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

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.

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).

Sponsors & Collaborators

• University Health Network, Toronto

  collaborator OTHER

• University of California, Los Angeles

  collaborator OTHER

• Sunnybrook Health Sciences Centre

  collaborator OTHER

• University of British Columbia

  collaborator OTHER

• Memorial University of Newfoundland

  collaborator OTHER

• Dalhousie University

  collaborator OTHER

• Parkwood Hospital, London, Ontario

  collaborator OTHER

• Riverview Health Centre Foundation

  collaborator OTHER

• The Dr. Miriam and Sheldon G. Adelson Medical Research Foundation

  collaborator UNKNOWN

• University of Calgary

  lead OTHER

Principal Investigators

• Sean Dukelow, MD PhD FRCPC · University of Calgary, Calgary, Alberta, Canada

• Bruce Dobkin, MD · University of California, Los Angeles, California, USA

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-15

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• Canada

Study Locations