A Phase 2 interventional study of Cannabis oil vs placebo in Multiple Sclerosis, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Recruiting at 1 site in Canada. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2024-12-13.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Phase 2, Interventional, and Treatment
Multiple sclerosis (MS) is an inflammatory disease of the central nervous system (CNS) afflicting over 77,000 Canadians. Unfortunately, the therapeutic arsenal to relieve MS symptoms is limited. It is therefore essential to develop better approaches to treat the symptoms of MS. The use of cannabis for recreational purposes is now legal in Canada. However, for many years, people with Multiple Sclerosis (PwMS) have used cannabis either to relax, to reduce pain and spasticity, or to improve sleep and daily functioning. Currently, there is little scientifically established evidence that cannabis works on these symptoms in people with MS. It is therefore important to carry out studies to better understand the efficacy Δ-9-tetrahydrocannabinol (THC), and cannabidiol (CBD) on MS symptoms . THC is known for its analgesic, neuroprotective and anti-inflammatory properties and CBD seems to have positive effects on anxiety and cognitive abilities (memory, concentration).
For this study, investigators hypothesize that administering different doses of THC alone, CBD alone, and THC and CBD combined will result in a significant beneficial effect on spasticity relief compared to placebo.
The aim of this study is to document,
Participants will initially receive THC 4mg/day or CBD 40mg/day or THC/CBD combination (THC 4mg and CBD 40mg/day), or placebo, on the first day. Dose will be increased up to 20mg (THC) and 200mg (CBD) per day, if well tolerated. Participants will receive the allocated treatment for a total of 4 weeks, followed by an additional 12 weeks of treatment for responders who will be identified as patients who had a decrease from baseline in spasticity of at least one point on the Numerical Rating Scale . THC and CBD will be taken as oil softgels in two divided doses per day. Cannabis extract and placebo will taste and look exactly the same.
To protect from all contingencies and to minimize the risk of adverse reactions, the presence of adverse events will be evaluated at each research visit, as well as through courtesy calls between visits. If any mental or physical symptoms occur that require medical attention, the PwMS will be referred as required to an attending neurologist, psychiatrist, or other specialists .
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's planned enrollment of 250 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 370 studies on the registry; 110 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants must meet the following criteria:
Exclusion Criteria:
Participants will be excluded if any of the following criteria are met:
* Dosage form : Softgel * Dosage \& frequency : 40 mg /day of CBD up to 200 mg in two doses a day * Duration : 4 weeks of treatment followed by 12 additional weeks of follow up.
Drug: Cannabis oil vs placebo
* Dosage form : Softgel * Dosage \& frequency : 4 mg /day of THC up to 20 mg in two doses a day * Duration : 4 weeks of treatment followed by 12 additional weeks of follow up.
Drug: Cannabis oil vs placebo
* Dosage form : Softgel * Dosage \& frequency : 40 mg /day of CBD up to 200 mg and 4 mg /day of THC up to 20 mg in two doses a day * Duration : 4 weeks of treatment followed by 12 additional weeks of follow up.
Drug: Cannabis oil vs placebo
* Dosage form : Softgel * Dosage \& frequency : caps of placebo twice a day * Duration : 4 weeks of treatment followed by 12 additional weeks of follow up.
Drug: Cannabis oil vs placebo
Eligibility, Screening and Baseline (T0): Candidates will be seen by both research staff and a neurologist. Full written informed consent will be obtained before completing questionnaires and administering physical and medical evaluations. If eligibility is confirmed, a blood sample will be collected followed by participant randomisation . Follow-up visits: Randomized participants come back after 4 weeks (T1) for the same assessments administered at T0. Only participants who had a decrease in their level of spasticity can continue their participation in the same allocated arm for an additional period of 12 weeks. At the end of the additional period of 12 weeks (T2), another visit is scheduled for a last assessments which are the same as T0 and T1. Throughout study, courtesy calls will be scheduled and standard care for MS will also be offered to ensure participants 'safety and well-being.
Also known as: Randomized Controlled Trial
Spasticity patient reported change assessment
Patient-reported spasticity: a Numerical rating scale - 0 (No pain) to 10 (worst pain)
Time frame: Change from Baseline Patient reported spasticity at 28 weeks and 16 weeks
Spasticity change Clinician assessment
Spasticity: Ashworth scale -1 (normal) to 4 (rigid)
Time frame: Change from Baseline Clinician evaluation spasticity at 28 weeks and 16 weeks
Pain change assessment
Pain: Pain Effects-1 (Not at all) to 4 (extreme)
Time frame: Change from Baseline pain at 28 weeks and 16 weeks
Mobility Change assessement
Mobility: Timed 25-Foot Walk test
Time frame: Change from Baseline mobility at 28 weeks and 16 weeks
Fatigue change assessement
Fatigue: Modified Fatigue Impact Scale-0 (never) to 4 (always)
Time frame: Change from Baseline fatigue at 28 weeks and 16 weeks
Sleep change assessement
Sleep: Pittsburgh Study Quality sleep Index-0 (no difficult) to 3 (severe)
Time frame: Change from Baseline sleep at 28 weeks and 16 weeks
Drowsiness change assessement
Drowsiness: Epworth Sleepiness scale-0 (no chance) to 3 (High chance)
Time frame: Change from Baseline Drowsiness at 28 weeks and 16 weeks
Bowel /Bladder dysfunction change assessement
Bowel /Bladder dysfunction: Bowel/Bladder Control Scale-0 (not at all) to 4 (Daily)
Time frame: Change from Baseline Bowel/Bladder dysfunction at 28 weeks and 16 weeks
Sexual dysfunction change assessement
Sexual dysfunction: Sexual Satisfaction Scale-0 (Extremely Satisfied) to 6 (Extremely Dissatisfied)
Time frame: Change from Baseline Sexual dysfunction at 28 weeks and 16 weeks
Restless Legs Syndrome change assessement
Restless Legs Syndrome - 4 (V.severe) to 0 (None)
Time frame: Change from Baseline Restless Legs Syndrome at 28 weeks and 16 weeks
Mental Health disorder change assessement
Mental Health issues: Mental Health inventory-1 (All of the time) to 6 (None of the time)
Time frame: Change from Baseline Mental Health at 28 weeks and 16 weeks
Anxiety/Depression change assessement
Anxiety/Depression: Hospital Anxiety and Depression-0 to 3 (highest level)
Time frame: Change from Baseline Anxiety/Depression at 28 weeks and 16 weeks
Cannabis use disorder assesssment
Cannabis use disorder : diagnosis
Time frame: Cannabis use disorder : assessment at only baseline
Cognition change assessement
Cognition tests
Time frame: Change from Baseline cognition at 28 weeks and 16 weeks
Quality of life change assessement
Quality of life: Health Status Questionnaire (Higher scores indicate better health)
Time frame: Change from Baseline Quality of life at 28 weeks and 16 weeks
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Centre hospitalier de l'Université de Montréal (CHUM)