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New treatment option for Multiple Sclerosis
Official title Cannabis as a Complementary Treatment in Multiple Sclerosis
ClinicalTrials.gov ID: NCT05092191
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- Participants must meet the following criteria:
- Diagnosed with MS (any subtype), for at least six months, by a MS neurologist, according to the recent version of the McDonald criteria;
- 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...
- 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...
- Aged 21 years or older;
You likely can't join if
- Participants will be excluded if any of the following criteria are met:
- Concomitant disease with symptoms of spasticity, or that may have influenced their level;
- Received a botulinum toxin injection within four months prior to the screening visit or unwillingness to stop receiving botulinum toxin injections...
- Use of cannabis or cannabinoid-based medications within 7 days of study entry and unwillingness to abstain for the duration of the study;
- History of schizophrenia, other psychotic illness or other significant psychiatric disorder other than anxiety or depression associated with their...
- Alcohol or substance use disorder other than nicotine;
See the full eligibility criteria
- Participants must meet the following criteria:
- Diagnosed with MS (any subtype), for at least six months, by a MS neurologist, according to the recent version of the McDonald criteria;
- 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);
- 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;
- Aged 21 years or older;
- Ability (in the investigator's opinion) and willingness to comply with all study requirements;
- Ability to speak and read French or English (grade-nine level of language required);
- Participants will be excluded if any of the following criteria are met:
- Concomitant disease with symptoms of spasticity, or that may have influenced their level;
- 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;
- Use of cannabis or cannabinoid-based medications within 7 days of study entry and unwillingness to abstain for the duration of the study;
- History of schizophrenia, other psychotic illness or other significant psychiatric disorder other than anxiety or depression associated with their underlying condition;
- Alcohol or substance use disorder other than nicotine;
- History of epilepsy or recurrent seizures;
- Hypersensitivity to cannabinoids or any of the excipients of the study medication;
- 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...
- Impaired renal function i.e., serum creatinine clearance lower than 50 ml/min;
- 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;
- Pregnancy or breastfeeding;
- Men with history of fertility problems and who plan to conceive at any time in the future;
- Any participant who plans to conceive either at screening or while enrolled in the study;
- Inability (or unwillingness) of women of childbearing potential and men to use a medically acceptable form of contraception throughout the study duration;
- 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...
- Intention to travel internationally, or to donate blood during the study.
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.