Restless Legs Syndrome
Conditions
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.
Interventions
DRUGChylobinoid Topical Cream
The topical cream is applied to the effected area to reduce or eliminate the symptoms of restless leg syndrome
Sponsors
Synthonics Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
therapeutic open label single group
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed