What side effects are associated with this type of intervention?

Common treatments for stroke include thrombolytics, antiplatelet agents, anticoagulants, and neuroprotective agents. Thrombolytics, such as tissue plasminogen activator (tPA), can cause bleeding complications, including intracerebral hemorrhage. Antiplatelet agents like aspirin may lead to gastrointestinal bleeding and ulcers. Anticoagulants, such as warfarin, carry risks of bleeding and require regular monitoring. Neuroprotective agents are still under investigation, and their side effects vary. For treatments similar to Maraviroc (Celsentri), a CCR5 antagonist, side effects may include liver enzyme elevations, rash, and gastrointestinal symptoms. It is essential to discuss these potential side effects with a healthcare provider to tailor the treatment plan to individual needs.

What prior FDA approvals exist?

The FDA has approved several treatments for stroke, primarily focusing on thrombolytic agents like recombinant tissue plasminogen activator (rt-PA), which is used to dissolve blood clots in acute ischemic stroke. While Maraviroc (Celsentri), a CCR5 antagonist, is being studied for its potential to improve stroke recovery, there are no current FDA-approved CCR5 antagonists specifically for stroke treatment. Broader stroke management includes antiplatelet agents, anticoagulants, and mechanical thrombectomy for eligible patients.

What other types of research exist?

Promising novel alternatives to Maraviroc for stroke patients include: 1) Neuroprotective agents like NA-1 (nerinetide), which has shown potential in reducing brain damage post-stroke. 2) Stem cell therapy, which is being explored for its regenerative capabilities. 3) Advanced rehabilitation techniques such as transcranial magnetic stimulation (TMS) and robotic-assisted therapy, which have shown promise in enhancing motor recovery. Patients should discuss these options with their healthcare provider to determine the best course of action based on their specific condition.

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CCR5 Antagonist

Maraviroc + Exercise for Stroke Recovery (CAMAROS Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for stroke often target the reduction of brain damage and improvement of recovery. Maraviroc, a CCR5 antagonist, works by blocking the CCR5 receptor, which is involved in the inflammatory response and neuronal repair processes. By inhibiting this receptor, Maraviroc may reduce inflammation and promote neural recovery, potentially improving motor function post-stroke. This is crucial for stroke patients as it can enhance rehabilitation outcomes and improve quality of life. Other common treatments include thrombolytics like tPA, which dissolve blood clots to restore blood flow, and antiplatelet agents like aspirin, which prevent new clots from forming. These treatments are essential for minimizing brain damage and preventing further strokes.

Phase 2

Recruiting

Led By Sean Dukelow, MD PhD FRCPC

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- some shoulder abduction with gravity eliminated and visible extension in two or more digits

Age ≥18 years

Must not have

History of renal insufficiency or creatinine clearance (eGFR) < 60mL / min / 1.73m2

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (between 5 days and 8 weeks after stroke), after 8 weeks on drug/placebo, and 6-months post-stroke

Summary

This trial is testing whether the drug Maraviroc, combined with exercise, can help stroke patients recover better. It targets patients shortly after their stroke because recovery often slows down after a few months. Maraviroc might help the brain and nerves heal more effectively when paired with exercise.

Who is the study for?

Adults over 18 with hemiparesis from a recent stroke needing inpatient rehab can join. They must have some arm or leg movement, had an ischemic stroke in the brain's anterior part, and be within 6 weeks post-stroke. Participants need support for daily practice and transport. Exclusions include pre-stroke disability, dementia, certain chronic illnesses including hepatitis or cancer, pregnancy, HIV positivity, specific medication use (e.g., anticonvulsants), and severe kidney issues.

What is being tested?

The CAMAROS trial is testing if Maraviroc (a drug blocking CCR5) combined with exercise helps recovery of arm and leg functions after a stroke compared to placebo. It's randomized: participants are put into groups by chance to receive either Maraviroc or a dummy pill alongside their exercises.

What are the potential side effects?

Maraviroc may cause liver problems, infections due to weakened immune system response, heart issues like irregular heartbeat, digestive disturbances such as stomach pain or diarrhea; allergic reactions; fever; fatigue; coughing; skin rash.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can move my shoulder slightly and extend fingers without gravity.

Select...

I am 18 years old or older.

Select...

I am receiving inpatient rehab for weakness on one side of my body.

Select...

I can move my shoulder slightly without gravity or can visibly move two or more fingers, or I can visibly move my hip.

Select...

I had a stroke affecting the front part of my brain.

Select...

I can move my shoulder slightly without gravity or can visibly move two or more fingers. Or, I can visibly move my hip.

Select...

I can visibly bend and straighten my hip.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My kidney function is reduced with a creatinine clearance rate below 60 mL/min.

Select...

I have a serious condition like Parkinson's or severe injury that was present before a stroke.

Select...

I have epilepsy.

Select...

I had some disability before my stroke.

Select...

I am currently taking Carbamazepine, Phenobarbital, or Phenytoin.

Select...

I have had seizures caused by a stroke.

Select...

I am currently on specific antifungal or antibacterial medications.

Select...

I am currently taking St. John's Wort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (between 5 days and 8 weeks after stroke) and 6-months post-stroke

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (between 5 days and 8 weeks after stroke) and 6-months post-stroke

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (between 5 days and 8 weeks after stroke) and 6-months post-stroke for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in 10-Meter Walk Test Score

Change in Fugl-Meyer Upper Extremity Assessment Score

Secondary study objectives

6 Minute Walk Test

Upper arm

Other study objectives

European Quality of Life Across 5 Domains (EQ-5D)

Fugl-Meyer Lower Extremity Assessment Score

Montreal Cognitive Assessment (MoCA)

+4 more

Side effects data

From 2008 Phase 4 trial • 18 Patients • NCT00666705

Folliculitis

Peripheral neurophathy

Somnolence

Constipation

100%

80%

60%

40%

20%

Study treatment Arm

Maraviroc

Maraviroc + Raltegravir

Raltegravir

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Maraviroc (Celsentri)Experimental Treatment4 Interventions

Maraviroc (Celsentri) will be administered to this group. Participants will be administered a dose of 300mg to be taken twice per day for the duration of the exercise intervention (8 weeks).

Group II: PlaceboPlacebo Group4 Interventions

An over-encapsulated placebo, or "sugar pill" (so it appears identical to the trial drug) will be administered to this group. Participants will be administered the placebo identical to the 300mg maraviroc tablet for the duration of the exercise intervention (8 weeks).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise Program

2016

Completed Phase 4

~5010

Motor Learning

2001

N/A

~40

Maraviroc

2014

Completed Phase 4

~1770

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for stroke often target the reduction of brain damage and improvement of recovery. Maraviroc, a CCR5 antagonist, works by blocking the CCR5 receptor, which is involved in the inflammatory response and neuronal repair processes. By inhibiting this receptor, Maraviroc may reduce inflammation and promote neural recovery, potentially improving motor function post-stroke. This is crucial for stroke patients as it can enhance rehabilitation outcomes and improve quality of life. Other common treatments include thrombolytics like tPA, which dissolve blood clots to restore blood flow, and antiplatelet agents like aspirin, which prevent new clots from forming. These treatments are essential for minimizing brain damage and preventing further strokes.