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

NCT06570941 | Active Not Recruiting Phase 1

• 1 other identifier: CHYLORLS-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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. 1.Reduce or eliminate the symptoms of restless leg syndrome.
2. 2.Improve the quality of life of participants with restless leg syndrome.

Conditions

Restless Legs Syndrome

Outcome Measures

Primary Outcomes (1)

• Change of Restless Leg Syndrome

  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 Outcomes (1)

• Patient Quality of Life in response to treatment

  14 days

Study Arms (1)

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

EXPERIMENTAL

Topical of application of cream to effected area 30-45 minutes before bedtime

Drug: Chylobinoid Topical Cream

Interventions

Chylobinoid Topical Cream DRUG

The topical cream is applied to the effected area to reduce or eliminate the symptoms of restless leg syndrome

Also known as: Cannabidiolic acid topical cream

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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Synthonics Inc: lead

Study Sites (1)

Synthonics

Sarasota, Florida, 34238, United States

Location

Related Publications (6)

• 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.

  PMID: 18354058 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.

  PMID: 32717533 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.

  PMID: 33422128 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.

  PMID: 24051118 BACKGROUND

• Piccariello, T., Palmer, S., Mulhare, M.; "Solid Micellar Compositions of Cannabinoid Acids"; International Application No. PCT/US2020/014109, filed January 17, 2020

  BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Restless Legs Syndrome

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: therapeutic open label single group

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 26, 2024
• Study Start: March 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: October 31, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)