StrokePhase 2CAMAROSNCT04789616
The Canadian Maraviroc Randomized Controlled Trial To Augment Rehabilitation Outcomes After Stroke
A Phase 2 study testing Maraviroc, Exercise Program and Activity Sensor in people with Stroke, run by University of Calgary at 6 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Maraviroc, Exercise Program and Activity Sensor
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 6 sitesCanada
- Study dates
- 15 Sep 2022to Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Primary ischemic anterior circulation stroke
- Age ≥18 years
- At least 5 days after stroke but within 8 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
Show all 16Show fewer
- 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: Medical Research Council (MRC) grade >1 for shoulder abduction AND MRC grade >1 for finger extensor on at least two digits
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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
- Currently taking St. John's Wort
- Currently taking Paxlovid
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites, 6 recruiting
- Recruiting
University of Calgary & Foothills Medical Centre
Calgary, Alberta, T2N 2T9
Alexandra McKinnon, 403-944-4050, alexandra.mckinnon@ucalgary.ca
Mark Piitz, 403-944-4050, mapiitz@ucalgary.ca
- Recruiting
Dalhousie University
Halifax, Nova Scotia, B3H 3J5
Melanie Dunlop, 902-473-1401, Melanie.Dunlop@nshealth.ca
Marilyn Mackay-Lyons, PhD
- Recruiting
Parkwood Institute
London, Ontario, N6C 0A7
Shiela Geniblazo, Shiela.Geniblazo@sjhc.london.on.ca
Robert Teasell, MD
- Not yet recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Olga Yaroslavtseva, olga.yaroslavtseva@uhn.ca
Bradley MacIntosh, PhD
- Not yet recruiting
Toronto Rehabilitation Institute - University Health Network
Toronto, Ontario, M5G 2A2
Olga Yaroslavtseva, 416-597-3422 ext. 3362, olga.yaroslavtseva@uhn.ca
Mark Bayley, MD
- Recruiting
University of British Columbia & GF Strong Rehabilitation Centre
Vancouver, British Columbia, V5Z 2G9
Courtney Pollock, 604-827-1631, courtney.pollock@ubc.ca
Janice Eng, PhD
About this study
Official title: The CAMAROS Trial: The Canadian Maraviroc Randomized Controlled Trial To Augment Rehabilitation Outcomes After Stroke
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.
Read the 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 8 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 72 hours of each formal assessment (initial test and 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.
- Conditions
- Stroke
- Being tested
- Maraviroc, Exercise Program, Placebo, Activity Sensor, Motor Learning
- Keywords
- Rehabilitation, Exercise, Maraviroc, Randomized Control Trial, Activity Sensors, Motor Learning, Retention, Wearable Sensors, Celsentri
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaravirocDrug
Also called Celsentri
Half of the participants will take maraviroc for a period of 8 weeks.
Exercise ProgramBehavioural
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 physiotherapy \& occupational therapy) 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.
PlaceboOther
Also called "Sugar" Pill
Half of the participants will take a placebo for a period of 8 weeks.
Activity SensorDevice
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.
Motor LearningBehavioural
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 72 hours of the initial assessment (initial test and retention test).
| Study group | Role | What they receive |
|---|---|---|
| Maraviroc (Celsentri) | Experimental | 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). Receives: Drug: Maraviroc; Behavioral: Exercise Program; Device: Activity Sensor; Behavioral: Motor Learning |
| Placebo | Placebo comparator | 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). Receives: Behavioral: Exercise Program; Other: Placebo; Device: Activity Sensor; Behavioral: Motor Learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (between 5 days and 8 weeks after stroke), after 4 weeks on drug/placebo, after 8 weeks on drug/placebo, and 6-months post-stroke
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.
Measured: Baseline (between 5 days and 8 weeks after stroke), after 4 weeks on drug/placebo, after 8 weeks on drug/placebo, and 6-months post-stroke
Secondary outcomes (2)
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).
Measured: Baseline (between 5 days and 8 weeks after stroke), after 4 weeks on drug/placebo, after 8 weeks on drug/placebo, and 6-months post-stroke
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.
