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Cannabinoid

Cannabis for Multiple Sclerosis (CANSEP Trial)

Phase 2

Recruiting

Led By Pierre Duquette, MD

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 21 years or older

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)

Must not have

Impaired renal function i.e., serum creatinine clearance lower than 50 ml/min

History of epilepsy or recurrent seizures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline sleep at 28 weeks and 16 weeks

Summary

This trialwill assess the effects of cannabis on MS symptoms, such as spasticity, pain, and fatigue.

Who is the study for?

This trial is for adults over 21 with Multiple Sclerosis (MS) who experience spasticity not relieved by current therapy. Participants must have stable MS treatments for the last 30 days and be able to follow study procedures. They should not have severe psychiatric disorders, substance abuse issues, significant liver or heart problems, or plans to conceive.

What is being tested?

The study tests whether cannabis oil containing different doses of THC alone, CBD alone, or both combined can help relieve spasticity in MS compared to a placebo. The effectiveness of these cannabinoids on symptoms like pain and cognitive abilities will also be evaluated.

What are the potential side effects?

Potential side effects may include dizziness, dry mouth, changes in appetite or mood swings due to THC; CBD might cause fatigue or diarrhea. Side effects vary from person to person based on individual reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 21 years old or older.

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My MS-related muscle stiffness has been severe for over a month and current treatments aren't helping.

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I have been diagnosed with MS for at least six months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is reduced with a creatinine clearance below 50 ml/min.

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I have a history of epilepsy or seizures.

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I have not had schizophrenia or other major psychiatric disorders, except for anxiety or depression due to my condition.

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I have not had a botulinum toxin injection in the last 4 months and am willing to avoid them during the study.

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I cannot or will not use birth control during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline pain at 28 weeks and 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline pain at 28 weeks and 16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline pain at 28 weeks and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Spasticity patient reported change assessment

Other study objectives

Anxiety/Depression change assessement

Bowel /Bladder dysfunction change assessement

Cannabis use disorder assesssment

+11 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: THC and CBD combinedExperimental Treatment1 Intervention

* 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.

Group II: THC aloneExperimental Treatment1 Intervention

* 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.

Group III: CBD aloneExperimental Treatment1 Intervention

* 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.

Group IV: PlaceboPlacebo Group1 Intervention

* Dosage form : Softgel * Dosage \& frequency : caps of placebo twice a day * Duration : 4 weeks of treatment followed by 12 additional weeks of follow up.

0 / 8Eligibility criteria met