: 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.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Synthonics Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

August 7, 2024

First Submitted That Met QC Criteria

August 22, 2024

First Posted (Actual)

August 26, 2024

Study Record Updates

Last Update Posted (Actual)

August 28, 2024

Last Update Submitted That Met QC Criteria

August 26, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHYLORLS-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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