CLINICAL TRIAL

Maraviroc for Stroke

Waitlist Available · 18+ · All Sexes · Toronto, Canada

This study is evaluating whether a drug that blocks a receptor for a chemokine that is important for immune system function can improve recovery after a stroke.

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About the trial for Stroke

Treatment Groups

This trial involves 2 different treatments. Maraviroc is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Exercise Program
BEHAVIORAL
Activity Sensor
DEVICE
Motor Learning
BEHAVIORAL
Maraviroc
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Exercise Program
BEHAVIORAL
Activity Sensor
DEVICE
Motor Learning
BEHAVIORAL
Placebo
OTHER

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise Program
2016
Completed Phase 3
~4940
Motor Learning
2001
N/A
~40
Maraviroc
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
You have had a stroke within the last 6 weeks. show original
Primary ischemic anterior circulation stroke
Age ≥18 years
Hemiparesis requiring inpatient rehabilitation
Assistance available for daily rehabilitation training practice and for transportation when needed
You have shoulder abduction with gravity eliminated and visible extension in two or more digits OR visible hip flexion or extension. show original
Subgroup Stratification Criteria
Minimum Ability: MRC grade >1 for shoulder abduction AND MRC grade >1 for finger extensor on at least one digit
You have a maximum score of 56 on the Upper Extremity Fugl-Meyer Assessment. show original
You have adequate language skills to understand the Informed Consent and retain information during daily therapies. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline (between 5 days and 6 weeks after stroke), after 8 weeks on drug/placebo, and 6-months post-stroke
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline (between 5 days and 6 weeks after stroke), after 8 weeks on drug/placebo, and 6-months post-stroke
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline (between 5 days and 6 weeks after stroke), after 8 weeks on drug/placebo, and 6-months post-stroke.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Maraviroc will improve 2 primary outcomes, 2 secondary outcomes, and 7 other outcomes in patients with Stroke. Measurement will happen over the course of Baseline (between 5 days and 6 weeks after stroke), after 8 weeks on drug/placebo, and 6-months post-stroke.

Patient Health Questionnaire 9 (PHQ-9)
BASELINE (BETWEEN 5 DAYS AND 6 WEEKS AFTER STROKE), AFTER 8 WEEKS ON DRUG/PLACEBO, AND 6-MONTHS POST-STROKE
A 9-question measurement used to screen for the presence and severity of depression.
BASELINE (BETWEEN 5 DAYS AND 6 WEEKS AFTER STROKE), AFTER 8 WEEKS ON DRUG/PLACEBO, AND 6-MONTHS POST-STROKE
Action Research Arm Test (ARAT)
BASELINE (BETWEEN 5 DAYS AND 6 WEEKS AFTER STROKE), AFTER 4 WEEKS ON DRUG/PLACEBO, AFTER 8 WEEKS ON DRUG/PLACEBO, AND 6-MONTHS POST-STROKE
The ARAT assesses arm function to determine the quality of the arm movement, and the limitation of activity. The ARAT consists of 4 sub-tests; that examines and individual's grip, grasp, pinch and gross motor movement in order to determine upper extremity function. Objects of varying size, shape, and weight must be either grasped, handled or moved in a specific task in order to evaluate function. Low scores mean worse function with the minimum possible score being 0 and the highest possible score being 57 (normal function).
BASELINE (BETWEEN 5 DAYS AND 6 WEEKS AFTER STROKE), AFTER 4 WEEKS ON DRUG/PLACEBO, AFTER 8 WEEKS ON DRUG/PLACEBO, AND 6-MONTHS POST-STROKE
Change in Fugl-Meyer Upper Extremity Assessment Score
BASELINE (BETWEEN 5 DAYS AND 6 WEEKS AFTER STROKE), AFTER 4 WEEKS ON DRUG/PLACEBO, AFTER 8 WEEKS ON DRUG/PLACEBO, AND 6-MONTHS POST-STROKE
Difference in subscale scores on the Upper-Extremity Fugl-Meyer Assessment - both motor (max 66) and sensory (max 12) components. Higher scores indicate better outcome.
BASELINE (BETWEEN 5 DAYS AND 6 WEEKS AFTER STROKE), AFTER 4 WEEKS ON DRUG/PLACEBO, AFTER 8 WEEKS ON DRUG/PLACEBO, AND 6-MONTHS POST-STROKE
Change in 10-Meter Walk Test Score
BASELINE (BETWEEN 5 DAYS AND 6 WEEKS AFTER STROKE), AFTER 4 WEEKS ON DRUG/PLACEBO, AFTER 8 WEEKS ON DRUG/PLACEBO, AND 6-MONTHS POST-STROKE
A performance measure used to assess walking speed in meters per second over a short distance. It can be used to determine functional mobility, gait, and vestibular function. Faster speed indicates better function.
BASELINE (BETWEEN 5 DAYS AND 6 WEEKS AFTER STROKE), AFTER 4 WEEKS ON DRUG/PLACEBO, AFTER 8 WEEKS ON DRUG/PLACEBO, AND 6-MONTHS POST-STROKE
Stroke Aphasia Depression Questionnaire (SADQ)
BASELINEBASELINE (BETWEEN 5 DAYS AND 6 WEEKS AFTER STROKE), AFTER 8 WEEKS ON DRUG/PLACEBO, AND 6-MONTHS POST-STROKE, 8-WEEK ASSESSMENT, AND 6-MONTH ASSESSMENT
A 10-item questionnaire completed by a caregiver to quickly assess depressive symptoms in stroke patients with aphasia. Higher scores indicate a greater likelihood of depression.
BASELINEBASELINE (BETWEEN 5 DAYS AND 6 WEEKS AFTER STROKE), AFTER 8 WEEKS ON DRUG/PLACEBO, AND 6-MONTHS POST-STROKE, 8-WEEK ASSESSMENT, AND 6-MONTH ASSESSMENT
Montreal Cognitive Assessment (MoCA)
BASELINE (BETWEEN 5 DAYS AND 6 WEEKS AFTER STROKE) AND 6-MONTHS POST-STROKE
A cognitive screening test used to assess: short term memory, visuospatial abilities, executive functions, attention, concentration, working memory, language, and orientation to time and place. Higher scores indicate better function.
BASELINE (BETWEEN 5 DAYS AND 6 WEEKS AFTER STROKE) AND 6-MONTHS POST-STROKE
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get stroke a year in the United States?

