The Canadian Maraviroc RCT To Augment Rehabilitation Outcomes After Stroke

• Status: Not yet recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Calgary
• Collaborators: Dalhousie University; Memorial University of Newfoundland; Parkwood Hospital, London, Ontario; Riverview Health Centre Foundation; Sunnybrook Health Sciences Centre; The Dr. Miriam and Sheldon G. Adelson Medical Research Foundation; University Health Network, Toronto; University of British Columbia; University of California, Los Angeles
• Treatments: Maraviroc

Criteria

Inclusion Criteria:

1. Primary ischemic anterior circulation stroke

2. Age ≥18 years

3. At least 5 days after stroke but within 6 weeks of stroke

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: MRC grade >1 for shoulder abduction AND MRC grade >1 for finger extensor on at least one digit

• 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, no visible hip flexion or extension

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. Cancer or other chronic illness that makes 3-year survival unlikely or will detract from the ability to carry out exercise and skills practice

4. Existing pre-stroke serious disabling disease (e.g., Parkinson's disease, severe traumatic brain injury, amputation)

5. Seizure related to stroke

6. Acute or chronic epilepsy

7. History of:

• dementia

• hepatitis or elevated hepatic transaminases or bilirubin

• renal insufficiency or serum creatinine over 1.6