UCSF Multiple Sclerosis CenterPatients who are evaluated at the Center are welcome to participate in clinical trials of experimental therapies or other studies that are designed to help us understand various aspects of the cause and natural history of MS. As of April 2002, we are conducting the following experimental studies. Some of these studies may be completed when you are seen at the Center, but other studies may be available. If you have an interest in research conducted at the Center, the neurologist or nurse who evaluates you will update this list at the time of your evaluation.
This is a research study about how natalizumab (TYSABRI®) affects immune reactions within and outside the central nervous system. The purpose of this study is to investigate the effects of natalizumab on the passage of white blood cells into the cerebrospinal fluid (CSF or spinal fluid).
We are also looking at the subsequent changes in immune and inflammatory responses in the spinal fluid and blood. By characterizing these effects of natalizumab in more detail, we hope to better understand how it acts to alleviate multiple sclerosis as well as predisposing to the unusual complication of progressive multifocal leukoencephalopathy (PML).
Each patient will undergo a total of 4 or 5 lumbar punctures (LPs). Subjects may undergo LP at either the screening (~day -7) or baseline visit, or at both visits in order to examine the stability of the measurements before treatment. The remaining 2-4 LPs will be selected by the investigator and patient from the post-infusion intervals on Days 1, 3, 7, or 21-28.
Additionally, subjects will return monthly thereafter (up to one year) for natalizumab infusions and will undergo follow-up LPs at months 6 (before natalizumab infusion) and 12 (mid-month before subsequent treatment outside of this protocol).
All patients will undergo phlebotomy at each LP interval as well as at months 3 and 9. Additionally, 5 people will take part in a blood-draw only component of the study once at least 5 people have enrolled in and completed one month of the main CSF study.
This study is open to enrollment. REQUEST INFORMATION.
The Department of Neurology is conducting a study to investigate the predicting factor of the initial demyelinating event severity, recovery, and time to subsequent onset of multiple sclerosis (MS). You may be eligible if you have MS or you have had clinically isolated syndrome (CIS)—a condition that sometimes precedes MS. CIS patients may have some of the following symptoms that are related to the central nervous system (the system that controls the nerves in our body):
Several arguments suggest that the initial presentation of CIS may predict the later progression of the disease. Although the predictable short-term course of CIS is often good, some patients recover poorly for these initial symptoms. This study will further our understanding about which aspects of the presentation of the illness have the greatest affect on the course of the disease.
The purpose of this study is to identify the demographic, clinical, and genetic factors that influence a person’s initial presentation of MS, the time it takes to recover, and the degree of recovery for that initial event and the time it takes to later develop ( or not develop) into MS. You will be asked to donate one sample of blood, approximately two tablespoons (25.5 milliliters), through a vein in my arm. This will take place either at your doctor’s office a laboratory or at your home. The actual blood draw will take about five minutes to perform.
This study is open to enrollment. REQUEST INFORMATION.
Dr. Emmanuelle Waubant of the UCSF Department of Neurology is running a study to see if riluzole is safe and effective in treating patients with early Multiple Sclerosis (MS) and Clinically Isolated Syndrome (CIS). The study will evaluate whether riluzole decreases the chance of progression from CIS to MS. You may participate in this research study if you had CIS no more than twelve months ago and if you are 18 through 55 years old.
The drug that we will be testing in this study is a pill called riluzole (Rilutek®). Riluzole was developed by Sanofi-Aventis for treatment of Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig’s disease, a fatal paralyzing disease with an unknown etiology. Riluzole slows neuronal death and as a result, delays the progression of ALS, which is influenced by the death of muscle-controlling nerve cells. Riluzole has been approved by the FDA for treatment of ALS, but it is currently not approved by the FDA for treating CIS or MS.
Approximately forty patients, which were seen at the UCSF MS Center within twelve months of CIS onset, will be enrolled in the study. Patients will be evaluated every month for the first 12 months and every three months thereafter for the total study duration of 24 months. Fifty percent of the patients will receive riluzole, and 50 percent of the patients will receive a placebo (an inactive sugar pill). All patients will start Avonex therapy at month three of the study. The study will be blinded, which means that neither you nor your doctor will know whether you are taking riluzole or a placebo.
This study is open to enrollment. REQUEST INFORMATION
This is being conducted by the UCSF Behavioral Medicine Research Center and is funded by the National Institutes of Health. This study will investigate the effects of stress on the development of new brain lesions, immune functioning, and clinical exacerbation. We also look at whether stress management programs can improve how people manage their stress and reduce the risk of new brain lesions and MS inflammation. If you (1) have a relapsing form of MS (relapsing remitting or secondary progressive, (2)experience exacerbations, (3) feel stressed much of the time, you may be eligible for this innovative new study.
If you take part in the study you would receive: 7 MRI scans over 18 months; 14 blood draws to look at your immune functioning; 14 tests of your stress hormones; and a stress management program. Your participation will help answer critical questions about the role of stress in MS and will help improve care in the future. Participants will also be paid up to $540.00 for completing the evaluations and MRIs over the 18 months of the study. Feedback about the results of the MRIs and testing can be given after the participant completes the study.
This study is open for enrollment. REQUEST INFORMATION
For more information call: (415) 379-5548 or (800) 923-1033
We are studying patients who have had some MS-like symptoms, but who may have not yet received a diagnosis of MS. We are monitoring these patients with MRI scans, blood draws, and neuropsychological testing. You must live within approximately 200 miles of the SF Bay Area to enroll in this study.
This study is closed to enrollment. REQUEST INFORMATION
Multiple Sclerosis is the most common acquired disease of the central nervous system in young adults. Genes, the fundamental hereditary units, are likely to play a role in determining who is at risk for developing MS, how the disease progresses, and how someone responds to therapy.
Recent technological advances together with a better understanding of the human genome are opening new and promising opportunities to unravel the genetic basis of MS. Our strategy for fueling gene discovery in MS relies on the meticulous scanning of the entire genome of patients, their relatives, and unrelated controls unaffected by MS.
Due to the complex nature of MS, a large number of participants are needed to accelerate discovery. Understanding the role of genes in MS could revolutionize the way this disease is diagnosed and treated.
This study is open to enrollment indefinitely. REQUEST INFORMATION
The research community has clarified the underlying biology of MS and shown great promise for developing improved therapy for it. Areas of research that hold promise in the near future include:
Principle of antibody inhibition by inert antibody fragments. The damaging part of antibodies is in red, and binds to macrophages and complement, which create the actual damage to the myelin. The protective fragment is in green. In the absence of the red fragment, protection is conferred because the green fragment still binds to the MOG protein on myelin but cannot bind the the macrophages and complement. These novel potential therapeutics have been cloned in the laboratory and are now being tried in models of MS.