Restless Leg Syndrome (RLS)NCT06863740
Using Cannabis to Treat Restless Legs Syndrome
A study testing Cannabis oil in people with Restless Leg Syndrome (RLS), run by Sunnybrook Health Sciences Centre at 2 sites in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Restless Leg Syndrome (RLS)
- What is being tested?
- Cannabis oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesCanada
- Study dates
- 25 Jul 2025to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5
Mark Boulos, MD, 416-480-4473, mark.boulos@sunnybrook.ca
- Recruiting
University Health Network
Toronto, Ontario, M5G 2C4
Hance Clarke, MD, 416-340-5164, Hance.Clarke@uhn.ca
About this study
Official title: Using Cannabis to Treat Restless Legs Syndrome: A Randomized Placebo Controlled Pilot Safety and Feasibility Trial
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. A controlled trial is needed to establish how safe and feasible cannabis is as a treatment for RLS. The investigators plan to randomize 30 participants with moderate-to-severe RLS to receive either cannabis or placebo for 8 weeks. The investigators will measure patients sleep quality and quality of life at baseline and 8-week follow-up. The investigators will also monitor patients for any adverse reactions to the study drug.
- Conditions
- Restless Leg Syndrome (RLS)
- Being tested
- Cannabis oil, Cannabis placebo
- 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.
Cannabis oilDrug
Also called MPL-005
5:1 CBD:THC oral formulation with a concentration of 25 mg/g CBD and 5 mg/g THC in a pharmaceutical grade medium chain triglyceride (MCT) oil.
Cannabis placeboDrug
Placebo oil
| Study group | Role | What they receive |
|---|---|---|
| Cannabis Arm | Experimental | 5:1 CBD:THC oral cannabis Receives: Drug: Cannabis oil |
| Placebo Arm | Placebo comparator | Oral placebo Receives: Drug: Cannabis placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events and Serious Adverse Events
We will measure the rate and type of treatment related adverse events
Measured: 8 weeks
Rate of Study Completion
The percentage of enrolled participants who complete the study
Measured: 8 weeks
Secondary outcomes (9)
Change from Baseline in Restless Legs Syndrome Quality of Life (RLSQoL) at 8 Weeks
The Summary Score of the RLSQoL will be calculated, ranging from 0 (worse quality of life) to 100 (best quality of life).
Measured: 8 weeks
Change from Baseline in Self-Reported Quality of Life on the Short Form-36 (SF-36) Health Survey Questionnaire at 8 Weeks
The SF-36 Questionnaire has 36-items that covers eight areas: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Scores for each domain range from 0 to 100, with a higher score indicating better health.
Measured: 8 weeks
Change in Restless Legs Syndrome Severity using the International RLS Study Group Rating Scale from Baseline to Follow-up
The International RLS Study Group Rating Scale measures RLS severity based on the following summary scale:
Very severe=31-40 points Severe=21-30 points Moderate=11-20 points Mild=1-10 points None=0 points
Measured: 8 weeks
Change in Sleep Quality as assessed by the Pittsburgh Sleep Quality Index from Baseline to Follow-Up
Sleep quality as assessed by the Pittsburgh Sleep Quality Index. The questionnaire is scored on a range from 0-21 points, with "0" indicating no difficulty and "21" indicating severe difficulties in all areas.
Measured: 8 weeks
Change in Daytime Sleepiness as assessed by the Epworth Sleepiness Scale from Baseline to Follow-Up
Scores on Epworth Sleepiness Scale range from range from 0 to 24, with higher scores indicating higher average sleep propensity in daily life (daytime sleepiness).
Measured: 8 weeks
Change in Mood as assessed by the Beck Depression Inventory from Baseline to Follow-Up
The Beck Depression Inventory has 21 questions that are scored on a range of 0-63 points. Higher scores indicate more severe depression.
