Ischemic StrokePhase 2MASTERNCT07080567
Manipulating the Peri-Infarct Area Using Maraviroc to Enhance Motor Skills After Stroke
A Phase 2 study testing Maraviroc and Mannitol in people with Ischemic Stroke and Stroke, run by Emmanuel Carrera at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Stroke, Stroke Acute
- What is being tested?
- Maraviroc and Mannitol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Jul 2025to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Geneva University Hospital
Geneva
Nicolas Broc, MD, nicolas.broc@hug.ch
Emmanuel Carrera, MD
About this study
Official title: Maraviroc for Stroke Recovery (MASTER): A Phase 2 Double-Blind Placebo-Controlled Randomized Clinical Trial
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.
Read the 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
- Being tested
- Maraviroc, Mannitol
- Keywords
- Ischemic Stroke, Maraviroc, CCR5, Stroke, Stroke Acute, Motor Recovery, Randomized Controlled Trial
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaravirocDrug
Also called Celsentri
Maraviroc (300mg) twice daily for 90 days
MannitolDrug
Placebo intervention
| Study group | Role | What they receive |
|---|---|---|
| Maraviroc | Active comparator | Maraviroc (Celsentri) 300 mg twice daily Receives: Drug: Maraviroc |
| Placebo | Placebo comparator | Placebo (Mannitol) encapsulated Receives: Drug: Mannitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 90
Secondary outcomes (3)
Motor Learning Score
A motor sequence learning score assessing the capability of the participant to learn a finger tapping sequence of 6 items.
Measured: 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
Measured: 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.
Measured: 0-180 days (inclusive)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start14 Jul 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emmanuel Carrera
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emmanuel Carrera, University Hospital, Geneva
- Investigators
- Emmanuel Carrera, MD, Principal investigator, Hôpitaux Universitaires Genève
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080567
- Sponsor's protocol ID
- 2024-02359
- Other IDs
- 215285
- Acronym
- MASTER
- Status last verified
- Aug 2025
- First submitted
- 2 Jul 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 30794775Sharif 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.
PubMed 40193175Broc N, Byczynski G, Dirren E, Carrera E. Maraviroc for Stroke Recovery (MASTER): protocol for a phase 2 double-blind placebo-controlled randomised clinical trial. BMJ Open. 2026 May 3;16(4):e109554. doi: 10.1136/bmjopen-2025-109554.
PubMed 42082248
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maraviroc for Stroke Recovery (MASTER): A Phase 2 Double-Blind Placebo-Controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07080567
- Acronym / sponsor ID
- MASTER / 2024-02359
- Conditions
- Ischemic Stroke, Stroke, Stroke Acute
- Keywords
- Ischemic Stroke, Maraviroc, CCR5, Stroke, Stroke Acute, Motor Recovery, Randomized Controlled Trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Emmanuel CarreraUniversity, hospital or other
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maraviroc | Active comparator | Drug: MaravirocMaraviroc (Celsentri) 300 mg twice daily |
| Placebo | Placebo comparator | Drug: MannitolPlacebo (Mannitol) encapsulated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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. :
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MaravirocAlso: CelsentriMaraviroc (300mg) twice daily for 90 days | Drug | Maraviroc |
| MannitolPlacebo intervention | Drug | Placebo |
Primary outcome
Upper Extremity Fugl-Meyer Assessment (FMA-UE) Score
Time frame: Day 90
Reliable and validated score of motor function of the upper extremities after stroke. Range: 0-66, higher values indicating better motor function.
3 secondary outcomes
Motor Learning Score
Time frame: Day 0, 90
Number of adverse events (AE) of special interest
Time frame: Day 0-180 (inclusive)
Number of Serious Adverse Events (SAE)
Time frame: 0-180 days (inclusive)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Background: PubMed 30794775Joy 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.
- Background: PubMed 40193175Sharif 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.
- Derived from this study: PubMed 42082248Broc N, Byczynski G, Dirren E, Carrera E. Maraviroc for Stroke Recovery (MASTER): protocol for a phase 2 double-blind placebo-controlled randomised clinical trial. BMJ Open. 2026 May 3;16(4):e109554. doi: 10.1136/bmjopen-2025-109554.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emmanuel Carrera, MD principal investigator
Hôpitaux Universitaires Genève
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Maraviroc and Mannitol in people with Ischemic Stroke and Stroke, run by Emmanuel Carrera at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emmanuel Carrera, MD (+41 (0)22 372 83 18, emmanuel.carrera@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper Extremity Fugl-Meyer Assessment (FMA-UE) Score (time frame: Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07080567, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.