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New treatment option for Stroke
Official title The Canadian Maraviroc Randomized Controlled Trial To Augment Rehabilitation Outcomes After Stroke
ClinicalTrials.gov ID: NCT04789616
What this study is testing
What is Maraviroc?
Maraviroc is an investigational medicine, given as an once-daily, being studied as a potential treatment for stroke.
Also referred to as Celsentri.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Primary ischemic anterior circulation stroke
- Age ≥18 years
- At least 5 days after stroke but within 8 weeks of stroke on the date of medication (maraviroc or placebo) start
- Hemiparesis requiring inpatient rehabilitation
- Assistance available for daily rehabilitation training practice and for transportation when needed
You likely can't join if
- Pre-stroke modified Rankin score ≥ 2
- Limited resources or illness that will not enable a return to living outside of a facility
- History of dementia
- History of hepatitis or elevated hepatic transaminases or bilirubin
- History of renal insufficiency or creatinine clearance (eGFR) \< 60mL / min / 1.73m2
- Cancer or other chronic illness that makes 1-year survival unlikely or will detract from the ability to carry out exercise and skills practice
See the full eligibility criteria
- Primary ischemic anterior circulation stroke
- Age ≥18 years
- At least 5 days after stroke but within 8 weeks of stroke on the date of medication (maraviroc or placebo) start
- Hemiparesis requiring inpatient rehabilitation
- Assistance available for daily rehabilitation training practice and for transportation when needed
- Adequate language skills to understand the Informed Consent and retain information during daily therapies
- 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
- 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
- For Lower Extremity Group:
- Minimum Ability: requiring a 2-person assist
- Maximum Ability: walking speed \<0.8m/s
- Pre-stroke modified Rankin score ≥ 2
- Limited resources or illness that will not enable a return to living outside of a facility
- History of dementia
- History of hepatitis or elevated hepatic transaminases or bilirubin
- History of renal insufficiency or creatinine clearance (eGFR) \< 60mL / min / 1.73m2
- Cancer or other chronic illness that makes 1-year survival unlikely or will detract from the ability to carry out exercise and skills practice
- Existing pre-stroke serious disabling disease (e.g., Parkinson's disease, severe traumatic brain injury, amputation)
- Seizure related to stroke
- Acute or chronic epilepsy
- Currently taking any of the following anticonvulsant medications:
- Carbamazepine
- Phenobarbital
- Phenytoin
- Pregnant, breastfeeding, or positive test for pregnancy at baseline
- Women of childbearing potential who are not using one highly effective form of contraception or two forms of effective contraception
- Known HIV positivity
- Currently taking any of the following antifungal and/or antibacterial medications:
- Ketoconazole
- Itraconazole
- Voriconazole
- Rifampin
- Clarithromycin
- Rifabutin + Protease Inhibitor
- Currently taking St. John's Wort
- Currently taking Paxlovid
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- Vancouver, British Columbia, Canada
- Halifax, Nova Scotia, Canada
- London, Ontario, Canada
- Toronto, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada; Vancouver, British Columbia, Canada; Halifax, Nova Scotia, Canada; London, Ontario, Canada; Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.