Cannabis as a Complementary Treatment in Multiple Sclerosis

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 currenttherapy, 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 visitand 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 studyrequirements;

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 theirlevel;

2. Received a botulinum toxin injection within four months prior to the screening visitor unwillingness to stop receiving botulinum toxin injections for the duration ofthe study;

3. Use of cannabis or cannabinoid-based medications within 7 days of study entry andunwillingness to abstain for the duration of the study;

4. History of schizophrenia, other psychotic illness or other significant psychiatricdisorder other than anxiety or depression associated with their underlyingcondition;

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 cardiacdisorder that, in the opinion of the investigator would put the subject at risk of aclinically 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 opinionand/or had liver function tests of equal to or greater than three times the upperlimit of normal;

11. Pregnancy or breastfeeding;

12. Men with history of fertility problems and who plan to conceive at any time in thefuture;

13. Any participant who plans to conceive either at screening or while enrolled in thestudy;

14. Inability (or unwillingness) of women of childbearing potential and men to use amedically acceptable form of contraception throughout the study duration;

15. Inability to use a medically acceptable form of contraception throughout the studyduration; m) any other significant disease or disorder which, in the opinion of theinvestigator, may either put the subject at risk because of participation in thestudy, may influence the result of the study, or the subject's ability toparticipate in the study;

16. Intention to travel internationally, or to donate blood during the study.