Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID07080567

Maraviroc for Stroke Recovery (MASTER): A Phase 2 Double-Blind Placebo-Controlled Randomized Clinical Trial

Led by Emmanuel Carrera · Updated on 2025-08-12

80

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of Maraviroc, a drug that blocks the CCR5 receptor, to see if it can improve motor function and learning skills in patients during the first three months after an ischemic stroke. This phase II randomized controlled trial compares Maraviroc to a placebo in patients who have recently experienced a stroke, aiming to enhance recovery where current stroke treatments still leave many with lasting disabilities. Participants will be randomly assigned to receive either Maraviroc at a dose of 300 mg twice daily or a placebo (Mannitol) for 90 days. The study is double-blinded, meaning neither the patients nor the researchers know who is receiving the active drug or placebo. Brain images and motor learning tasks will be conducted at the start and end of the treatment period to assess changes. Throughout the 90-day treatment, patients will undergo clinical evaluations, motor tests, and biometric assessments. Follow-up continues at six months after stroke onset to monitor progress. The primary outcome measured is the Upper Extremity Fugl-Meyer Assessment score on day 90, which evaluates motor function recovery. Safety will be monitored by recording adverse events during and after treatment.

CONDITIONS

Brief Title

Manipulating the Peri-Infarct Area Using Maraviroc to Enhance Motor Skills After Stroke

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent
  • 18 years or older at the time of consent
  • Acute ischemic stroke
  • Stroke onset less than 7 days before randomization
  • Unilateral incomplete upper limb weakness with FMA-UE score less than 63/66
  • Residual voluntary finger extension greater than 10 degrees
Not Eligible

You will not qualify if you...

  • Pregnancy, breastfeeding, or positive pregnancy test in women of childbearing age
  • Pre-stroke handicap with modified Rankin Scale greater than 2
  • Diseases affecting motor function such as Parkinson's Disease or ALS
  • Participation in another investigational drug study within 30 days before or during this study
  • Investigator or related persons enrolled in the study
  • Known allergy to Maraviroc, Mannitol, peanuts, or soy
  • Significant liver disease or elevated liver tests above 1.5 times the upper normal limit
  • Significant kidney disease or creatinine clearance below 30 ml/min/1.73m2
  • Cardiovascular conditions with risk of orthostatic hypotension
  • HIV infection
  • Use of strong CYP3A4 inhibitors or inducers

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 90 days

Participants receive Maraviroc or a placebo twice daily to improve recovery after ischemic stroke.

Regular assessments throughout the 90 days of intervention

Follow-up

Duration - Approximately 3 months after treatment ends

Participants are assessed 6 months after stroke onset to evaluate long-term outcomes.

1 follow-up visit (in-person) at 6 months post stroke onset

Trial Site Locations

Total: 1 location

1

Geneva University Hospital

Geneva, Switzerland

Actively Recruiting

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Research Team

E

Emmanuel Carrera, MD

N

Nicolas Broc, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Maraviroc for Stroke Recovery (MASTER): protocol for a phase 2 double-blind placebo-controlled randomised clinical trial.

Nicolas Broc, Gabriel Byczynski, Elisabeth Dirren...

https://pubmed.ncbi.nlm.nih.gov/42082248