Multiple Sclerosis Clinical Trial
— CANSEPOfficial title:
Efficacy of Cannabinoids to the Current Standard Treatments on Symptom Relief in Persons With Multiple Sclerosis: Randomized Controlled Trial
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.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | March 15, 2025 |
Est. primary completion date | March 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | CRCHUM | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Centre hospitalier de l'Université de Montréal (CHUM) | Canadian Institutes of Health Research (CIHR), Multiple Sclerosis Society of Canada |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Spasticity change Clinician assessment | Spasticity: Ashworth scale -1 (normal) to 4 (rigid) | Change from Baseline Clinician evaluation spasticity at 28 weeks and 16 weeks | |
Other | Pain change assessment | Pain: Pain Effects-1 (Not at all) to 4 (extreme) | Change from Baseline pain at 28 weeks and 16 weeks | |
Other | Mobility Change assessement | Mobility: Timed 25-Foot Walk test | Change from Baseline mobility at 28 weeks and 16 weeks | |
Other | Fatigue change assessement | Fatigue: Modified Fatigue Impact Scale-0 (never) to 4 (always) | Change from Baseline fatigue at 28 weeks and 16 weeks | |
Other | Sleep change assessement | Sleep: Pittsburgh Study Quality sleep Index-0 (no difficult) to 3 (severe) | Change from Baseline sleep at 28 weeks and 16 weeks | |
Other | Drowsiness change assessement | Drowsiness: Epworth Sleepiness scale-0 (no chance) to 3 (High chance) | Change from Baseline Drowsiness at 28 weeks and 16 weeks | |
Other | Bowel /Bladder dysfunction change assessement | Bowel /Bladder dysfunction: Bowel/Bladder Control Scale-0 (not at all) to 4 (Daily) | Change from Baseline Bowel/Bladder dysfunction at 28 weeks and 16 weeks | |
Other | Sexual dysfunction change assessement | Sexual dysfunction: Sexual Satisfaction Scale-0 (Extremely Satisfied) to 6 (Extremely Dissatisfied) | Change from Baseline Sexual dysfunction at 28 weeks and 16 weeks | |
Other | Restless Legs Syndrome change assessement | Restless Legs Syndrome - 4 (V.severe) to 0 (None) | Change from Baseline Restless Legs Syndrome at 28 weeks and 16 weeks | |
Other | Mental Health disorder change assessement | Mental Health issues: Mental Health inventory-1 (All of the time) to 6 (None of the time) | Change from Baseline Mental Health at 28 weeks and 16 weeks | |
Other | Anxiety/Depression change assessement | Anxiety/Depression: Hospital Anxiety and Depression-0 to 3 (highest level) | Change from Baseline Anxiety/Depression at 28 weeks and 16 weeks | |
Other | Cannabis use disorder assesssment | Cannabis use disorder : diagnosis | Cannabis use disorder : assessment at only baseline | |
Other | Cognition change assessement | Cognition tests | Change from Baseline cognition at 28 weeks and 16 weeks | |
Other | Quality of life change assessement | Quality of life: Health Status Questionnaire (Higher scores indicate better health) | Change from Baseline Quality of life at 28 weeks and 16 weeks | |
Primary | Spasticity patient reported change assessment | Patient-reported spasticity: a Numerical rating scale - 0 (No pain) to 10 (worst pain) | Change from Baseline Patient reported spasticity at 28 weeks and 16 weeks |
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