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

Stroke

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.

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Conditions de participation

  • Sexe:

    ALL
  • Âges admissibles:

    18 and up

Critères de participation

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

Lieu de l'étude

University of British Columbia & GF Strong Rehabilitation Centre
University of British Columbia & GF Strong Rehabilitation Centre
Vancouver, British Columbia
Canada

Contactez l'équipe d'étude

Primary Contact

Courtney Pollock

[email protected]
604-827-1631
Toronto Rehabilitation Institute - University Health Network
Toronto Rehabilitation Institute - University Health Network
Toronto, Ontario
Canada

Contactez l'équipe d'étude

Primary Contact

Olga Yaroslavtseva

[email protected]
416-597-3422
University of Calgary & Foothills Medical Centre
University of Calgary & Foothills Medical Centre
Calgary, Alberta
Canada

Contactez l'équipe d'étude

Primary Contact

Alexandra McKinnon

[email protected]
403-944-4050
Backup Contact

Mark Piitz

[email protected]
403-944-4050
Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
Toronto, Ontario
Canada

Contactez l'équipe d'étude

Primary Contact

Olga Yaroslavtseva

[email protected]
Dalhousie University
Dalhousie University
Halifax, Nova Scotia
Canada

Contactez l'équipe d'étude

Primary Contact

Melanie Dunlop

[email protected]
902-473-1401
Parkwood Institute
Parkwood Institute
London, Ontario
Canada

Contactez l'équipe d'étude

Primary Contact

Shiela Geniblazo

[email protected]
Étude parrainée par
University of Calgary
Participants recherchés
Plus d'informations
ID de l'étude: NCT04789616