Measured: 8 weeks
Change in Objective Sleep Quality as Measured by Actigraphy from Baseline to Follow-Up
Objective sleep quality will be assessed using wrist actigraphy that will be provided with the home sleep apnea test. Sleep efficiency will be calculated by dividing the amount of time spent asleep (in minutes) by the total amount of time in bed (in minutes).
Measured: 8 weeks
Change in Leg Movements as Measured by Ankle Actigraphy from Baseline to Follow-Up
Ankle actigraphy will be used to count the number of leg movements that occur throughout the night.
Measured: 8 weeks
Change in Obstructive Sleep Apnea (OSA) Severity (as measured by the apnea-hypopnea index) from Baseline to Follow-Up
Measured by the apnea-hypopnea index (AHI). AHI quantifies the number of apneas and hypopneas per hour of sleep. It will be measured using a home sleep monitor or a readout from a continuous positive airway pressure (CPAP) machine.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start25 Jul 2025
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Leg Syndrome (RLS)Studies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863740
- Sponsor's protocol ID
- 4752
- Status last verified
- Apr 2026
- First submitted
- 3 Mar 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Cannabis to Treat Restless Legs Syndrome: A Randomized Placebo Controlled Pilot Safety and Feasibility Trial
- ClinicalTrials.gov ID
- NCT06863740
- Acronym / sponsor ID
- 4752
- Conditions
- Restless Leg Syndrome (RLS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- University Health Network, Toronto
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 7 Mar 2025 (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.
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. A controlled trial is needed to establish how safe and feasible cannabis is as a treatment for RLS. The investigators plan to randomize 30 participants with moderate-to-severe RLS to receive either cannabis or placebo for 8 weeks. The investigators will measure patients sleep quality and quality of life at baseline and 8-week follow-up. The investigators will also monitor patients for any adverse reactions to the study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannabis Arm | Experimental | Drug: Cannabis oil5:1 CBD:THC oral cannabis |
| Placebo Arm | Placebo comparator | Drug: Cannabis placeboOral placebo |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Cannabis oilAlso: MPL-0055:1 CBD:THC oral formulation with a concentration of 25 mg/g CBD and 5 mg/g THC in a pharmaceutical grade medium chain triglyceride (MCT) oil. | Drug | Cannabis Arm |
| Cannabis placeboPlacebo oil | Drug | Placebo Arm |
Primary outcome
Incidence of Adverse Events and Serious Adverse Events
Time frame: 8 weeks
We will measure the rate and type of treatment related adverse events
Rate of Study Completion
Time frame: 8 weeks
The percentage of enrolled participants who complete the study
9 secondary outcomes
Change from Baseline in Restless Legs Syndrome Quality of Life (RLSQoL) at 8 Weeks
Time frame: 8 weeks
Change from Baseline in Self-Reported Quality of Life on the Short Form-36 (SF-36) Health Survey Questionnaire at 8 Weeks
Time frame: 8 weeks
Change in Restless Legs Syndrome Severity using the International RLS Study Group Rating Scale from Baseline to Follow-up
Time frame: 8 weeks
Change in Sleep Quality as assessed by the Pittsburgh Sleep Quality Index from Baseline to Follow-Up
Time frame: 8 weeks
Change in Daytime Sleepiness as assessed by the Epworth Sleepiness Scale from Baseline to Follow-Up
Time frame: 8 weeks
Change in Mood as assessed by the Beck Depression Inventory from Baseline to Follow-Up
Time frame: 8 weeks
Change in Objective Sleep Quality as Measured by Actigraphy from Baseline to Follow-Up
Time frame: 8 weeks
Change in Leg Movements as Measured by Ankle Actigraphy from Baseline to Follow-Up
Time frame: 8 weeks
Change in Obstructive Sleep Apnea (OSA) Severity (as measured by the apnea-hypopnea index) from Baseline to Follow-Up
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cannabis oil in people with Restless Leg Syndrome (RLS), run by Sunnybrook Health Sciences Centre at 2 sites in Canada.
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: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark Boulos, MD (416-480-4473, mark.boulos@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events and Serious Adverse Events (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2026.