Status:
ACTIVE_NOT_RECRUITING
Benefits of a Cannabidiolic Acid Topical Cream for the Treatment of Restless Leg Syndrome
Lead Sponsor:
Synthonics Inc
Conditions:
Restless Legs Syndrome
Eligibility:
All Genders
21+ years
Phase:
PHASE1
PHASE2
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...
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 mechano...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06570941
Start Date
March 1 2024
End Date
October 31 2024
Last Update
August 28 2024
Active Locations (1)
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1
Synthonics
Sarasota, Florida, United States, 34238