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Cannabinoid
CBD Topical Cream for Restless Legs Syndrome
Phase 1 & 2
Waitlist Available
Research Sponsored by Synthonics Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must meet International Restless Legs Syndrome Study Group (IRLSSG) criteria of at least mild symptoms
Patients with at least 3 month-course of symptomatic restless leg syndrome
Must not have
A need for elective surgery involving preoperative or postoperative analgesics or anesthetics during the study period
Previous operative procedure for treatment of RLS
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test a topical cream for restless leg syndrome. Participants will apply the cream to their legs before bedtime for 14 days to see if it reduces symptoms and improves their quality of life.
Who is the study for?
This trial is for individuals experiencing restless leg syndrome, a condition causing an uncontrollable urge to move the legs. Participants should apply a topical cream before bedtime and can't have skin conditions that might interfere with treatment.
What is being tested?
The study tests if a Cannabidiolic Acid Topical Cream (Chylobinoid) can reduce symptoms of restless leg syndrome and improve life quality when applied nightly over two weeks.
What are the potential side effects?
Potential side effects are not detailed in the provided information. However, as it's a topical cream, common side effects may include skin irritation or allergic reactions at the site of application.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have mild or worse symptoms of restless legs syndrome.
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I have had symptoms of restless leg syndrome for at least 3 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need surgery that requires pain relief before or after the procedure.
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I have had surgery for Restless Leg Syndrome.
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I am not allergic to CBD, CBDa, or ingredients in the cream.
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I haven't used cannabis in the last 2 months and won't use it during the study.
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I am currently using TENS or undergoing plasma exchange.
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I have a history of substance abuse or certain psychiatric conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change of Restless Leg Syndrome
Secondary study objectives
Patient Quality of Life in response to treatment
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Benefits of a Cannabidiolic Acid Topical Cream for the Treatment of Restless Leg SyndromeExperimental Treatment1 Intervention
Topical of application of cream to effected area 30-45 minutes before bedtime
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Who is running the clinical trial?
Synthonics IncLead Sponsor