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CCR5 Antagonist

Maraviroc + Exercise for Stroke Recovery (CAMAROS Trial)

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
Awards & highlights

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
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I can move my shoulder slightly and extend fingers without gravity.
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I am 18 years old or older.
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I am receiving inpatient rehab for weakness on one side of my body.
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I can move my shoulder slightly without gravity or can visibly move two or more fingers, or I can visibly move my hip.
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I had a stroke affecting the front part of my brain.
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I can move my shoulder slightly without gravity or can visibly move two or more fingers. Or, I can visibly move my hip.
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I can visibly bend and straighten my hip.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidney function is reduced with a creatinine clearance rate below 60 mL/min.
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I have a serious condition like Parkinson's or severe injury that was present before a stroke.
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I have epilepsy.
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I had some disability before my stroke.
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I am currently taking Carbamazepine, Phenobarbital, or Phenytoin.
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I have had seizures caused by a stroke.
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I am currently on specific antifungal or antibacterial medications.
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I am currently taking St. John's Wort.

Timeline

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
6%
Folliculitis
6%
Constipation
6%
Peripheral neurophathy
6%
Somnolence
100%
80%
60%
40%
20%
0%
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 3
~4930
Motor Learning
2001
N/A
~40
Maraviroc
2014
Completed Phase 4
~1770

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.

Find a Location

Who is running the clinical trial?

Parkwood Hospital, London, OntarioOTHER
6 Previous Clinical Trials
568 Total Patients Enrolled
3 Trials studying Stroke
463 Patients Enrolled for Stroke
Riverview Health Centre FoundationOTHER
5 Previous Clinical Trials
245 Total Patients Enrolled
1 Trials studying Stroke
52 Patients Enrolled for Stroke
Memorial University of NewfoundlandOTHER
69 Previous Clinical Trials
1,835,709 Total Patients Enrolled
1 Trials studying Stroke
52 Patients Enrolled for Stroke

Media Library

Maraviroc (CCR5 Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04789616 — Phase 2
Stroke Research Study Groups: Maraviroc (Celsentri), Placebo
Stroke Clinical Trial 2023: Maraviroc Highlights & Side Effects. Trial Name: NCT04789616 — Phase 2
Maraviroc (CCR5 Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04789616 — Phase 2
~44 spots leftby Dec 2025
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