Clinical Trials

Scientists have made considerable progress in understanding the nature of multiple sclerosis, leading to the development of several drug therapies since the 1990s. Although these treatments represent major therapeutic advances, they provide only partial benefit to MS patients, and they can be complicated to administer.

Still, there is reason for great optimism. Scientific advances have provided a rationale for the development of numerous additional therapeutic agents that are now in clinical trials. Their success have attracted the interest of biotech and pharmaceutical companies that are now actively performing and sponsoring research aimed at finding new and effective therapies.

With this in mind, the Corinne Goldsmith Dickinson Center for Multiple Sclerosis has established a leading-edge clinical trials program with a planned state-of-the-art database management system. The clinical trials unit tests experimental agents and allows patients access to groundbreaking therapies not yet widely available. For example, the Center has coordinated a national, multi-center combination therapy trial to determine whether a promising new drug combination is indeed safe and effective for multiple sclerosis.

Enrollment

We are actively recruiting patients for a variety of research studies ranging from clinical trials to registries:

  • TOPIC (PI: Fred Lublin, MD). The purpose of this research study is to demonstrate the effect of the investigational drug teriflunomide (14 mg/day and 7 mg/day) compared to placebo on reducing the conversion of patients who have their first clinical episode consistent with multiple sclerosis to clinically definite multiple sclerosis. Participation in this trial may last approximately two years and will entail multiple assessments of general health, including but not limited to physical exam, blood pressure, blood samples, as well as neurological status, including but not limited to MRI and neurological examinations. If your onset of MS symptoms was in the last 60 days and you are interested in learning more about this trial, please call Christine Hannigan at 212-241-7858. GCO# 08-0364, MSSM approved through 6/9/2012.
  • Exacerbation Recovery Study (PI: Stephen Krieger, MD). Patients who experience an exacerbation of an MS symptom, also known as an MS “attack” or “relapse,” may qualify for enrollment in this research study. This is a standard-of-care observational study, which means we follow patients who are receiving treatment for their MS exacerbation with three to five days of IV steroids, according to our standard practice. The study entails having a comprehensive neurological examination on each day of steroid treatment at the MS Center, and one follow-up examination one month later. Participation will last approximately one month. With this study we intend to answer the questions “How long will the steroids take to work?” and “Are these new symptoms likely to completely recover?” If you believe you are experiencing an exacerbation and are interested in participating in the study, please call Colleen Farrell at 212-241-3048. GCO# 04-0174, MSSM approved through 3/17/2012.
  • Screening for Depression in Patients with Multiple Sclerosis (PI: Aliza Ben-Zacharia, DrNP ANP-BC). Depression is a common occurrence among patients with multiple sclerosis, and proper screening is very important in the diagnosis and management of depression. The purpose of this research study is to compare the effectiveness of two screening tools that are used to assess depression. The study will also assess the relationship between depression and disability (level of function) and the relationship between number of relapses and overall depression. Participation entails completing a questionnaire and answering questions about depression and how you feel during a routine visit lasting approximately 45 minutes. If you are diagnosed with multiple sclerosis, you are not taking an antidepressant, and you are 18 years of age or older, you may be eligible to participate. If you are interested in participating, contact Aliza Ben-Zacharia at 212-241-0538. GCO# 06-0951, MSSM approved through 10/23/2011.
  • Patient Registry of the NY State MS Consortium (PI: Fred Lublin, MD). The New York State Multiple Sclerosis Consortium (NYSMSC) is a partnership of 17 multiple sclerosis centers in New York State. The purpose of the study is to gain a better understanding of multiple sclerosis in New York State in terms of the number of people who have it, patient demographics (e.g., age, sex, and education), type of multiple sclerosis, and treatment medication schedule. The study consists of an initial visit and standard clinical follow-up visits that occur once a year over approximately 10 years. The study visit consists of filling out a questionnaire and completing the Multiple Sclerosis Functional Composite Test (MSFC), which takes approximately one hour. The MSFC consists of three evaluations: a timed 25-foot walk, which determines walking ability; a nine-hole peg test, which is a hand coordination test that requires putting pegs into nine holes; and the Paced Auditory Serial Addition Task, which tests mental function. If you are diagnosed with multiple sclerosis and are interested in participating, contact Colleen Farrell at 212-241-3048. GCO# 05-1167, MSSM approved through 1/31/2012.
  • Biobank (PI: Erwin Böttinger, MD). Biobank is a database of blood samples and health information to be used in current and future research projects. Using genetic information obtained from blood samples along with health information, scientists can gain a better understanding of the factors that cause disease. By volunteering, which requires a one-time blood draw and completion of a family history questionnaire, you will be contributing to research that may lead to new preventive strategies or treatments for future generations. Heart disease, cancer, asthma diabetes, and Alzheimer's disease are just a few of the conditions Biobank may help scientists understand. If you are a patient of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis and are interested in learning more about this project, call Christine Hannigan at 212-241-7858. GCO# 07-0529 IRB Approved through 7/10/2012.

In addition to the clinical trials above, the Corinne Goldsmith Dickinson Center for Multiple Sclerosis has ongoing clinical trials using Fingolimod/Gilenia for secondary progressive MS (Novartis), Campath/Alemtuzumab for relapsing remitting MS (Genzyme), stem cells for relapsing or secondary progressive MS (Celgene), Teriflunomide for clinically isolated syndrome (Sanofi-Adventis), Daclizumab for relapsing remitting MS (Biogen), BG12 for relapsing remitting MS (Biogen), and a study looking at the JCV virus for patients on Tysabri or considering Tysabri (Biogen).

Faculty and nurse practitioners at the Center are also studying MS patients’ emergency medical needs as part of the Mount Sinai Resource Utilization in MS (RESUMS) Project, patient compliance and adherence to the self-injected disease-modifying therapies, the long-term prognosis of MS patients, and MS-variants such as Tumofactive MS and Devic’s disease.


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