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.
Stroke is a common disease and one of the leading causes of death and disability worldwide. Despite advances in acute stroke therapies (intravenous thrombolysis and/or mechanical thrombectomy), deficits remain frequent after stroke. Pharmacological approaches have the benefit of being independent of patient participation, are easily administered, and involve limited medical resources. Unfortunately, the efficacy of several drugs that improve behavioural in preclinical models have yet to be confirmed in humans. Maraviroc, a C-C chemokine receptor 5 (CCR5) antagonist has shown promise in preclinical models, and instead of targeting neurotransmitters, is believed to augment rehabilitation by decreasing infarct size, increasing neuroplasticity, and most importantly, improving behaviour. The MASTER trial is a single-center, double-blinded, randomized placebo-controlled, phase II clinical trial designed to evaluate the efficacy of Maraviroc (Celsentri) compared to a placebo, in improving outcomes following ischemic stroke in the early stage of recovery. 80 patients will be recruited within 5 days of stroke onset, and will receive either Maraviroc or a placebo drug for 90 days. Participants will be assessed using a combination of clinical measurements, motor tests, and biometrics throughout the 90 days of intervention, and upon follow-up at 6-months post stroke onset. Several types of brain images will be obtained before and after the intervention period (day 0 and day 90), and participants will also perform a motor learning task before and after the intervention period (day 0 and day 90). Study personnel and participants will be blinded to the treatment, which will be randomly assigned to an intervention group with stratification based on side of the infarct and motor deficit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Geneva University Hospital
Geneva, Switzerland
RECRUITINGUpper Extremity Fugl-Meyer Assessment (FMA-UE) Score
Reliable and validated score of motor function of the upper extremities after stroke. Range: 0-66, higher values indicating better motor function.
Time frame: Day 90
Motor Learning Score
A motor sequence learning score assessing the capability of the participant to learn a finger tapping sequence of 6 items.
Time frame: Day 0, 90
Number of adverse events (AE) of special interest
The number of patients experiencing AE of special interest : MACE (Major Adverse Cardiovascular Events) - Acute myocardial infarction ; Acute coronary syndrome ; Stroke ; Heart failure ; All cause death ; Cardiovascular death ; Revascularization AND any liver adverse events AND any infection adverse events. Assesed by: CTCAE v5.0
Time frame: Day 0-180 (inclusive)
Number of Serious Adverse Events (SAE)
Number of any SAEs occuring during the study follow-up. Assessed by: CTCAE v5.0.
Time frame: 0-180 days (inclusive)
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