Trial - CAMAROS
Contact information for trial coordinators and research leaders is available here: http://canadianstroke.ca/sites/default/files/inline-files/CanStroke.pdf
The Canadian Maraviroc Randomized Controlled Trial To Augment Rehabilitation Outcomes After Stroke (CAMAROS)
Dr. Sean Dukelow, University of Calgary
Dr. Mark Bayley, Toronto Rehabilitation Institute – University Health Network
Dr. Bruce Dobkin, University of California, Los Angeles
Drs. Bradley MacIntosh and Sandra Black, Sunnybrook Health Sciences Centre
Drs. Janice Eng, Courtney Pollock, and Jennifer Yao, University of British Columbia & GF Strong Rehab Centre
Drs. Michelle Ploughman and Jason McCarthy, Memorial University of Newfoundland
Drs. Marilyn Mackay-Lyons and Anita Mountain, Dalhousie University
Dr. Robert Teasell, Parkwood Institute
Dr. Sepideh Pooyania, Riverview Health Centre
Maraviroc, a CCR5 reversible co-receptor antagonist, has been shown to improve motor outcomes when coupled with training in preclinical models of stroke. Several recent preclinical experiments and observational studies in stroke patients have also shown that maraviroc can facilitate skills learning during rehabilitation, especially if given early after stroke. Given the potential for maraviroc to augment learning, the study rationale is that recovery could be improved by pairing maraviroc and rehabilitation therapy post-stroke.
This clinical trial aims to recruit up to 120 stroke patients across multiple (7-12) sites in Canada. Participants will be recruited within six weeks of stroke onset. Over eight weeks, half of the participants will be given maraviroc (Celsentri) while the other half will be given placebo. While on drug/placebo, participants will receive standard of care post-stroke rehabilitation therapy and a supplementary upper and lower extremity exercise program for a total of eight weeks. Participants will get training while in hospital on how to use the supplementary exercise program at home. Participants will also be asked to wear sensors at various timepoints during the study to measure activity levels. Evaluation assessments will occur at baseline, four- and eight-weeks post-drug/placebo start, and 6-months post-stroke.
Potential participants will be identified by the multidisciplinary team caring for the patient and referred to the study team, and consent will be acquired prior to participating in the study.