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Studies

Interventional Recruiting Phase 2

NCT05092191 on ClinicalTrials.gov

Cannabis as a Complementary Treatment in Multiple Sclerosis

Official title: Efficacy of Cannabinoids to the Current Standard Treatments on Symptom Relief in Persons With Multiple Sclerosis: Randomized Controlled Trial

  • Sponsor: Centre Hospitalier de l’Université de Montréal
  • Collaborators: Canadian Institutes of Health Research (CIHR), Multiple Sclerosis Society of Canada
  • Enrollment: 250 (Estimated)
  • Study start: 2022-11-10 (Actual)
  • Primary completion: 2025-04-10 (Estimated)
  • Study completion: 2025-05-10 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Factorial
  • Masking: Single (Participant)
  • PrimaryPurpose: Treatment

Brief Summary

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.

Conditions

  • Multiple Sclerosis

Intervention / Treatment

  • Drug: Cannabis oil vs placebo
  • Drug: Cannabis oil vs placebo

Primary Outcome Measures

  • Spasticity patient reported change assessment (Change from Baseline Patient reported spasticity at 28 weeks and 16 weeks)
    Patient-reported spasticity: a Numerical rating scale - 0 (No pain) to 10 (worst pain)

Countries

Canada

Locations and Investigators

  • CRCHUM, Montreal, Canada (Recruiting)
    • Amel, Zertal (Project Manager)
    • Dr Pierre, Duquette (PI)

Study Officials