The Mellen Center for MS Treatment and Research conducts clinical trials with the goal of advancing the development of new treatments and diagnostic tools for multiple sclerosis.
What is a clinical trial?
Clinical trials are the cornerstone of the drug and device development process. They are formal studies to determine if a new drug, device, or therapy is both SAFE and EFFECTIVE.
All new drugs and devices must go through several stages of testing before they are approved by the FDA to treat patients. There are four general types of clinical trials, corresponding to the different stages in the development of a new therapy:
- Phase I: The initial trial of a drug or device in humans. Phase I trials provide preliminary evidence whether a drug or device is SAFE for use in humans. These trials may test a range of doses of a drug. These may involve healthy controls or individuals with a specific disease. Usually involve 20-80 individuals.
- Phase 2: Phase 2 trials provide preliminary evidence whether a drug or device has a beneficial biological action for the treatment of a disease. They also provide additional information on the safety. Usually involve 100-300 individuals.
- Phase 3: Phase 3 trials are much larger studies which give the FDA more solid information on both the SAFETY and BENEFITS of a drug or device. These studies collect information about side effects and sometimes compare the new drug or device to those already on the market. Usually involve 1000-3000 individuals.
- Phase 4: Post-marketing studies performed after a drug or device is already FDA approved. These give additional information on safety and effectiveness in a much broader range and larger number of people. These studies help to determine if there are any problems associated with long-term use. Involve 1000+ individuals.
Why should I consider participation?
The success of finding new treatments and therapies relies on there being enough people willing to participate in clinical trials. Participants are followed very closely throughout their involvement in a trial. All assessments and interventions are performed according to the protocol for the specific trial. Many people participate to gain access to the newest experimental treatment options prior to FDA approval. Finally, some individuals participate to help other people who have their disease in the future.
How do I find out if I am eligible for participation in a clinical trial?
Clinical trials usually have very specific criteria for participation, and only individuals who meet those criteria may enroll. To determine if you are eligible, speak with your Mellen Center clinical team or the clinical trial research contact, listed for each actively enrolling clinical trial.
How do I find more information about clinical trials?
For additional information on clinical trials in general, see the U.S. National Institutes of Health site:
For a comprehensive list of clinical trials in the United States, please refer to clinicaltrials.gov:
Non Interventional Studies at the Mellen Center
Non-interventional research involves the study of one or more characteristics of a disease without directly administering a treatment or intervention. Many non interventional studies examine the natural process of disease. Others test the effectiveness of medications patients have already started. The Mellen Center conducts a large amount of non interventional studies to understand MS better, develop new measurement tools for MS, gather ideas about possible new medications, and test the effectiveness of medications in clinical practice. A large portion of non interventional studies includes the use of new technology or laboratory tests to improve our understanding of the disease.
Innovative Clinical Measures
Research at the Mellen Center is focused on developing sensitive tools to measure the loss of function which is sometimes associated with MS. In the past neurologist relied on semi-quantitative measures based on the physical examination; however these measures are not very sensitive and differ significantly from one rater to the other. The Mellen Center is studying novel technology based assessments of neurological function. These include dynamic gait analysis and testing of neurological function using measurements obtained from accelerometers in common devices such as I-Pads. Testing of memory, concentration and attention is also being studies using technologies that may, in the future, allow patients to be monitored from the comfort of their own home and conducting their regular activities. The Mellen Center is also investigating patient self reported measures of function and quality of life, as these measures have received little attention in the past and may be sensitive to change when following MS over time.
Magnetic resonance imaging (MRI) is a valuable tool for diagnosing and following MS patients. MRI can also be used to better understand the disease process and helps identify MS therapies in early stages of development. The Mellen Center has a dedicated Neuro Imaging Laboratory with MRI units housed in the Mellen Center building. A high field (7 Tesla) MRI machine was recently acquired, which is the first of its kind in Northeast Ohio and is among only a handful of such units across the entire country. The Mellen Center has a team of technicians, engineers and physicists who use advanced MRI to answer questions about the natural history of MS, how MS lesions develop, how MS medications work, and how to detect MS in early stages. MRI research may occur in the context of an interventional study (i.e. clinical trials). Techniques commonly used at the Mellen Center include diffusion tensor imaging or DTI, which analyzes the movement of water in brain tissue. Functional MRI (fMRI) combines anatomical images with measures of brain metabolism and function which allows investigators to understand how activation patterns in the brains of MS patients differ from normal individuals. Sensitive measures of atrophy have also been developed that allow researchers to measure how the thickness of the cortex changes over time and how this may relate to cognitive symptoms and disability.
Optical Coherence Tomography
Vision is commonly affected in MS and is most frequently caused by inflammation affecting the optic nerve. A novel technique called Optical Coherence Tomography (OCT) allows high resolution pictures to be taken of the retina of the eye. This allows for measurement of the nerve fiber layers in a rapid and highly reproducible manner. The Mellen Center has a spectral domain OCT until, which can capture data from patients in several minutes and may provide a window into disease processes in the brain. Research has focused on using the eye as a model system for testing of therapeutic agents in multiple sclerosis, and also as a sensitive biomarker of MS disease activity.
The identification of a laboratory marker to help diagnose, prognosticate, or predict response to treatment in MS has been elusive to date. The Mellen Center is looking at several blood and cerebrospinal fluid markers that may prove useful in the clinical care of MS patients in the future. One such marker is Vitamin D, which has received significant attention as it appears to be low in MS patient and levels tend to correlate with disease activity. Studies that incorporate imaging, OCT and blood markers, such as Vitamin D, will be useful in determining the utility of these markers and possible interventions.
Basic Science Research
Research in the laboratory aims to understand the biological mechanism through which MS occurs and mechanisms which underlie the evolution of the disease over time. Basic science research commonly uses tissue from MS patients and other experimental models. Basic science research at the Mellen Center is conducted by scientists at the Lerner Research Institute who also see MS patients and understand the unmet needs of MS patients. Basic science is the most direct line for the discovery of new therapies for MS. Research at the Mellen Center has focused on the neurodegenerative aspects, including potential mitochondrial injury, and the inflammatory processes of the disease. The use of high resolution serial section 3D microscopy allows researchers to evaluate changes occurring at the ultra-structural level. Models simulating the blood brain barrier have also been developed which may aid in the identification of novel therapeutic molecules. The Mellen Center supports an active brain donation program which allows our scientists to directly examine the brain and the changes seen in MS.
Meet the Research and Clinical Trials Team
Additional Clinical Trial Team Members:
- Charlene Belsole, CCRP
- Dee Ivancic, CCRP
- Danielle Kemeny, BA
- Genna Losinski, BS
- John Mays, CCRP
- Bernadett Mamone, PhD
- Sarah Planchon Pope, PhD, CCRP
- Sneha Natarajan, PhD, CCRP
- Tammy Skaramagas, CCRP
- Susan Sharp, BSN, RN
- Maria Stadtler, CCRP
- Darlene Stough, RN, MSCN, CCRP
Back row - Left to Right: Dee Ivancic, Darlene Stough, Susan Sharp, John Mays, Jennifer Resto, Genna Losinski, Tammy Skaramagas
Front row - Left to Right: Sarah Planchon Pope, Char Belsole, Sneha Natarajan, Danielle Kemeny, Bernadett Mamone