Status:
RECRUITING
The Canadian Maraviroc Randomized Controlled Trial To Augment Rehabilitation Outcomes After Stroke
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
University Health Network, Toronto
University of California, Los Angeles
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
After stroke, the combination of progressive skills practice in an adequate dose plus exercise for fitness augments motor and cognitive outcomes. However, sensorimotor and cognitive improvements often...
Eligibility Criteria
Inclusion
- 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:
- some shoulder abduction with gravity eliminated and visible extension in two or more digits OR
- visible hip flexion or extension
- Subgroup Stratification Criteria
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04789616
Start Date
September 15 2022
End Date
December 1 2025
Last Update
July 9 2024
Active Locations (6)
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1
University of Calgary & Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
2
University of British Columbia & GF Strong Rehabilitation Centre
Vancouver, British Columbia, Canada, V5Z 2G9
3
Dalhousie University
Halifax, Nova Scotia, Canada, B3H 3J5
4
Parkwood Institute
London, Ontario, Canada, N6C 0A7