Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04789616
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2021-03-05
Brief Title:
The Canadian Maraviroc Randomized Controlled Trial To Augment Rehabilitation Outcomes After Stroke
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
The CAMAROS Trial The Canadian Maraviroc Randomized Controlled Trial To Augment Rehabilitation Outcomes After Stroke
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAMAROS
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 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 drugplacebo after 8 weeks of taking the drugplacebo 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
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 drugplacebo after 8 weeks of taking the drugplacebo 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None