Health TrialsbyHealthPanel

Using Cannabis to Treat Restless Legs Syndrome

ConditionRestless Leg Syndrome (RLS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25+
SponsorSunnybrook Health Sciences Centre

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Cannabis placebo

    Drug

    Placebo oil

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Cannabis ArmExperimental treatment 1 intervention
Group B: Placebo ArmPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Adverse Events and Serious Adverse Events

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

Time frame
8 weeks
2

Rate of Study Completion

The percentage of enrolled participants who complete the study

Time frame
8 weeks

Secondary outcomes

1

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).

Time frame
8 weeks
2

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.

Time frame
8 weeks
3

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

Time frame
8 weeks
4

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.

Time frame
8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sunnybrook Health Sciences Centre

Lead sponsor

University Health Network, Toronto

Collaborator

Source ClinicalTrials.gov
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