Maraviroc to Augment Rehabilitation Outcomes After Stroke

• Status: Terminated
• Trial end date: 2020-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Collaborator: Burke Rehabilitation Hospital
• Treatments: Maraviroc

Criteria

Inclusion Criteria:

• Transfer to inpatient rehabilitation within 4 weeks of stroke onset

• Single ischemic or subcortical hemorrhagic infarct;

• At the time of randomization, hemiparesis with 4/5 or less strength at the hip and ankle flexors and extensors

• Functional Independence Measure (FIM) score for ambulation ≥3 to walk at least 10 steps;

• Caregiver available for at least two hours a day for practice and transportation when needed;

• Adequate language skills to read and understand the Informed Consent and retain information during daily therapies.

Exclusion Criteria:

• Prior stroke with persisting motor impairment or disability;

• Limited resources or illness that will not enable a return to living outside of a facility;

• Any medical condition that had limited daily physical activity to walking no more than 2 blocks outdoors prior to the stroke (e.g., claudication, congestive heart failure or lower extremity pain);

• History of dementia or Mini Mental State Examination score <24;

• History of hepatitis or elevated hepatic transaminases or bilirubin;

• History of renal insufficiency or serum creatinine over 1.6;

• Cancer or other chronic illness that makes 3-year survival unlikely or will detract from the ability to carry out exercise and skills practice.