Using Cannabis to Treat Restless Legs Syndrome

NCT06863740 | Recruiting

• 1 other identifier: 4752
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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 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)

Outcome Measures

Primary Outcomes (2)

• Incidence of Adverse Events and Serious Adverse Events

  We will measure the rate and type of treatment related adverse events

  8 weeks

• Rate of Study Completion

  The percentage of enrolled participants who complete the study

  8 weeks

Secondary Outcomes (9)

• Change from Baseline in Restless Legs Syndrome Quality of Life (RLSQoL) at 8 Weeks

  8 weeks

• Change from Baseline in Self-Reported Quality of Life on the Short Form-36 (SF-36) Health Survey Questionnaire at 8 Weeks

  8 weeks

• Change in Restless Legs Syndrome Severity using the International RLS Study Group Rating Scale from Baseline to Follow-up

  8 weeks

• Change in Sleep Quality as assessed by the Pittsburgh Sleep Quality Index from Baseline to Follow-Up

  8 weeks

• Change in Daytime Sleepiness as assessed by the Epworth Sleepiness Scale from Baseline to Follow-Up

  8 weeks

Study Arms (2)

Cannabis Arm

EXPERIMENTAL

5:1 CBD:THC oral cannabis

Drug: Cannabis oil

Placebo Arm

PLACEBO COMPARATOR

Oral placebo

Drug: Cannabis placebo

Interventions

Cannabis oil DRUG

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.

Also known as: MPL-005

Cannabis Arm

Cannabis placebo DRUG

Placebo oil

Placebo Arm

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• University Health Network, Toronto: collaborator

Study Sites (2)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

RECRUITING

University Health Network

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Central Study Contacts

Mark Boulos, MD

CONTACT

416-480-4473; mark.boulos@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: July 25, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)