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New treatment option for Restless Leg Syndrome (RLS)
Official title Using Cannabis to Treat Restless Legs Syndrome
ClinicalTrials.gov ID: NCT06863740
What this study is testing
What is Cannabis oil?
Cannabis oil is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for restless leg syndrome (rls).
Also referred to as MPL-005.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Restless Legs Syndrome (RLS) is a disorder that causes painful and uncomfortable sensations in the legs, and its symptoms have a significant impact on sleep and quality of life. Cannabis has been used by some RLS patients as a treatment due to its painkilling and drowsiness effects, however there has never been a clinical research trial investigating cannabis in patients with RLS.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 and older
You may be able to join if
- ≥25 years of age
- diagnosis of RLS based on the International RLS Study Group criteria
- refractory RLS symptoms despite use of dopaminergic and/or alpha-2-delta ligand therapy
- onset of RLS at least 6 months before screening
You likely can't join if
- sleep disordered breathing, or sleep disordered breathing that is not adequately controlled on therapy (apnea-hypopnea index of \>15)
- cannabis use within 4 weeks of study enrollment
- known allergy to cannabis, cannabinoids or palm/coconut oil
- Currently pregnant or breast-feeding (a negative urine pregnancy test must be obtained for women of childbearing potential during pretreatment...
- Active substance abuse
- Ischemic heart disease with unstable angina or recent acute coronary syndrome in the last 3 months, uncontrolled arrhythmias, poorly controlled...
See the full eligibility criteria
- ≥25 years of age
- diagnosis of RLS based on the International RLS Study Group criteria
- refractory RLS symptoms despite use of dopaminergic and/or alpha-2-delta ligand therapy
- onset of RLS at least 6 months before screening
- sleep disordered breathing, or sleep disordered breathing that is not adequately controlled on therapy (apnea-hypopnea index of \>15)
- cannabis use within 4 weeks of study enrollment
- known allergy to cannabis, cannabinoids or palm/coconut oil
- Currently pregnant or breast-feeding (a negative urine pregnancy test must be obtained for women of childbearing potential during pretreatment evaluation)
- Active substance abuse
- Ischemic heart disease with unstable angina or recent acute coronary syndrome in the last 3 months, uncontrolled arrhythmias, poorly controlled hypertension
- Serious liver disease
- History of schizophrenia or any other psychotic disorder
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 25 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.