Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04789616

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

Led by University of Calgary · Updated on 2024-07-09

120

Participants Needed

6

Research Sites

167 weeks

Total Duration

On this page

Sponsors

U

University of Calgary

Lead Sponsor

U

University Health Network, Toronto

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Primary ischemic anterior circulation stroke
  • Age 18 years or older
  • Stroke occurred at least 5 days ago but within 8 weeks before starting medication
  • Hemiparesis requiring inpatient rehabilitation
  • Assistance available for daily rehabilitation practice and transportation
  • Adequate language skills to understand consent and therapy information
  • At least some shoulder movement with gravity eliminated and finger extension in two or more digits, or visible hip flexion or extension
  • Upper Extremity subgroup: Medical Research Council grade >1 for shoulder abduction and finger extensor on at least two digits, and Upper Extremity Fugl-Meyer Assessment Score ≤56
  • Lower Extremity subgroup: requiring 2-person assist and walking speed less than 0.8 m/s
Not Eligible

You will not qualify if you...

  • Modified Rankin score of 2 or more before stroke
  • Illness or lack of resources preventing return to living outside a facility
  • History of dementia
  • History of hepatitis or elevated liver enzymes
  • History of kidney insufficiency or creatinine clearance under 60 mL/min/1.73m2
  • Cancer or chronic illness limiting 1-year survival or ability to exercise
  • Serious disabling pre-stroke disease such as Parkinson's, severe brain injury, or amputation
  • Seizure related to stroke or epilepsy
  • Current use of carbamazepine, phenobarbital, or phenytoin
  • Pregnancy or breastfeeding, or positive pregnancy test at baseline
  • Women of childbearing potential not using highly effective contraception
  • Known HIV positive status
  • Current use of specific antifungal or antibacterial medications (ketoconazole, itraconazole, voriconazole, rifampin, clarithromycin, rifabutin with protease inhibitor)
  • Current use of St. John's Wort
  • Current use of Paxlovid

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

University of Calgary & Foothills Medical Centre

Calgary, Alberta, Canada, T2N 2T9

Actively Recruiting

2

University of British Columbia & GF Strong Rehabilitation Centre

Vancouver, British Columbia, Canada, V5Z 2G9

Actively Recruiting

3

Dalhousie University

Halifax, Nova Scotia, Canada, B3H 3J5

Actively Recruiting

4

Parkwood Institute

London, Ontario, Canada, N6C 0A7

Actively Recruiting

5

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

Not Yet Recruiting

6

Toronto Rehabilitation Institute - University Health Network

Toronto, Ontario, Canada, M5G 2A2

Not Yet Recruiting

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Research Team

A

Alexandra McKinnon

CONTACT

M

Mark Piitz

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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