RecruitingPhase 2NCT07080567
Manipulating the Peri-Infarct Area Using Maraviroc to Enhance Motor Skills After Stroke
Maraviroc for Stroke Recovery (MASTER): A Phase 2 Double-Blind Placebo-Controlled Randomized Clinical Trial
Sponsor
Emmanuel Carrera
Enrollment
80 participants
Start Date
Jul 14, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
MASTER is a single-center, patient and investigator-blinded, Randomized Controlled Trial (RCT) to compare the efficacy of Maraviroc, a C-C chemokine receptor 5 (CCR5) antagonist, against placebo regarding motor function and motor learning skills in the first 3 months after ischemic stroke.
Eligibility
Min Age: 18 Years
Inclusion Criteria7
- Informed consent as documented by signature
- ≥18 years at time of signing of informed consent
- Acute ischemic stroke.
- Stroke onset < 7 days from randomization.
- Contralateral, unilateral, incomplete upper limb paresis, incl. :
- FMA-UE < 63/66
- Residual voluntary finger extension (VFE) of > 10 degrees
Exclusion Criteria11
- Pregnancy/lactation or positive pregnancy test in women of childbearing age
- Pre-stroke handicap (mRS > 2)
- Diseases affecting motor function (e.g., Parkinson's Disease, Amyotrophic Lateral Sclerosis (ALS))
- Participation in another study with investigational medicinal product within 30 days preceding and during the present study
- Enrolment of the investigator, his/her family members, employees, or other dependent persons
- Known hypersensitivity to Maraviroc, Mannitol, peanuts, or soy
- History of significant liver disease, hepatitis, elevated liver function tests (> 1.5 upper limit of normal)
- History of significant renal disease or End Stage Renal Disease/dialysis, acute renal injury, Creatinine Clearance (CrCl < 30ml/min/1.73m2)
- Patients with cardiovascular comorbidities and risk for orthostatic hypotension
- HIV infection
- Concomitant use of strong CYP3A4 inhibitors or inducers
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Interventions
DRUGMaraviroc
Maraviroc (300mg) twice daily for 90 days
DRUGMannitol
Placebo intervention
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07080567
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