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The Canadian Maraviroc RCT To Augment Rehabilitation Outcomes After Stroke (CAMAROS)

Primary Purpose

Stroke

Status

Recruiting

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Maraviroc

Exercise Program

Placebo

Activity Sensor

Motor Learning

About this trial

This is an interventional treatment trial for Stroke focused on measuring Rehabilitation, Exercise, Maraviroc, Randomized Control Trial, Activity Sensors, Motor Learning, Retention, Wearable Sensors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Primary ischemic anterior circulation stroke
Age ≥18 years
At least 5 days after stroke but within 6 weeks of stroke on the date of medication (maraviroc or placebo) start
Hemiparesis requiring inpatient rehabilitation
Assistance available for daily rehabilitation training practice and for transportation when needed
Adequate language skills to understand the Informed Consent and retain information during daily therapies
At least one of the following:
- some shoulder abduction with gravity eliminated and visible extension in two or more digits OR
- visible hip flexion or extension

Subgroup Stratification Criteria

For Upper Extremity Group:
- Minimum Ability: MRC grade >1 for shoulder abduction AND MRC grade >1 for finger extensor on at least one digit
- Maximum Ability: Upper Extremity Fugl-Meyer Assessment Score >56
For Lower Extremity Group:
- Minimum Ability: requiring a 2-person assist
- Maximum Ability: walking speed <0.8m/s, no visible hip flexion or extension

Exclusion Criteria:

Pre-stroke modified Rankin score ≥ 2
Limited resources or illness that will not enable a return to living outside of a facility
History of dementia
History of hepatitis or elevated hepatic transaminases or bilirubin
History of renal insufficiency or creatinine clearance (eGFR) < 60mL / min / 1.73m2
Cancer or other chronic illness that makes 1-year survival unlikely or will detract from the ability to carry out exercise and skills practice
Existing pre-stroke serious disabling disease (e.g., Parkinson's disease, severe traumatic brain injury, amputation)
Seizure related to stroke
Acute or chronic epilepsy
Currently taking any of the following anticonvulsant medications:
- Carbamazepine
- Phenobarbital
- Phenytoin
Pregnant, breastfeeding, or positive test for pregnancy at baseline
Women of childbearing potential who are not using one highly effective form of contraception or two forms of effective contraception
Known HIV positivity
Currently taking any of the following antifungal and/or antibacterial medications:
- Ketoconazole
- Itraconazole
- Voriconazole
- Rifampin
- Clarithromycin
- Rifabutin + Protease Inhibitor

14. Currently taking St. John's Wort

Sites / Locations

University of Calgary & Foothills Medical CentreRecruiting
University of British Columbia & GF Strong Rehabilitation Centre
Memorial University of Newfoundland
Dalhousie University
Parkwood Institute
Sunnybrook Health Sciences Centre
Toronto Rehabilitation Institute - University Health Network

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Maraviroc (Celsentri)

Placebo

Arm Description

Maraviroc (Celsentri) will be administered to this group. Participants will be administered a dose of 300mg to be taken twice per day for the duration of the exercise intervention (8 weeks).

An over-encapsulated placebo, or "sugar pill" (so it appears identical to the trial drug) will be administered to this group. Participants will be administered the placebo identical to the 300mg maraviroc tablet for the duration of the exercise intervention (8 weeks).

Outcomes

Primary Outcome Measures

Change in Fugl-Meyer Upper Extremity Assessment Score

Difference in subscale scores on the Upper-Extremity Fugl-Meyer Assessment - both motor (max 66) and sensory (max 12) components. Higher scores indicate better outcome.

Change in 10-Meter Walk Test Score

A performance measure used to assess walking speed in meters per second over a short distance. It can be used to determine functional mobility, gait, and vestibular function. Faster speed indicates better function.

