Using cannabis to help treat symptoms of multiple sclerosis

Efficacy of Cannabinoids to the Current Standard Treatments on Symptom Relief in Persons With Multiple Sclerosis: Randomized Controlled Trial

This study is testing if cannabis products, like THC and CBD, can help people with multiple sclerosis manage their symptoms better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) (Academic / other)
• Locations: 1 site (Montreal, Quebec)
• Trial ID: NCT05092191 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy of THC and CBD, both separately and in combination, as complementary therapies for managing spasticity and other symptoms in patients with multiple sclerosis (MS). Participants will receive either THC, CBD, a combination of both, or a placebo for a total of 16 weeks, with dose adjustments based on tolerability. The study aims to assess not only the effectiveness of these treatments but also their tolerability and the underlying mechanisms of their effects. Regular evaluations will be conducted to monitor adverse events and ensure participant safety.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 and older with a confirmed diagnosis of multiple sclerosis and significant spasticity not relieved by current therapies.

Not a fit: Patients with other conditions causing spasticity or those who have recently received botulinum toxin injections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new therapeutic option for patients with multiple sclerosis to alleviate their symptoms.

How similar studies have performed: While there is limited scientific evidence on the efficacy of cannabis for MS symptoms, this study aims to fill that gap and could provide valuable insights into its therapeutic potential.

Eligibility criteria

Inclusion Criteria:

Participants must meet the following criteria:

1. Diagnosed with MS (any subtype), for at least six months, by a MS neurologist, according to the recent version of the McDonald criteria;
2. Spasticity due to MS of at least one-month duration and not relieved with current therapy, at a level of 4 or more on the numerical rating scale (NRS);
3. Stable dose of standard therapies for at least 30 days prior to the screening visit and willingness for these to be maintained for the duration of the study;
4. Aged 21 years or older;
5. Ability (in the investigator's opinion) and willingness to comply with all study requirements;
6. Ability to speak and read French or English (grade-nine level of language required);

Exclusion Criteria:

Participants will be excluded if any of the following criteria are met:

1. Concomitant disease with symptoms of spasticity, or that may have influenced their level;
2. Received a botulinum toxin injection within four months prior to the screening visit or unwillingness to stop receiving botulinum toxin injections for the duration of the study;
3. Use of cannabis or cannabinoid-based medications within 7 days of study entry and unwillingness to abstain for the duration of the study;
4. History of schizophrenia, other psychotic illness or other significant psychiatric disorder other than anxiety or depression associated with their underlying condition;
5. Alcohol or substance use disorder other than nicotine;
6. History of epilepsy or recurrent seizures;
7. Hypersensitivity to cannabinoids or any of the excipients of the study medication;
8. Clinically relevant cardiac dysfunction within the last 12 months or had a cardiac disorder that, in the opinion of the investigator would put the subject at risk of a clinically relevant arrhythmia or myocardial infarction;
9. Impaired renal function i.e., serum creatinine clearance lower than 50 ml/min;
10. Significantly impaired hepatic function, at visit 1, in the investigator's opinion and/or had liver function tests of equal to or greater than three times the upper limit of normal;
11. Pregnancy or breastfeeding;
12. Men with history of fertility problems and who plan to conceive at any time in the future;
13. Any participant who plans to conceive either at screening or while enrolled in the study;
14. Inability (or unwillingness) of women of childbearing potential and men to use a medically acceptable form of contraception throughout the study duration;
15. Inability to use a medically acceptable form of contraception throughout the study duration; m) any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, may influence the result of the study, or the subject's ability to participate in the study;
16. Intention to travel internationally, or to donate blood during the study.

Where this trial is running

Montreal, Quebec

• Crchum — Montreal, Quebec, Canada (Recruiting)

Study contacts

• Principal investigator: Pierre Duquette, MD — Centre hospitalier de l'Université de Montréal (CHUM)
• Study coordinator: Pierre Duquette

Conditions Multiple Sclerosis