Restless Legs SyndromePhase 1/2NCT06570941
Benefits of a Cannabidiolic Acid Topical Cream for the Treatment of Restless Leg Syndrome
A Phase 1/2 study testing Chylobinoid Topical Cream in people with Restless Legs Syndrome, run by Synthonics Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- Chylobinoid Topical Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 31 Oct 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Investigate the Benefits of a Cannabidiolic Acid Topical Cream for the Treatment of Restless Leg Syndrome
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:
- Reduce or eliminate the symptoms of restless leg syndrome.
- 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.
Read the 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.
- Conditions
- Restless Legs Syndrome
- Being tested
- Chylobinoid Topical Cream
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chylobinoid Topical CreamDrug
Also called Cannabidiolic acid topical cream
The topical cream is applied to the effected area to reduce or eliminate the symptoms of restless leg syndrome
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Chylobinoid Topical Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Secondary outcomes (1)
Patient Quality of Life in response to treatment
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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start1 Mar 2024
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- therapeutic open label single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Synthonics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570941
- Sponsor's protocol ID
- CHYLORLS-001
- Status last verified
- Aug 2024
- First submitted
- 7 Aug 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Romare, M., et al.
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.
PubMed 18354058Moparthi 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.
PubMed 32717533Fang 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.
PubMed 33422128Allen 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.
PubMed 24051118Piccariello, T., Palmer, S., Mulhare, M.; "Solid Micellar Compositions of Cannabinoid Acids"; International Application No. PCT/US2020/014109, filed January 17, 2020
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Investigate the Benefits of a Cannabidiolic Acid Topical Cream for the Treatment of Restless Leg Syndrome
- ClinicalTrials.gov ID
- NCT06570941
- Acronym / sponsor ID
- CHYLORLS-001
- Conditions
- Restless Legs Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Synthonics IncIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Reduce or eliminate the symptoms of restless leg syndrome.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- therapeutic open label single group
| Arm | Type | Receives |
|---|---|---|
| Benefits of a Cannabidiolic Acid Topical Cream for the Treatment of Restless Leg Syndrome | Experimental | Drug: Chylobinoid Topical CreamTopical of application of cream to effected area 30-45 minutes before bedtime |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chylobinoid Topical CreamAlso: Cannabidiolic acid topical creamThe topical cream is applied to the effected area to reduce or eliminate the symptoms of restless leg syndrome | Drug | Benefits of a Cannabidiolic Acid Topical Cream for the Treatment of Restless Leg Syndrome |
Primary outcome
Change of Restless Leg Syndrome
Time frame: 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.
1 secondary outcome
Patient Quality of Life in response to treatment
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- BackgroundRomare, M., et al.
- Background: PubMed 18354058De 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.
- Background: PubMed 32717533Moparthi 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.
- Background: PubMed 33422128Fang 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.
- Background: PubMed 24051118Allen 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.
- BackgroundPiccariello, T., Palmer, S., Mulhare, M.; "Solid Micellar Compositions of Cannabinoid Acids"; International Application No. PCT/US2020/014109, filed January 17, 2020
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Chylobinoid Topical Cream in people with Restless Legs Syndrome, run by Synthonics Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Restless Leg Syndrome (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06570941, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.