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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., 410-328-1885 or Elizabeth Wheeler, R.N., 410-328-7602 at the MS Center.
1. The ITN trial is a trial using an investigational medication named Abatacept. Abatacept is a medication that interacts with your immune system and makes the cells less active. Slowing the action of these cells appears to lower your immune system?s ability to attack healthy tissues in your brain. A total of 123 participants will be randomly assigned to either abatacept or placebo. This is a 24 week trial with an extension period of 24 weeks where the participants will switch to the other arm of treatment that they did not have in the original 24 weeks.
Investigator: Walter Royal, MD
Eligibility: This trial is designed for people 18-65 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 have injectable medications to treat their MS for the 4 weeks prior to the trial.
2. This study is sponsored by Biogen Idec and is looking at the effectiveness of natalizumab (Tysabri®) in patients with secondary progressive multiple sclerosis. Natalizumab is approved as a treatment for multiple sclerosis (MS) in over 50 countries, and also for Crohn?s disease (CD) in the United States. The main purpose of this research study is to see if natalizumab is effective in slowing the progression of disability independently of relapse in SPMS. This is a 27 month study where patients will receive either natalizumab or placebo by IV infusion monthly.
Investigator: Robert Shin, MD
Eligibility: Patients must have secondary progressive MS for at least 2 years and be 18 to 58 years old. They must have documented disease progression over the last year, able to ambulate with at least a walker, and not currently be on any of the injectable therapies for MS within the past 4 weeks.
3. This new arbaclofen trial is for patients with multiple sclerosis who are experiencing spasticity. Arbaclofen is being compared to baclofen, a currently approved anti-spasticity medicine, and to placebo, an inactive substance, to see if it is superior to the currently available spasticity medications. During the study, your current medications for spasticity will need to be discontinued. There will be approximately 10 visits over a 21-23 week period. They are allowed to be on current injectable therapies for the treatment of their MS.
Principal Investigator: Christopher Bever, MD
Eligibility: 18-65 years of age, diagnosis of multiple sclerosis with no recent history of relapse, and no history of seizures
4. 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 Copaxone. 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, MD
Eligibility: This trial is designed for people 18-65 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 be on any of the injectable medicines routinely prescribed for the treatment of MS during the trial.
Currently recruiting clinical trial opportunities are constantly changing. Please keep in touch if you are interested in trials!
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