NCT07080567

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
19mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Jul 2025Dec 2027

First Submitted

Initial submission to the registry

July 2, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

July 14, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 23, 2025

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

2.4 years

First QC Date

July 2, 2025

Last Update Submit

August 7, 2025

Conditions

Ischemic StrokeStrokeStroke Acute

Keywords

Ischemic StrokeMaravirocCCR5StrokeStroke AcuteMotor RecoveryRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Upper 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.

    Day 90

Secondary Outcomes (3)

  • Motor Learning Score

    Day 0, 90

  • Number of adverse events (AE) of special interest

    Day 0-180 (inclusive)

  • Number of Serious Adverse Events (SAE)

    0-180 days (inclusive)

Other Outcomes (10)

  • 9-hole Peg Test (Time)

    Day 0, 30, 60, 90, and 180.

  • Pinch force

    Day 0, 30, 60, 90, and 180.

  • Grip strength

    Day 0, 30, 60, 90, and 180.

  • +7 more other outcomes

Study Arms (2)

Maraviroc

ACTIVE COMPARATOR

Maraviroc (Celsentri) 300 mg twice daily

Drug: Maraviroc

Placebo

PLACEBO COMPARATOR

Placebo (Mannitol) encapsulated

Drug: Mannitol

Interventions

MaravirocDRUG

Maraviroc (300mg) twice daily for 90 days

Also known as: Celsentri
Maraviroc
MannitolDRUG

Placebo intervention

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geneva University Hospital

Geneva, Switzerland

RECRUITING

Related Publications (2)

  • 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.

    PMID: 30794775BACKGROUND

  • 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.

    PMID: 40193175BACKGROUND

MeSH Terms

Conditions

Ischemic StrokeStroke

Interventions

MaravirocMannitol

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsSugar AlcoholsAlcoholsCarbohydrates

Study Officials

  • Emmanuel Carrera, MD

    Hôpitaux Universitaires Genève

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmanuel Carrera, MD

CONTACT

+41 (0)22 372 83 18emmanuel.carrera@hug.ch

Nicolas Broc, MD

CONTACT

+41 (0)79 553 38 37nicolas.broc@hug.ch

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-Investigator

Study Record Dates

First Submitted

July 2, 2025

First Posted

July 23, 2025

Study Start

July 14, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

August 12, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

Anonymized patient data of the primary and secondary study outcomes (FMA-UE, global functioning scores, motor learning scores) are currently anticipated to be shared dependent on participant consent to data sharing.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
The IPD and supporting information will be available following the publication of the results (est. 2028) and will be available indefinitely.
Access Criteria
IPD will be available in a de-identified format to ensure participant confidentiality. Access will be granted to qualified researchers upon reasonable request, subject to prior approval by the sponsor and the demonstration of approval from a competent ethics committee. The shared data will include de-identified IPD that underlies the results reported in the publication (text, tables, figures, and appendices). Supporting documents such as the study protocol, statistical analysis plan, and clinical study report may also be available. Data will be accessible through a secure platform or via direct request after publication of the main study results.

Locations

CH(1)