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

Launched by UNIVERSITY OF CALGARY · Mar 5, 2021

Keywords

ClinConnect Summary

The CAMAROS trial is a research study looking at how a medication called Maraviroc, combined with exercise, can help improve recovery for people who have had a stroke. Specifically, the trial focuses on those who have experienced a type of stroke that affects the front part of the brain, known as an ischemic anterior circulation stroke. Participants must be at least 18 years old, have some movement in their arms or legs, and be within 8 weeks of their stroke. They also need to have support available for daily rehabilitation practices.

If someone joins the trial, they will receive either Maraviroc or a placebo (a pill with no active medication) while also participating in rehabilitation exercises. This study is currently recruiting participants of all genders, and it’s important to note that individuals with certain health conditions, such as severe dementia or ongoing serious illnesses, will not be eligible. Overall, this trial aims to find out if Maraviroc can enhance the benefits of rehabilitation after a stroke, helping patients regain more movement and independence.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Primary ischemic anterior circulation stroke
• • 2. Age ≥18 years
• • 3. At least 5 days after stroke but within 8 weeks of stroke on the date of medication (maraviroc or placebo) start
• • 4. Hemiparesis requiring inpatient rehabilitation
• • 5. Assistance available for daily rehabilitation training practice and for transportation when needed
• • 6. Adequate language skills to understand the Informed Consent and retain information during daily therapies
• 7. At least one of the following:
• • some shoulder abduction with gravity eliminated and visible extension in two or more digits OR
• • visible hip flexion or extension
• • Subgroup Stratification Criteria
• 1. 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
• 2. For Lower Extremity Group:
• • Minimum Ability: requiring a 2-person assist
• • Maximum Ability: walking speed \<0.8m/s
• Exclusion Criteria:
• • 1. Pre-stroke modified Rankin score ≥ 2
• • 2. Limited resources or illness that will not enable a return to living outside of a facility
• • 3. History of dementia
• • 4. History of hepatitis or elevated hepatic transaminases or bilirubin
• • 5. History of renal insufficiency or creatinine clearance (eGFR) \< 60mL / min / 1.73m2
• • 6. Cancer or other chronic illness that makes 1-year survival unlikely or will detract from the ability to carry out exercise and skills practice
• • 7. Existing pre-stroke serious disabling disease (e.g., Parkinson's disease, severe traumatic brain injury, amputation)
• • 8. Seizure related to stroke
• • 9. Acute or chronic epilepsy
• 10. Currently taking any of the following anticonvulsant medications:
• • Carbamazepine
• • Phenobarbital
• • Phenytoin
• • 11. Pregnant, breastfeeding, or positive test for pregnancy at baseline
• • 12. Women of childbearing potential who are not using one highly effective form of contraception or two forms of effective contraception
• • 13. Known HIV positivity
• 14. Currently taking any of the following antifungal and/or antibacterial medications:
• • Ketoconazole
• • Itraconazole
• • Voriconazole
• • Rifampin
• • Clarithromycin
• • Rifabutin + Protease Inhibitor
• • 15. Currently taking St. John's Wort
• • 16. Currently taking Paxlovid