Secondary Outcome Measures

Action Research Arm Test (ARAT)

The ARAT assesses arm function to determine the quality of the arm movement, and the limitation of activity. The ARAT consists of 4 sub-tests; that examines and individual's grip, grasp, pinch and gross motor movement in order to determine upper extremity function. Objects of varying size, shape, and weight must be either grasped, handled or moved in a specific task in order to evaluate function. Low scores mean worse function with the minimum possible score being 0 and the highest possible score being 57 (normal function).

6 Minute Walk Test

An assessment of ambulatory function by measuring the distance walked over a period of 6 minutes. Greater distance walked indicates better function.

Full Information

NCT ID

NCT04789616

First Posted

March 5, 2021

Last Updated

January 18, 2023

Sponsor

University of Calgary

Collaborators

University Health Network, Toronto, University of California, Los Angeles, Sunnybrook Health Sciences Centre, University of British Columbia, Memorial University of Newfoundland, Dalhousie University, Parkwood Hospital, London, Ontario, Riverview Health Centre Foundation, The Dr. Miriam and Sheldon G. Adelson Medical Research Foundation

1. Study Identification

Unique Protocol Identification Number

NCT04789616

Brief Title

The Canadian Maraviroc RCT To Augment Rehabilitation Outcomes After Stroke

Acronym

CAMAROS

Official Title

The CAMAROS Trial: The Canadian Maraviroc RCT To Augment Rehabilitation Outcomes After Stroke

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 15, 2022 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Calgary

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The CAMAROS trial is a randomized controlled phase II trial analyzing the effect of coupling a C-C chemokine receptor 5 (CCR5) antagonist, Maraviroc (Celsentri), and exercise to improve both upper and lower extremity recovery after a stroke.

Detailed Description

After stroke, the combination of progressive skills practice in an adequate dose plus exercise for fitness augments motor and cognitive outcomes. However, sensorimotor and cognitive improvements often plateau after 12 weeks. There is an urgent need to find novel methods to drive recovery and lessen limb paralysis. Drugs that might enhance learning or neural repair, as well as other molecular and synaptic adaptations that occur during skills training and fitness exercise, might extend that recovery curve, although to date only fluoxetine has given any hint of this. Most trials have tested agents that modulate neurotransmitters. Several very recent preclinical experiments and observational studies in patients after stroke suggest that the commercially available medication, Maraviroc, may augment skills learning during rehabilitation training especially during the first three months after onset, by acting on unique molecular components for novel learning. The CAMAROS trial is a randomized, placebo-controlled, blinded phase II trial evaluating the efficacy of coupling Maraviroc (Celsentri) with exercise rehabilitation across multiple Canadian sites in 120 stroke participants. Patients will begin their participation within 6 weeks of stroke onset. Both groups will receive an exercise program in addition to standard of care rehabilitation, but only one group (the intervention group) will receive the active drug Maraviroc. Study participants will be evaluated using physical assessments, cognitive assessments, and using wrist and ankle activity sensors at baseline, after 4 weeks of taking the drug/placebo, after 8 weeks of taking the drug/placebo, and at 6-months post-stroke. While enrolled in the study, participants will be required to take part in an 8 week, daily exercise program. Participants will also perform a short motor learning assessment at each formal assessment and again within 24 hours of each formal assessment (initial test and 24-hour retention test). Evaluators and participants will be blind to the treatment administered. The trial is constructed with randomization to remove selection and allocation biases and to ensure greater validity in observed differences in the outcome measures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

Rehabilitation, Exercise, Maraviroc, Randomized Control Trial, Activity Sensors, Motor Learning, Retention, Wearable Sensors

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Maraviroc (Celsentri)

Arm Type

Experimental

Arm Description

Maraviroc (Celsentri) will be administered to this group. Participants will be administered a dose of 300mg to be taken twice per day for the duration of the exercise intervention (8 weeks).

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Maraviroc

Other Intervention Name(s)

Celsentri

Intervention Description

Half of the participants will take maraviroc for a period of 8 weeks.

