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RecruitingPHASE2INTERVENTIONAL

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

The CAMAROS trial is a study looking into new ways to help people recover after a stroke. It's testing if a specific drug, Maraviroc (also known as Celsentri), when given alongside an exercise programme, can improve movement in the arms and legs. We know that exercise helps, but recovery often slows down after about three months. Researchers want to see if Maraviroc can extend and improve this recovery period by helping the brain to learn new movements. The study involves people who have had a stroke and will compare those who receive Maraviroc and exercise with those who receive a dummy pill (placebo) and exercise. Participants will be monitored using physical and thinking tests, plus activity sensors.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
University of Calgary
Enrolment target
120
Start
15 Sep 2022
Estimated completion
01 Dec 2025

What is this study about?

When someone has a stroke, it can affect how well they move their arms and legs. Regular exercise and practice are known to help with recovery and can improve both movement and thinking skills. However, this improvement often seems to slow down or even stop after about 12 weeks. This means there's a real need to find new ways to help people continue getting better and regain more movement.

This study is investigating a new approach using a medicine called Maraviroc, which is already approved for other uses. Recent research, both in the lab and observations in stroke patients, suggests that Maraviroc might help the brain learn new things, particularly when combined with rehabilitation exercise. The idea is that it could help extend the period of recovery, especially during the first three months after a stroke, by working on specific ways the brain learns and repairs itself.

The CAMAROS trial aims to see if combining Maraviroc with an exercise programme can really make a difference. It's a 'Phase 2' study, which means it's one of the earlier stages of drug testing, focusing on whether the treatment is effective and safe. The goal is to improve how well people use their arms and legs after a stroke, hoping to give them a fuller and longer-lasting recovery.

Key takeaways

  • This study is testing if a drug + exercise improves stroke recovery.
  • It focuses on regaining movement in arms and legs after a stroke.
  • Participants will follow an 8-week exercise programme.
  • You'll be monitored closely with physical tests and sensors.
  • The study takes place relatively soon after your stroke (within 8 weeks).
  • It's a blinded study, so you won't know if you're taking the active drug or a placebo.

Who may be eligible?

To be part of this study, you would generally need to have had a specific type of stroke (called an ischemic stroke) that affected the front part of your brain. You must be at least 18 years old and have had your stroke no less than 5 days ago, but no more than 8 weeks ago, when you start the medication.

You would also need to have some weakness on one side of your body (hemiparesis) that means you need rehabilitation in hospital. It's important that you have someone who can help you with your daily exercises and with getting to appointments if needed. You also need to understand the study information and be able to follow instructions during therapy sessions. There are also specific checks on how much movement you have in your shoulder, fingers, hip, or leg.

You wouldn't be able to join if you had difficulties before your stroke that meant you needed a lot of help, or if you have certain health conditions like dementia, serious liver or kidney problems, or cancer that could affect your ability to take part or your survival. The study also cannot include pregnant or breastfeeding women, or those taking certain seizure medications.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Did you have a stroke that caused weakness on one side of your body?
  2. Is it between 5 days and 8 weeks since your stroke?
  3. Are you 18 years old or older?
  4. Do you have someone who can help you with daily exercises if needed?
  5. Do you have good enough vision or hearing to understand instructions?
  6. Are you free from serious ongoing health problems like severe kidney disease, liver disease, or cancer?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would begin within 8 weeks of your stroke. You would be assigned to one of two groups: one group receives the active drug Maraviroc, and the other receives a dummy pill (placebo). Neither you nor your doctors would know which you are receiving, as this is a 'blinded' study.

Both groups will take part in an 8-week daily exercise programme, on top of any standard recovery care you're already getting. You'll have several assessments scheduled: at the beginning of the study, after 4 weeks of treatment, after 8 weeks of treatment, and then again 6 months after your stroke. These assessments will involve checks of your physical abilities, your thinking skills, and you'll wear special sensors on your wrist and ankle to monitor your activity. You'll also do short tests to see how quickly you learn new movements, both during your formal appointments and again within 72 hours afterwards, to see how well you remember what you've learned. The total duration of active participation receiving medication and daily exercise is 8 weeks, with follow-up appointments extending to 6 months.

Potential risks and benefits

Taking part in this study could potentially offer benefits, as you would receive an intensive 8-week exercise program along with close monitoring, and you might receive a drug that could improve your stroke recovery. However, there's no guarantee of benefit, as this is a research study. As with all medications, Maraviroc has potential side effects, and some people may experience these. The study doctors and nurses will monitor your health closely throughout. You are free to withdraw from the study at any time, for any reason, without it affecting your ongoing medical care.

Locations (6)

  • University of Calgary & Foothills Medical Centre
    Verified postcode
    Calgary, Canada· Recruiting
  • University of British Columbia & GF Strong Rehabilitation Centre
    Verified postcode
    Vancouver, Canada· Recruiting
  • Dalhousie University
    Verified postcode
    Halifax, Canada· Recruiting
  • Parkwood Institute
    Verified postcode
    London, Canada· Recruiting
  • Sunnybrook Health Sciences Centre
    Verified postcode
    Toronto, Canada· Not yet recruiting
  • Toronto Rehabilitation Institute - University Health Network
    Verified postcode
    Toronto, Canada· Not yet recruiting

Common questions

What is the main goal of this study?

The study aims to see if combining a drug called Maraviroc with exercise can improve arm and leg movement after a stroke.

What is Maraviroc?

Maraviroc is a drug that is already used for other medical conditions. This study is exploring if it can also help the brain recover after a stroke.

Will I know if I'm getting the drug or a dummy pill?

No, neither you nor your doctors will know if you're getting Maraviroc or a placebo (dummy pill). This is a standard way to ensure the study results are fair.

How long will I be involved in the study?

You will take part in an 8-week active treatment and exercise program, with follow-up assessments lasting up to 6 months from your stroke.

What if I change my mind about participating?

You have the right to withdraw from the study at any time, for any reason, and it will not affect your medical care.

How to find out more

Alexandra McKinnon

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "The Canadian Maraviroc Randomized Controlled Trial To Augmen…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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