Measured: Baseline (between 5 days and 8 weeks after stroke), after 4 weeks on drug/placebo, after 8 weeks on drug/placebo, and 6-months post-stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start15 Sep 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Sean Dukelow, MD PhD FRCPC, Principal investigator, University of CalgaryBruce Dobkin, MD, Study chair, University of California, Los Angeles, California, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789616
- Sponsor's protocol ID
- REB21-0258
- Acronym
- CAMAROS
- Status last verified
- Jul 2024
- First submitted
- 5 Mar 2021
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22044517Ben Assayag E, Shenhar-Tsarfaty S, Korczyn AD, Kliper E, Hallevi H, Shopin L, Auriel E, Giladi N, Mike A, Halevy A, Weiss A, Mirelman A, Bornstein NM, Hausdorff JM. Gait measures as predictors of poststroke cognitive function: evidence from the TABASCO study. Stroke. 2015 Apr;46(4):1077-83. doi: 10.1161/STROKEAHA.114.007346. Epub 2015 Feb 12.
PubMed 25677599Ben Assayag E, Tene O, Korczyn AD, Shopin L, Auriel E, Molad J, Hallevi H, Kirschbaum C, Bornstein NM, Shenhar-Tsarfaty S, Kliper E, Stalder T. High hair cortisol concentrations predict worse cognitive outcome after stroke: Results from the TABASCO prospective cohort study. Psychoneuroendocrinology. 2017 Aug;82:133-139. doi: 10.1016/j.psyneuen.2017.05.013. Epub 2017 May 18.
PubMed 28549269Dobkin BH. A Rehabilitation-Internet-of-Things in the Home to Augment Motor Skills and Exercise Training. Neurorehabil Neural Repair. 2017 Mar;31(3):217-227. doi: 10.1177/1545968316680490. Epub 2016 Nov 24.
PubMed 27885161Duncan 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.
PubMed 21612471Hiragami S, Inoue Y, Harada K. Minimal clinically important difference for the Fugl-Meyer assessment of the upper extremity in convalescent stroke patients with moderate to severe hemiparesis. J Phys Ther Sci. 2019 Nov;31(11):917-921. doi: 10.1589/jpts.31.917. Epub 2019 Nov 26.
PubMed 31871377Joy 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 30794775Lohse K, Bland MD, Lang CE. Quantifying Change During Outpatient Stroke Rehabilitation: A Retrospective Regression Analysis. Arch Phys Med Rehabil. 2016 Sep;97(9):1423-1430.e1. doi: 10.1016/j.apmr.2016.03.021. Epub 2016 Apr 22.
PubMed 27109329Zhou M, Greenhill S, Huang S, Silva TK, Sano Y, Wu S, Cai Y, Nagaoka Y, Sehgal M, Cai DJ, Lee YS, Fox K, Silva AJ. CCR5 is a suppressor for cortical plasticity and hippocampal learning and memory. Elife. 2016 Dec 20;5:e20985. doi: 10.7554/eLife.20985.
PubMed 27996938
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CAMAROS Trial: The Canadian Maraviroc Randomized Controlled Trial To Augment Rehabilitation Outcomes After Stroke
- ClinicalTrials.gov ID
- NCT04789616
- Acronym / sponsor ID
- CAMAROS / REB21-0258
- Conditions
- Stroke
- Keywords
- Rehabilitation, Exercise, Maraviroc, Randomized Control Trial, Activity Sensors, Motor Learning, Retention, Wearable Sensors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- 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
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Mar 2021 (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.
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 8 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 72 hours of each formal assessment (initial test and 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.
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 (Celsentri) | Experimental | Drug: Maraviroc, Behavioral: Exercise Program, Device: Activity Sensor, Behavioral: Motor LearningMaraviroc (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). |
| Placebo | Placebo comparator | Behavioral: Exercise Program, Other: Placebo, Device: Activity Sensor, Behavioral: Motor LearningAn 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Primary ischemic anterior circulation stroke
- Age ≥18 years
- At least 5 days after stroke but within 8 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
Key exclusion criteria (25 listed)
- 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
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: CelsentriHalf of the participants will take maraviroc for a period of 8 weeks. | Drug | Maraviroc (Celsentri) |
| Exercise ProgramAll 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 physiotherapy \& occupational therapy) 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. | Behavioural | Maraviroc (Celsentri), Placebo |
| PlaceboAlso: "Sugar" PillHalf of the participants will take a placebo for a period of 8 weeks. | Other | Placebo |
| Activity SensorParticipants 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. | Device | Maraviroc (Celsentri), Placebo |
| Motor LearningParticipants 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 72 hours of the initial assessment (initial test and retention test). | Behavioural | Maraviroc (Celsentri), Placebo |
Primary outcome
Change in Fugl-Meyer Upper Extremity Assessment Score
Time frame: Baseline (between 5 days and 8 weeks after stroke), after 4 weeks on drug/placebo, after 8 weeks on drug/placebo, and 6-months post-stroke
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
Time frame: Baseline (between 5 days and 8 weeks after stroke), after 4 weeks on drug/placebo, after 8 weeks on drug/placebo, and 6-months post-stroke
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.
