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RECRUITING

NCT04789616

PHASE2

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

Sponsor: University of Calgary

View on ClinicalTrials.gov

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.

Official title: The CAMAROS Trial: The Canadian Maraviroc Randomized Controlled Trial To Augment Rehabilitation Outcomes After Stroke

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2022-09-15

Completion Date

2025-12

Last Updated

2024-07-09

Healthy Volunteers

Conditions

Stroke

Interventions

DRUG

Maraviroc

Half of the participants will take maraviroc for a period of 8 weeks.

BEHAVIORAL

Exercise Program

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.

OTHER

Placebo

Half of the participants will take a placebo for a period of 8 weeks.

DEVICE

Activity Sensor

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.

BEHAVIORAL

Motor Learning

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).

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

Locations (6)

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