Maraviroc to improve arm and hand movement after ischemic stroke
Maraviroc for Stroke Recovery (MASTER): A Phase 2 Double-Blind Placebo-Controlled Randomized Clinical Trial
This trial will test whether maraviroc, started soon after ischemic stroke, helps people with partial arm weakness regain motor skills over the first three months.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Geneva Academic / other |
| Locations | 1 site (Geneva) |
| Trial ID | NCT07080567 on ClinicalTrials.gov |
What this trial studies
MASTER is a single-center, double-blind, randomized, placebo-controlled phase II trial enrolling 80 adults with recent ischemic stroke and incomplete unilateral upper-limb paresis. Participants are randomized to receive maraviroc or placebo daily for 90 days, starting within five days of stroke onset, and are followed with clinical motor tests, biometrics, and brain imaging at baseline, day 90, and at six months. The trial measures motor function and motor learning with standardized scales and performance tests and collects imaging to relate clinical changes to infarct size and neuroplasticity. The design tests whether CCR5 antagonism can reduce infarct-related damage and enhance recovery when combined with usual care.
Who should consider this trial
Good fit: Adults (≥18) with acute ischemic stroke within five days of onset, unilateral incomplete upper-limb paresis (FMA-UE <63) and residual voluntary finger extension >10°, who can give informed consent and attend follow-up visits are ideal candidates.
Not a fit: Patients unlikely to benefit include those with pre-stroke disability (mRS >2), other diseases affecting motor function (e.g., Parkinson's, ALS), complete paralysis without finger extension, significant liver or renal disease, pregnancy, or inability to attend the single-center visits.
Why it matters
Potential benefit: If successful, maraviroc could improve arm and hand function after stroke and increase independence in daily activities.
How similar studies have performed: Maraviroc and other CCR5 antagonists have shown behavioral and neuroplasticity benefits in animal stroke models, but human clinical evidence is limited and this randomized trial is among the first to test the approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Geneva
- Geneva University Hospital — Geneva, Switzerland (Recruiting)
Study contacts
- Principal investigator: Emmanuel Carrera, MD — Hôpitaux Universitaires Genève
- Study coordinator: Emmanuel Carrera, MD
- Email: emmanuel.carrera@hug.ch
- Phone: +41 (0)22 372 83 18
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.