Opportunities are available for individuals with Multiple Sclerosis to participate in several new clinical trials at the University of Maryland Center for Multiple Sclerosis. These studies are either currently enrolling or will be enrolling shortly. The studies vary in design, duration, criteria for eligibility, number of MRI scans, and other details. The following is a very brief summary of each study. You may obtain further information by calling Kerry Naunton, R.N., 410-328-1155 or Elizabeth Wheeler, R.N., 410-328-7602 at the MS Center.
The CombiRx trial is a trial comparing the use of Avonex alone, Copaxone alone or Avonex and Copaxone in combination. Participants will be blinded, meaning that they will not know which drugs they will be on. Both Avonex and Copaxone are currently marketed drugs for the treatment of relapsing remitting MS. This is a 3 year trial for which interested participants must have never been on any other injectable therapies for the treatment of their MS.
Investigator: Kenneth P. Johnson, M.D.
Eligibility: Participants must be between the ages of 18-60 years old, diagnosed with relapsing remitting MS, and had at least 2 exacerbations in the prior 2 years.
The MS Genetic Susceptibility Project is a study with its primary goal to identify the underlying genetic causes of multiple sclerosis. Subjects will be asked to come to the clinic for one visit, which will include a blood draw as well as an exam by the doctor. This study is looking for not only patients with MS, but also for family members of people with MS.
Investigator: Walter Royal, M.D.
Eligibility: Participants must have either been diagnosed with MS or be a family member of someone with MS and be willing to have blood drawn.
The Novartis trial is a study of an oral medication named fingolimod. Fingolimod is a once daily medication that acts on certain types of white blood cells called lymphocytes. It makes their cells move away from sites of inflammation and redirects them towards lymph nodes and other places in the body where they rest. The study is 24 months long and has 3 treatment groups: high-dose fingolimod, low-dose fingolimod and placebo. It is a blinded study, which means that neither your study doctor nor you will know which dosing group you are in.
Investigator: Robert Shin, M.D.
Eligibility: This trial is designed for people 18-55 years of age who have relapsing remitting multiple sclerosis and who have had at least 1 relapse in the past year. Subjects who are interested must not currently be on any of the injectable medicines routinely prescribed for the treatment of MS.
The Maestro-03 study is a study that evaluates the use of MBP8298 in patients that have secondary progressive multiple sclerosis. MBP8298 may delay the worsening of disability in MS. It is a synthetic or man-made protein that has the same amino acid sequence of a larger protein called myelin basic protein (MBP). MBP is found in myelin in the brain, which is what is destroyed in people with MS. It is a 24-month trial where the study drug is given intravenously every 6 months.
Investigator: Horea Rus, M.D.
Eligibility: Patients must be 18-65 years old with secondary progressive MS and not currently on injectable treatments for their MS.
The Genzyme Care-MS II trial is a study of an IV medication called Campath. Patients who are interested in this trial must have relapsing-remitting multiple sclerosis with an onset of MS symptoms within the past 5 years. Campath is a drug that is given once yearly over a course of 5 days. In this trial patients will be assigned to one of 3 treatment groups: high-dose Campath, low-dose Campath, or Rebif (the currently FDA approved dose of injectable medication) as the control arm. In phase II trials, Campath was found to have a 75% reduction in relapse rate. This trial is a 3-year trial.
Investigator: Walter Royal, M.D.
Eligibility: Subjects must be 18 to 50 years old, able to walk without aides, have had 2 relapses in the prior 2 years and 1 relapse in the prior 1 year.
The Biogen 109MS302 trial is a trial to evaluate the use of an oral drug, BG00012, in patients that have relapsing remitting multiple sclerosis. In a phase 2 trial BG00012 the drug was shown to significantly reduce gadolinium enhancing lesions on MRI's. The study is a 2-year study where patients will be randomized into one of four treatment groups. Two of the groups will receive BG00012, one group will receive placebo or nonactive pills and the fourth group will receive the currently FDA approved dose of Copaxone as a control group.
Investigator: Robert Shin, M.D.
Eligibility: Patients must be 18-55 years old, with relapsing remitting MS who have had 1 relapse within the past year. They must not currently be on any injectable therapies and have never been on Copaxone before.
The Teva MSLAQ-302 trial is a trial to evaluate the use of an oral drug, laquinimod, in patients that have relapsing remitting multiple sclerosis. The study is a 2-year study where patients will be randomized into one of 3 treatment groups. One of the groups will receive laquinimod, one group will receive placebo or nonactive pills and the third group will receive the currently FDA approved dose of Avonex as a control group.
Investigator: Walter Royal, M.D.
Eligibility: Patients must be 18-55 years old, with relapsing remitting MS, be able to walk without any assistance and have had 1 relapse in the previous year or 2 in the previous 2 years. They must not currently be on any injectable therapies.
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