Given the large number of stroke cases in the US, future research will need to identify which demographic characteristics and lifestyles contribute to stroke risk.

Anonymous Patient Answer

What are the signs of stroke?

Symptoms can be broken into 3 main groups; acute, sub-acute and chronic. The acute stroke syndrome is associated with unilateral symptoms; however, the sub-acute and chronic stroke syndromes are associated with bilateral symptoms.

Anonymous Patient Answer

What is stroke?

Stroke is a medical emergency that requires immediate, effective treatment. Stroke causes major losses of life, disability, and economic costs. Every second stroke results in disability, and every second stroke (and stroke survivor) may die.

Anonymous Patient Answer

What causes stroke?

A number of possible causes of stroke have been reviewed. Theories of the causes of stroke have implications for the development of stroke prevention and treatment. These include the traditional risk factors and non-traditional risk factors.

Anonymous Patient Answer

Can stroke be cured?

Given that the disease is a process not a static condition, that its effects vary over time and are dependent on the specific individual's circumstances and response, that its course may be very different from that of other diseases, and that more effective methods have been recommended, it seems that the possibility of a cure is extremely remote.

Anonymous Patient Answer

What are common treatments for stroke?

Common treatments for stroke include antiplatelet agents such as aspirin and clopidogrel, and statin for prevention of cardiovascular disease. Beta-blockers and carotid endarterectomy may be helpful for preventing recurrent stroke. Exercise and physical therapy are often recommended for stroke. There is no known cure for stroke.\n

Anonymous Patient Answer

Does stroke run in families?

There were no associations between genetic markers and stroke risk. No evidence has shown that stroke is influenced by a genetic profile and familial relationships. Nevertheless, the results point to the need to study genetic influences in populations at risk even if the gene(s) responsible have not yet been identified.

Anonymous Patient Answer

What is the primary cause of stroke?

The main cause of stroke in this study was atherosclerosis. The primary risk factor for atherosclerosis is age. It has been demonstrated that people of every age suffer from stroke but people who are younger than 40 have disproportionately high rates of stroke, even after adjustment for atherosclerosis and other risk factors. People who are older than 40 have the second highest rates of stroke after those who have high cholesterol levels. People with hypertension may have a greater risk of a hemorrhagic stroke than individuals without hypertension. Blood pressure control is a top priority in prevention of strokes in both young and aging populations. The relative risks of stroke vary according to the age groups in which it occurs.

Anonymous Patient Answer

Have there been any new discoveries for treating stroke?

Most recent advances in the treatment of stroke have been made by the medical communities from research in the treatment of other conditions. These advances are not new discoveries in stroke research, but rather applying existing, known treatments more correctly and efficiently in this particular disease. The advances are discussed together with the limitations of these interventions with respect to the treatment of stroke.

Anonymous Patient Answer

What does maraviroc usually treat?

It appears that maraviroc has been used in HIV/HCV-coinfected patients to treat HCMV infections. The first case report of maraviroc being used for this indication was published in 2000. The FDA approved maraviroc for use as a HCV treatment in 2004. As a result of this, it is also likely to be the most-widely used candidate for HCMV treatment until much more evidence becomes available.

Anonymous Patient Answer

How serious can stroke be?

It is easy to find the pictures on media and in books and movies to show what is the effect of stroke and what is being done to reverse it. For patients, that looks like a miracle. It is hard to tell, without getting there myself, how far can we go. I don’t think that any of us are quite sure what is happening when we suffer stroke. But as far as we know, that is more or less the case with what we are told about the effects of stroke by health and stroke societies.

Anonymous Patient Answer

How does maraviroc work?

Maraviroc is in late stage phase II/III clinical development for the treatment of HIV infection. Thus, the use of this drug would be limited to salvage therapy for patients with HIV infection who have acquired multidrug-resistant HIV and HIV/HIV co-infection following failed use of therapy.

Anonymous Patient Answer
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