The Canadian Maraviroc Randomized Controlled Trial To Augment Rehabilitation Outcomes After Stroke
The CAMAROS Trial: The Canadian Maraviroc Randomized Controlled Trial To Augment Rehabilitation Outcomes After Stroke
University of Calgary
120 participants
Sep 15, 2022
INTERVENTIONAL
Conditions
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 lower extremity recovery after a stroke.
Eligibility
Inclusion Criteria16
- 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 Criteria25
- 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
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Interventions
Half of the participants will take maraviroc for a period of 8 weeks.
All participants will take part in an 8-week exercise program. While in-hospital, participants will undergo standard of care rehabilitation (estimated at 45 minutes each daily for physiotherapy \& occupational therapy) plus a supplementary upper extremity exercise program (Graded Repetitive Arm Supplementary Program (GRASP); estimated at 1 hour daily). After discharge from inpatient care, participants will complete an at-home supplementary upper and lower extremity exercise program. This program will include 30 minutes daily walking or sit-to-stand exercises and 30 minutes daily practice using the GRASP program.
Half of the participants will take a placebo for a period of 8 weeks.
Participants will be asked to wear small activity sensors (one on each wrist and one on each ankle, total of four sensors) at the baseline, 4-week, 8-week, and 6-month assessments for 7 consecutive days. Activity related to walking, sleep, physical activity, and arm and leg movement throughout the day will be measured. The sensors will be worn for a total of 28 days throughout the study.
Participants will be asked to perform a computer-based motor learning assessment at the baseline, 4-week, 8-week, and 6-month assessments. A retention task, which involves shorter versions of the initial tasks, will also be completed within 72 hours of the initial assessment (initial test and retention test).
Locations(6)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04789616