The Canadian Maraviroc Randomized Controlled Trial To Augment Rehabilitation Outcomes After Stroke
StrokeThe 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.
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Participation Requirements
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Sex:
ALL -
Eligible Ages:
18 and up
Participation 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
Study Location
University of British Columbia & GF Strong Rehabilitation Centre
University of British Columbia & GF Strong Rehabilitation CentreVancouver, British Columbia
Canada
Contact Study Team
Toronto Rehabilitation Institute - University Health Network
Toronto Rehabilitation Institute - University Health NetworkToronto, Ontario
Canada
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University of Calgary & Foothills Medical Centre
University of Calgary & Foothills Medical CentreCalgary, Alberta
Canada
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Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences CentreToronto, Ontario
Canada
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Dalhousie University
Dalhousie UniversityHalifax, Nova Scotia
Canada
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Parkwood Institute
Parkwood InstituteLondon, Ontario
Canada
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- Study Sponsored By
- University of Calgary
- Participants Required
- More Information
- Study ID:
NCT04789616