Intervention Type

Behavioral

Intervention Name(s)

Exercise Program

Intervention Description

All participants will take part in an 8-week exercise program. While in-hospital, participants will undergo standard of care rehabilitation (estimated at 45 minutes each daily for PT & OT) plus a supplementary upper extremity exercise program (Graded Repetitive Arm Supplementary Program (GRASP); estimated at 1 hour daily). After discharge from inpatient care, participants will complete an at-home supplementary upper and lower extremity exercise program. This program will include 30 minutes daily walking or sit-to-stand exercises and 30 minutes daily practice using the GRASP program.

Intervention Type

Other

Intervention Name(s)

Placebo

Other Intervention Name(s)

"Sugar" Pill

Intervention Description

Half of the participants will take a placebo for a period of 8 weeks.

Intervention Type

Device

Intervention Name(s)

Activity Sensor

Intervention Description

Participants will be asked to wear small activity sensors (one on each wrist and one on each ankle, total of four sensors) at the baseline, 4-week, 8-week, and 6-month assessments for 7 consecutive days. Activity related to walking, sleep, physical activity, and arm and leg movement throughout the day will be measured. The sensors will be worn for a total of 28 days throughout the study.

Intervention Type

Behavioral

Intervention Name(s)

Motor Learning

Intervention Description

Participants will be asked to perform a computer-based motor learning assessment at the baseline, 4-week, 8-week, and 6-month assessments. A retention task, which involves shorter versions of the initial tasks, will also be completed within 24 hours of the initial assessment (initial test and 24-hour retention test).

Primary Outcome Measure Information:

Title

Change in Fugl-Meyer Upper Extremity Assessment Score

Description

Difference in subscale scores on the Upper-Extremity Fugl-Meyer Assessment - both motor (max 66) and sensory (max 12) components. Higher scores indicate better outcome.

Time Frame

Baseline (between 5 days and 6 weeks after stroke), after 4 weeks on drug/placebo, after 8 weeks on drug/placebo, and 6-months post-stroke

Title

Change in 10-Meter Walk Test Score

Description

Time Frame

Baseline (between 5 days and 6 weeks after stroke), after 4 weeks on drug/placebo, after 8 weeks on drug/placebo, and 6-months post-stroke

Secondary Outcome Measure Information:

Title

Action Research Arm Test (ARAT)

Description

Time Frame

Baseline (between 5 days and 6 weeks after stroke), after 4 weeks on drug/placebo, after 8 weeks on drug/placebo, and 6-months post-stroke

Title

6 Minute Walk Test

Description

An assessment of ambulatory function by measuring the distance walked over a period of 6 minutes. Greater distance walked indicates better function.

Time Frame

Baseline (between 5 days and 6 weeks after stroke), after 4 weeks on drug/placebo, after 8 weeks on drug/placebo, and 6-months post-stroke

Other Pre-specified Outcome Measures:

Title

Fugl-Meyer Lower Extremity Assessment Score

Description

Fugl-Meyer Lower Extremity Assessment assesses motor and sensorimotor impairment in the lower extremities. Total score is between 0 and 34. Sub-scales include: proximal (0-18), knee/ankle (0-10) and coordination/speed (0-6). Higher scores indicate better performance. Sub-scale scores are summed to calculate total score.

Time Frame

Baseline (between 5 days and 6 weeks after stroke), after 4 weeks on drug/placebo, after 8 weeks on drug/placebo, and 6-months post-stroke

Title

Patient Health Questionnaire 9 (PHQ-9)

Description

A 9-question measurement used to screen for the presence and severity of depression.

Time Frame

Baseline (between 5 days and 6 weeks after stroke), after 8 weeks on drug/placebo, and 6-months post-stroke

Title

Stroke Aphasia Depression Questionnaire (SADQ)

Description

A 10-item questionnaire completed by a caregiver to quickly assess depressive symptoms in stroke patients with aphasia. Higher scores indicate a greater likelihood of depression.