2 secondary outcomes
Action Research Arm Test (ARAT)
Time frame: Baseline (between 5 days and 8 weeks after stroke), after 4 weeks on drug/placebo, after 8 weeks on drug/placebo, and 6-months post-stroke
6 Minute Walk Test
Time frame: Baseline (between 5 days and 8 weeks after stroke), after 4 weeks on drug/placebo, after 8 weeks on drug/placebo, and 6-months post-stroke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Background: PubMed 22044517Ben 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.
- Background: PubMed 25677599Ben Assayag E, Shenhar-Tsarfaty S, Korczyn AD, Kliper E, Hallevi H, Shopin L, Auriel E, Giladi N, Mike A, Halevy A, Weiss A, Mirelman A, Bornstein NM, Hausdorff JM. Gait measures as predictors of poststroke cognitive function: evidence from the TABASCO study. Stroke. 2015 Apr;46(4):1077-83. doi: 10.1161/STROKEAHA.114.007346. Epub 2015 Feb 12.
- Background: PubMed 28549269Ben Assayag E, Tene O, Korczyn AD, Shopin L, Auriel E, Molad J, Hallevi H, Kirschbaum C, Bornstein NM, Shenhar-Tsarfaty S, Kliper E, Stalder T. High hair cortisol concentrations predict worse cognitive outcome after stroke: Results from the TABASCO prospective cohort study. Psychoneuroendocrinology. 2017 Aug;82:133-139. doi: 10.1016/j.psyneuen.2017.05.013. Epub 2017 May 18.
- Background: PubMed 27885161Dobkin BH. A Rehabilitation-Internet-of-Things in the Home to Augment Motor Skills and Exercise Training. Neurorehabil Neural Repair. 2017 Mar;31(3):217-227. doi: 10.1177/1545968316680490. Epub 2016 Nov 24.
- Background: PubMed 21612471Duncan 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.
- Background: PubMed 31871377Hiragami S, Inoue Y, Harada K. Minimal clinically important difference for the Fugl-Meyer assessment of the upper extremity in convalescent stroke patients with moderate to severe hemiparesis. J Phys Ther Sci. 2019 Nov;31(11):917-921. doi: 10.1589/jpts.31.917. Epub 2019 Nov 26.
- 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 27109329Lohse K, Bland MD, Lang CE. Quantifying Change During Outpatient Stroke Rehabilitation: A Retrospective Regression Analysis. Arch Phys Med Rehabil. 2016 Sep;97(9):1423-1430.e1. doi: 10.1016/j.apmr.2016.03.021. Epub 2016 Apr 22.
- Background: PubMed 27996938Zhou M, Greenhill S, Huang S, Silva TK, Sano Y, Wu S, Cai Y, Nagaoka Y, Sehgal M, Cai DJ, Lee YS, Fox K, Silva AJ. CCR5 is a suppressor for cortical plasticity and hippocampal learning and memory. Elife. 2016 Dec 20;5:e20985. doi: 10.7554/eLife.20985.
- Product Monograph for Celsentri (Maraviroc)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sean Dukelow, MD PhD FRCPC principal investigator
University of Calgary
Bruce Dobkin, MD study chair
University of California, Los Angeles, California, USA
6 sites 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, Exercise Program and Activity Sensor in people with Stroke, run by University of Calgary at 6 sites in Canada.
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 16 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandra McKinnon (403-944-4050, alexandra.mckinnon@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fugl-Meyer Upper Extremity Assessment Score (time frame: Baseline (between 5 days and 8 weeks after stroke), after 4 weeks on drug/placebo, after 8 weeks on drug/placebo, and 6-months post-stroke). The study lists 2 primary outcomes in all. 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 NCT04789616, which also lists 9 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 9 Jul 2024.