NCT04789616 The Canadian Maraviroc Randomized Controlled Trial To Augment Rehabilitation Outcomes After Stroke
| NCT ID | NCT04789616 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Calgary |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-09-15 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2022-09-15 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Sean Dukelow, MD PhD FRCPC
PRINCIPAL INVESTIGATOR
University of Calgary
Frequently Asked Questions
Who can join the NCT04789616 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04789616 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04789616 currently recruiting?
Yes, NCT04789616 is actively recruiting participants. Contact the research team at alexandra.mckinnon@ucalgary.ca for enrollment information.
Where is the NCT04789616 trial being conducted?
This trial is being conducted at Calgary, Canada, Vancouver, Canada, Halifax, Canada, London, Canada and 2 additional locations.
Who is sponsoring the NCT04789616 clinical trial?
NCT04789616 is sponsored by University of Calgary. The principal investigator is Sean Dukelow, MD PhD FRCPC at University of Calgary. The trial plans to enroll 120 participants.
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