Participants will take Maraviroc 300 mg daily for 60 days, plus receive rehabilitation therapy as prescribed by the doctors and via telerehabilitation.

Participants will take placebo 300 mg daily for 60 days, plus receive rehabilitation therapy as prescribed by the doctors and via telerehabilitation.

Stroke

FDA approved chemokine receptor (CCR5) inhibitor. Maraviroc will be started within two weeks of discharge from inpatient rehabilitation, which most often will occur from 4-6 weeks after stroke onset.

Maraviroc 300 mg

All participants will have routine outpatient or home health physical and occupational therapy after inpatient discharge as prescribed by their physicians.
Each group will be contacted weekly by phone to help maintain interest in the trial, count the number of usual care physical and occupational therapy completed, assure use of the assigned medication, ask about possible adverse reactions, and to encourage them to be active. The coordinator will obtain this information and provide the feedback using a standard script and checklist. A unique aspect of this trial is a telerehabilitation component that aims to give feedback to all participants to practice with the affected arm and walk daily.

Rehabilitation therapy

Matched placebo will be started within two weeks of discharge from inpatient rehabilitation, which most often will occur from 4-6 weeks after stroke onset.

Placebo 300 mg

California Rehabilitation Institute

Yale University

Burke Neurological Research Institute

Maraviroc to Augment Rehabilitation Outcomes After Stroke

Timed walking speed over 10 meters. The evaluable sample size of 30 in each group will have 80% power to detect a difference in means of -0.206 (m/s), the difference between an assumed usual care walking speed of 0.51 (SD=0.28) and an assumed intervention group mean walking speed of 0.716. This assumes a common standard deviation in the two groups and a two group t-test with a 0.05 two-sided significance level. The estimates for the mean and standard deviation for walking speed come from the LEAPS RCT (Duncan, N Engl J Med, 2011). The t-test used for the power calculation is a simplification of the mixed effects analysis plan for the primary endpoints.

Assessment of upper extremity function. Our sample size of 30 for each group is based on a statistical power of 80% with an alpha of 5% for detecting a meaningful difference of 6 points, i.e., a 10% change, which has been suggested by several completed trials. In a stroke trial, the standard deviation was 8 points measured at 2 weeks post stroke.

Assessment of arm and leg impairment after stroke

Self-report questionnaire on quality of life post-stroke

Distance walked in a 6 minute time period

Self-report questionnaire related to exercise enjoyment

Self-report questionnaire related to confidence in increasing activity and maintaining exercise routines

Bruce H. Dobkin

Principal Investigator

University of California, Los Angeles

We plan a parallel group, randomized controlled pilot trial at two sites, UCLA and Burke Rehabilitation Center in White Plains, NY, to gather enough entries in a shorter time and to better generalize the results of this phase II/III pilot trial.

flecainide x 6 months, then crossover to sotalol x 6 months

sotalol x 6 months, then crossover to flecainide x 6 months

Atrial Fibrillation

flecainide up to 150mg twice daily for the control of atrial fibrillation

Flecainide

sotalol up to 120mg twice daily for the control of atrial fibrillation

Sotalol

Jesse Brown VA Medical Center

Rush University Medical Center

University of Illinois at Chicago

Advocate Christ Medical Center

Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation

A Prospective, Multi-Center, Randomized, Open Label Trial to Determine if a Common Atrial Fibrillation Risk Locus Modulates Differential Response to Antiarrhythmic Drugs

Subjects will be monitored with the Medtronic Reveal LINQ Insertable Cardiac Monitor (ICM) system to assess AF burden. The device will be programmed to optimize the memory for storing AF episode..

Quality of life assessment: Patients will be asked to fill out the AFEQT quality of life questionnaire baseline (study randomization), two, four, six, eight, ten, and 12 months (completion of the study). The questionnaire at the end of the 6rd month will be administered just prior to stopping the first study drug. The validated questionnaire is comprised of 20 questions about AF symptoms with answers given on a Likert scale. The questionnaire will be provided to the patients in paper format either in person or by mail, as applicable. A follow-up phone call will be made to each patient to ensure that the questionnaire is completed and returned.

Dawood Darbar, MD

Professor of Medicine

Medtronic

Subjects will receive two 5mg tablets of Montelukast/day.

Subjects will receive one 5mg tablet of montelukast and 1 placebo tablet per day.

Subjects will receive two placebo tablets per day.

Eosinophilic Esophagitis

Those in Montelukast 10mg/day group will receive two 5mg tablets of Montelukast.

Montelukast

Those in the placebo group will receive 2 placebo tablets per day. Those in the Montelukast 5mg/day will receive 1 placebo tablet per day.

placebo

Subject will receive one 5mg tablet of Montelukast and one placebo tablet per day.

5 mg Montelukast

Children's Mercy Hospitals and Clinics

A Trial of Montelukast for Maintenance Therapy of Eosinophilic Esophagitis in Children

Eosinophils/hpf in the esophagus will be measured after 12 weeks of therapy.

eosinophilia/edema

Maraviroc to Augment Rehabilitation Outcomes After Stroke

Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation

A Trial of Montelukast for Maintenance Therapy of Eosinophilic Esophagitis in Children

Plasma and Abscess Fluid Pharmacokinetics of Cefpirome and Moxifloxacin After Single and Multiple Dose Administration

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