Phase 2 Multiple Sclerosis Trial, Recruiting NCT05092191 Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) Condition: Multiple Sclerosis
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Phase 2 Multiple Sclerosis Trial, Recruiting

NCT05092191
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with multiple sclerosis (MS, any type) for at least six months, confirmed by an MS neurologist using recognised diagnostic guidelines
  • People who have had muscle stiffness or spasms (spasticity) caused by MS for at least one month, which has not been adequately relieved by current treatments, and rates at 4 or higher on a pain/symptom scale of 0–10
  • People who have been on a stable dose of their current MS treatments for at least 30 days before the initial screening appointment, and who are willing to keep those treatments unchanged throughout the study
  • People aged 21 years or older
  • People who, in the trial investigator's opinion, are able and willing to follow all study requirements
  • People who can speak and read French or English at approximately a grade-nine level

Who may not be able to join:

  • People who have another condition (besides MS) that causes or affects muscle spasticity
  • People who have received botulinum toxin (e.g. Botox) injections within the four months before screening, or who are unwilling to stop receiving these injections for the duration of the study
  • People who have used cannabis or cannabis-based medicines within seven days of entering the study, or who are unwilling to avoid these for the duration of the study
  • People with a history of schizophrenia, psychosis, or other significant psychiatric conditions (not including anxiety or depression related to their MS)
  • People with a history of alcohol or substance use disorder (not including nicotine use)
  • People with a history of epilepsy or recurring seizures
  • People with a known allergy or sensitivity to cannabinoids or any ingredient in the study medication
  • People who have had a significant heart condition or heart-related problem in the past 12 months, or who have a heart condition that the investigator believes could put them at risk of a serious heart event
  • People whose kidneys are not functioning well enough (as measured by a specific blood test result below a set level) (confirm with trial site)
  • People with significantly reduced liver function or abnormal liver test results that are three times or more above the normal range
  • People who are pregnant or breastfeeding
  • Men with a history of fertility problems who plan to try to conceive at any point in the future
  • People who plan to try to conceive either at the time of screening or while enrolled in the study
  • People who are unwilling or unable to use an acceptable form of contraception throughout the entire study (applies to both women who could become pregnant and men)
  • People who have any other significant illness or condition that the investigator believes could put them at risk, affect the study results, or affect their ability to take part
  • People who plan to travel internationally or donate blood during the study period

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Pierre Duquette, MD, Centre hospitalier de l'Université de Montréal (CHUM)

Phone: 514 890 8000

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Registry
ClinicalTrials.gov
Start date
10 November 2022
Est. completion
10 April 2025

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Spasticity patient reported change assessment

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov