A Phase 2 interventional study of Maraviroc and Exercise Program in Stroke, sponsored by University of Calgary. Recruiting at 6 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-09.
Sponsored by University of Calgary · Phase 2, Interventional, and Treatment
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.
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.
7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's planned enrollment of 120 is above the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →University of Calgary is the lead sponsor of 686 studies on the registry; 189 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
At least one of the following:
Subgroup Stratification Criteria
For Upper Extremity Group:
For Lower Extremity Group:
Exclusion Criteria:
Currently taking any of the following anticonvulsant medications:
Currently taking any of the following antifungal and/or antibacterial medications:
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).
Drug: Maraviroc · Behavioral: Exercise Program · Device: Activity Sensor · Behavioral: Motor Learning
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).
Behavioral: Exercise Program · Other: Placebo · Device: Activity Sensor · Behavioral: Motor Learning
Half of the participants will take maraviroc for a period of 8 weeks.
Also known as: Celsentri
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.
Half of the participants will take a placebo for a period of 8 weeks.
Also known as: "Sugar" Pill
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.
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).
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.
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
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.
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
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).
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
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 8 weeks after stroke), after 4 weeks on drug/placebo, after 8 weeks on drug/placebo, and 6-months post-stroke
Fugl-Meyer Lower Extremity Assessment Score
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 8 weeks after stroke), after 4 weeks on drug/placebo, after 8 weeks on drug/placebo, and 6-months post-stroke
Patient Health Questionnaire 9 (PHQ-9)
A 9-question measurement used to screen for the presence and severity of depression.
Time frame: Baseline (between 5 days and 8 weeks after stroke), after 8 weeks on drug/placebo, and 6-months post-stroke
Stroke Aphasia Depression Questionnaire (SADQ)
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 8 weeks after stroke), after 8 weeks on drug/placebo, and 6-months post-stroke, 8-week assessment, and 6-month assessment
European Quality of Life Across 5 Domains (EQ-5D)
A self-completion questionnaire used to assess health-related quality of life.
Time frame: Baseline (between 5 days and 8 weeks after stroke), after 8 weeks on drug/placebo, and 6-months post-stroke
Stroke Impact Scale (SIS)
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 8 weeks after stroke), after 8 weeks on drug/placebo, and 6-months post-stroke
National Institutes of Health Stroke Scale (NIHSS)
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 8 weeks after stroke) and 6-months post-stroke
Montreal Cognitive Assessment (MoCA)
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 8 weeks after stroke) and 6-months post-stroke
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Calgary