Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570941
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
Benefits of a Cannabidiolic Acid Topical Cream for the Treatment of Restless Leg Syndrome
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Pilot Study to Investigate the Benefits of a Cannabidiolic Acid Topical Cream for the Treatment of Restless Leg Syndrome
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 periphery1 Most therapeutic agents effectiveness focuses on the CNS eg 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 TRPA12 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
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 TRPA12 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None