Time Frame

BaselineBaseline (between 5 days and 6 weeks after stroke), after 8 weeks on drug/placebo, and 6-months post-stroke, 8-week assessment, and 6-month assessment

Title

European Quality of Life Across 5 Domains (EQ-5D)

Description

A self-completion questionnaire used to assess health-related quality of life.

Time Frame

Baseline (between 5 days and 6 weeks after stroke), after 8 weeks on drug/placebo, and 6-months post-stroke

Title

Stroke Impact Scale (SIS)

Description

Stroke-specific, self-report, health status measure. Assesses multiple domains on a 5-point Likert scale. Domains include: strength (4-20), hand function (5-25), activities of daily living/instrumental activities of daily living (10-50), mobility (9-45), communication (7-35), emotion (9-45), memory and thinking (7-35), and participation (8-40). An extra question asks that the patient rate on a scale from 0 - 100 how much they feel that he/she has recovered from his/her stroke. The 4 physical domains (strength, hand function, mobility and activities of daily living) can be summed together to create a single, physical dimension score (28-140) while all other domains should remain separate. Higher scores indicate better function.

Time Frame

Baseline (between 5 days and 6 weeks after stroke), after 8 weeks on drug/placebo, and 6-months post-stroke

Title

National Institutes of Health Stroke Scale (NIHSS)

Description

A 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Higher scores indicate greater impairment.

Time Frame

Baseline (between 5 days and 6 weeks after stroke) and 6-months post-stroke

Title

Montreal Cognitive Assessment (MoCA)

Description

A cognitive screening test used to assess: short term memory, visuospatial abilities, executive functions, attention, concentration, working memory, language, and orientation to time and place. Higher scores indicate better function.

Time Frame

Baseline (between 5 days and 6 weeks after stroke) and 6-months post-stroke

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Primary ischemic anterior circulation stroke Age ≥18 years At least 5 days after stroke but within 6 weeks of stroke on the date of medication (maraviroc or placebo) start Hemiparesis requiring inpatient rehabilitation Assistance available for daily rehabilitation training practice and for transportation when needed Adequate language skills to understand the Informed Consent and retain information during daily therapies At least one of the following: some shoulder abduction with gravity eliminated and visible extension in two or more digits OR visible hip flexion or extension Subgroup Stratification Criteria For Upper Extremity Group: Minimum Ability: MRC grade >1 for shoulder abduction AND MRC grade >1 for finger extensor on at least one digit Maximum Ability: Upper Extremity Fugl-Meyer Assessment Score >56 For Lower Extremity Group: Minimum Ability: requiring a 2-person assist Maximum Ability: walking speed <0.8m/s, no visible hip flexion or extension Exclusion Criteria: Pre-stroke modified Rankin score ≥ 2 Limited resources or illness that will not enable a return to living outside of a facility History of dementia History of hepatitis or elevated hepatic transaminases or bilirubin History of renal insufficiency or creatinine clearance (eGFR) < 60mL / min / 1.73m2 Cancer or other chronic illness that makes 1-year survival unlikely or will detract from the ability to carry out exercise and skills practice Existing pre-stroke serious disabling disease (e.g., Parkinson's disease, severe traumatic brain injury, amputation) Seizure related to stroke Acute or chronic epilepsy Currently taking any of the following anticonvulsant medications: Carbamazepine Phenobarbital Phenytoin Pregnant, breastfeeding, or positive test for pregnancy at baseline Women of childbearing potential who are not using one highly effective form of contraception or two forms of effective contraception Known HIV positivity Currently taking any of the following antifungal and/or antibacterial medications: Ketoconazole Itraconazole Voriconazole Rifampin Clarithromycin Rifabutin + Protease Inhibitor 14. Currently taking St. John's Wort

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alexandra McKinnon

Phone

403-944-4050

alexandra.mckinnon@ucalgary.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Mark Piitz

Phone

403-944-4050

mapiitz@ucalgary.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sean Dukelow, MD PhD FRCPC

Organizational Affiliation

University of Calgary, Calgary, Alberta, Canada

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Bruce Dobkin, MD

Organizational Affiliation

University of California, Los Angeles, California, USA

Official's Role

Study Chair

Facility Information:

Facility Name

University of Calgary & Foothills Medical Centre

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 2T9

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alexandra McKinnon

Phone

403-944-4050

alexandra.mckinnon@ucalgary.ca

First Name & Middle Initial & Last Name & Degree

Mark Piitz

Phone

403-944-4050

mapiitz@ucalgary.ca

First Name & Middle Initial & Last Name & Degree

Gentson Leung, MD

Facility Name

University of British Columbia & GF Strong Rehabilitation Centre

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 2G9

Country

Canada

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Courtney Pollock

Phone

604-827-1631

courtney.pollock@ubc.ca

First Name & Middle Initial & Last Name & Degree

Janice Eng, PhD

First Name & Middle Initial & Last Name & Degree

Courtney Pollock, PhD

First Name & Middle Initial & Last Name & Degree

Jennifer Yao, MD

Facility Name

Memorial University of Newfoundland

City

Saint John's

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1A 1E5

Country

Canada

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ganesh Melam

Phone

709-777-2082

grmelam@mun.ca

First Name & Middle Initial & Last Name & Degree

Michelle Ploughman, PhD

First Name & Middle Initial & Last Name & Degree

Jason McCarthy, MD

Facility Name

Dalhousie University

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 3J5

Country

Canada

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Melanie Dunlop

Phone

902-473-1401

Melanie.Dunlop@nshealth.ca

First Name & Middle Initial & Last Name & Degree

Marilyn Mackay-Lyons, PhD

First Name & Middle Initial & Last Name & Degree

Anita Mountain, MD

Facility Name

Parkwood Institute

City

London

State/Province

Ontario

ZIP/Postal Code

N6C 0A7

Country

Canada

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alexandria Roa Agudelo

Alexandria.RoaAgudelo@sjhc.london.on.ca

First Name & Middle Initial & Last Name & Degree

Robert Teasell, MD

Facility Name

Sunnybrook Health Sciences Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ellen Cohen

Phone

416-480-6100

Ext

85406

ecohen@sri.utoronto.ca

First Name & Middle Initial & Last Name & Degree

Bradley MacIntosh, PhD

First Name & Middle Initial & Last Name & Degree

Sandra Black, MD

Facility Name

Toronto Rehabilitation Institute - University Health Network

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2A2

Country

Canada

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Evan Foster

Phone

416-597-3422

Ext

3362

Evan.Foster@uhn.ca

First Name & Middle Initial & Last Name & Degree

Mark Bayley, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22044517

Citation

Ben Assayag E, Korczyn AD, Giladi N, Goldbourt U, Berliner AS, Shenhar-Tsarfaty S, Kliper E, Hallevi H, Shopin L, Hendler T, Baashat DB, Aizenstein O, Soreq H, Katz N, Solomon Z, Mike A, Usher S, Hausdorff JM, Auriel E, Shapira I, Bornstein NM. Predictors for poststroke outcomes: the Tel Aviv Brain Acute Stroke Cohort (TABASCO) study protocol. Int J Stroke. 2012 Jun;7(4):341-7. doi: 10.1111/j.1747-4949.2011.00652.x. Epub 2011 Nov 2.

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Citation

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Citation

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Duncan PW, Sullivan KJ, Behrman AL, Azen SP, Wu SS, Nadeau SE, Dobkin BH, Rose DK, Tilson JK, Cen S, Hayden SK; LEAPS Investigative Team. Body-weight-supported treadmill rehabilitation after stroke. N Engl J Med. 2011 May 26;364(21):2026-36. doi: 10.1056/NEJMoa1010790.

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Links:

URL

https://viivhealthcare.com/content/dam/cf-viiv/viiv-healthcare/en_CA/pdf/celsentri.pdf.pdf

Description

Product Monograph for Celsentri (Maraviroc)

Learn more about this trial

The Canadian Maraviroc RCT To Augment Rehabilitation Outcomes After Stroke

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