The Canadian Maraviroc Randomized Controlled Trial To Augment Rehabilitation Outcomes After Stroke

What this study is about

The CAMAROS trial is a randomized controlled phase II trial analyzing the effect of coupling a C-C chemokine receptor 5 (CCR5) antagonist, Maraviroc (Celsentri), and exercise to improve both upper and lower extremity recovery after a stroke.

Who can join (things the study team will check)

✅ You may be able to join if…

• Primary ischemic anterior circulation stroke
• Age ≥18 years
• At least 5 days after stroke but within 8 weeks of stroke on the date of medication (maraviroc or placebo) start
• Hemiparesis requiring inpatient rehabilitation
• Assistance available for daily rehabilitation training practice and for transportation when needed
• Adequate language skills to understand the Informed Consent and retain information during daily therapies
• At least one of the following: Subgroup Stratification Criteria
  • some shoulder abduction with gravity eliminated and visible extension in two or more digits OR
  • visible hip flexion or extension
• For Upper Extremity Group:
  • Minimum Ability: Medical Research Council (MRC) grade >1 for shoulder abduction AND MRC grade >1 for finger extensor on at least two digits
  • Maximum Ability: Upper Extremity Fugl-Meyer Assessment Score >56
• For Lower Extremity Group:
  • Minimum Ability: requiring a 2-person assist
  • Maximum Ability: walking speed <0.8m/s

🚫 You may not be able to join if…

• Pre-stroke modified Rankin score ≥ 2
• Limited resources or illness that will not enable a return to living outside of a facility
• History of dementia
• History of hepatitis or elevated hepatic transaminases or bilirubin
• History of renal insufficiency or creatinine clearance (eGFR) < 60mL / min / 1.73m2
• Cancer or other chronic illness that makes 1-year survival unlikely or will detract from the ability to carry out exercise and skills practice
• Existing pre-stroke serious disabling disease (e.g., Parkinson's disease, severe traumatic brain injury, amputation)
• Seizure related to stroke
• Acute or chronic epilepsy
• Currently taking any of the following anticonvulsant medications:
  • Carbamazepine
  • Phenobarbital
  • Phenytoin
• Pregnant, breastfeeding, or positive test for pregnancy at baseline
• Women of childbearing potential who are not using one highly effective form of contraception or two forms of effective contraception
• Known HIV positivity
• Currently taking any of the following antifungal and/or antibacterial medications:
  • Ketoconazole
  • Itraconazole
  • Voriconazole
  • Rifampin
  • Clarithromycin
  • Rifabutin + Protease Inhibitor
• Currently taking St. John's Wort
• Currently taking Paxlovid

Where this trial is running

• University of Calgary & Foothills Medical Centre, Calgary, Alberta, Canada
• University of British Columbia & GF Strong Rehabilitation Centre, Vancouver, British Columbia, Canada
• Dalhousie University, Halifax, Nova Scotia, Canada
• Parkwood Institute, London, Ontario, Canada
• Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
• Toronto Rehabilitation Institute - University Health Network, Toronto, Ontario, Canada

Who to contact

Alexandra McKinnon · 403-944-4050 · alexandra.mckinnon@ucalgary.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT04789616.