Maraviroc to Augment Rehabilitation Outcomes After Stroke
Status:
Terminated
Trial end date:
2020-10-01
Target enrollment:
Participant gender:
Summary
After stroke, the combination of progressive skills practice in an adequate dose, exercise
for fitness, and reduced sedentary time will augment motor and cognitive outcomes.
Sensorimotor and cognitive improvements after stroke often reach a general plateau by
approximately 12 weeks after onset, however. 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, a CCR5 antagonist, may
augment skills learning during rehabilitation training, especially during the first three
months after onset, by affecting CREB and synaptic plasticity.
The investigators will carry out a randomized controlled trial of Maraviroc in patients with
disabilities severe enough to have required inpatient stroke rehabilitation and, based on our
preclinical data, who can start the drug intervention within 6 weeks of stroke onset. The
investigators will compare usual post-stroke care plus placebo versus Maraviroc given for 8
weeks in 60 participants. However, to try to maximize the amount of practice that is most
relevant to the primary outcome measurements and determine whether or not Maraviroc can
enhance the effects of training, as hypothesized, all participants will be tele-monitored by
mobile health devices and will receive weekly telephonic encouragement, based on device data,
to walk, reduce sedentary time, and reach and grasp in the home in between usual care
therapies. Compliance, serial motor changes over time, and self-management skills in making
use of the telerehabilitation devices will be a nested substudy of feasibility of remote
monitoring and feedback.