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NCT03172026 · ClinicalTrials.gov registry record · Phase 2
Maraviroc to Augment Rehabilitation Outcomes After Stroke
A Phase 2 study, sponsored by University of California, Los Angeles.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT03172026 is a Phase 2 study that was terminated before completion, run by University of California, Los Angeles. The registered enrollment target is 2 participants.
The verdict
NCT03172026, a Phase 2 study, was terminated before completion, sponsored by University of California, Los Angeles.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study 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.
Interventions
- DRUG Maraviroc 300 mg
- BEHAVIORAL Rehabilitation therapy
- DRUG Placebo 300 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2019-08-01 |
| Est. Completion | 2020-10-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03172026
The ClinicalTrials.gov registry entry for NCT03172026 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Maraviroc 300 mg is the first listed.
NCT03172026 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03172026 about?
NCT03172026 is a clinical study titled "Maraviroc to Augment Rehabilitation Outcomes After Stroke". 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, howe...
What is the current status of trial NCT03172026?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2019-08-01. Estimated completion is 2020-10-01.
What interventions are being tested in trial NCT03172026?
The interventions under investigation include: Maraviroc 300 mg (DRUG), Rehabilitation therapy (BEHAVIORAL), Placebo 300 mg (DRUG).
Who is sponsoring clinical trial NCT03172026?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
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