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

NCT ID: NCT07080567

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-14
• Study Completion Date: 2027-12-31

Brief 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.

Detailed Description

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.

Conditions

Ischemic Stroke; Stroke; Stroke Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Maraviroc

Maraviroc (Celsentri) 300 mg twice daily

Group Type: ACTIVE_COMPARATOR

Maraviroc

Intervention Type: DRUG

Maraviroc (300mg) twice daily for 90 days

Placebo

Placebo (Mannitol) encapsulated

Group Type: PLACEBO_COMPARATOR

Mannitol

Intervention Type: DRUG

Placebo intervention

Interventions

Maraviroc

Maraviroc (300mg) twice daily for 90 days

Intervention Type: DRUG

Mannitol

Placebo intervention

Intervention Type: DRUG

Other Intervention Names

Celsentri

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emmanuel Carrera

OTHER

Sponsor Role: lead

Responsible Party

Emmanuel Carrera

Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Emmanuel Carrera, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux Universitaires Genève

Locations

Geneva University Hospital

Geneva, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Emmanuel Carrera, MD

Role: CONTACT

emmanuel.carrera@hug.ch

+41 (0)22 372 83 18

Nicolas Broc, MD

Role: CONTACT

nicolas.broc@hug.ch

+41 (0)79 553 38 37

Facility Contacts

Nicolas Broc, MD

Role: primary

nicolas.broc@hug.ch

References

Joy MT, Ben Assayag E, Shabashov-Stone D, Liraz-Zaltsman S, Mazzitelli J, Arenas M, Abduljawad N, Kliper E, Korczyn AD, Thareja NS, Kesner EL, Zhou M, Huang S, Silva TK, Katz N, Bornstein NM, Silva AJ, Shohami E, Carmichael ST. CCR5 Is a Therapeutic Target for Recovery after Stroke and Traumatic Brain Injury. Cell. 2019 Feb 21;176(5):1143-1157.e13. doi: 10.1016/j.cell.2019.01.044.

Reference Type: BACKGROUND

PMID: 30794775 (View on PubMed)

Sharif A, Jeffers MS, Fergusson DA, Bapuji R, Nicholls SG, Humphrey J, Johnston W, Mitchell E, Speirs MA, Stronghill L, Vuckovic M, Wulf S, Shorr R, Dowlatshahi D, Corbett D, Lalu MM. Preclinical systematic review of CCR5 antagonists as cerebroprotective and stroke recovery enhancing agents. Elife. 2025 Apr 7;14:RP103245. doi: 10.7554/eLife.103245.

Reference Type: BACKGROUND

PMID: 40193175 (View on PubMed)

Other Identifiers

215285

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024-02359

Identifier Type: -

Identifier Source: org_study_id