UCSF Multiple Sclerosis Center
Open for Enrollment
- BG00012 Study
- Predicting Factors Study
- MBP8298 Study
- Fingolimod Study
- Riluzole Study
- Rituximab NMO Study
- Stress Study
- CIS Study
- Genetic Study
Closed for Enrollment
- Other Immune Studies
Resources
Patients 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.
Dr. Emmanuelle Waubant from the Department of Neurology at the University of California, San Francisco, is participating in a medical research study sponsored by Biogen IDEC. This project will look at the efficacy, safety, and tolerability of an investigational product (not approved by the FDA for treatment of MS) called BG00012 in reducing the number of relapses in patients with relapsing-remitting MS treated for up to two years. The purpose of this study is to find out whether or not treatment with BG00012 can decrease the number of MS relapses during a certain time period and has beneficial effects in people who have multiple sclerosis (MS).
Your study doctor will discuss your options to be treated with one of the approved MS therapies ( Avonex, Betaseron, Copaxon, Rebif) with you or to be enrolled into this study with experimental drug BG00012. There is a one in three chance of getting a placebo or sugar pill. Since receiving a placebo means that you will not receive any active treatment, your standard treatments will be delayed.
Once you have agreed to enter the study, you will be randomly assigned to either receive BG00012 or to receive a placebo in such a way that each treatment group has a similar mix of people.
You will have a two out of three chance of receiving BG00012 and a one out of three chance of receiving placebo. The placebo, which looks exactly like BG00012, contains no medicine, so it will not harm you or help you. There will be three treatment groups:
In all three groups, patients will take one capsule orally three times daily for one week. On Day 8, patients will increase their dosages to two capsules three times daily. Whether you take BG00012 or a placebo, you should always take these capsules with food. After a single, two-capsule dose of BG00012, the effects remain in your body for approximately eight hours.
Your dosing schedule may need to change if you experience certain abnormal laboratory results during the study and/or if you experience significant problems tolerating the treatment. Note: Do not make any changes to your dosing schedule without permission from the Study Doctor.
You may be allowed to stop treatment with BG00012 or placebo, if you meet one of the following requirements:
If you meet one of these requirements for ending treatment, you may choose to do one of the following:
With any option you choose, your blinded treatment assignment will remain blinded. In addition, you will be asked to sign another inform consent form to acknowledge that you understand what your treatment options are and that you understand the benefits and risks.
Since the safety of taking BD00012 in combination with other medications to treat MS has not been studied, other MS medications will not be allowed during the time that you are taking this study medication—with the exception of corticosteroids that can be used for treatment of multiple sclerosis relapses.
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. Bruce Cree MD, PhD and his colleagues from the Department of Neurology at the University of California, San Francisco, are participating in a medical research study sponsored by BioMS Technology Corporation (Canada). The purpose of this study is to evaluate the safety and effectiveness of 500 mg MBP8298 given intravenously every six months for a period of 18 months when compared to a placebo (a solution that looks like the study drug, but contains no active medication). Approximately 510 patients at approximately 50-75 study centers in the United States will take part in this study.
At the UCSF MS Center, we expect that approximately 15 patients will be eligible to participate in the study. This is a 37 month, randomized, double blind, placebo-controlled, parallel-group trial in Secondary Progressive Multiple Sclerosis (SPMS) patients, comparing the Time to Progression as measured by Expanded Disability Status Scale (EDSS).
You will be randomly assigned by chance (like the flipping of a coin) to one of two study drug groups, MBP8298 or inactive substance (placebo). You will have a 50:50 chance of receiving MBP8298. Neither you nor the study doctor or his/her staff will know which group you have been assigned to. However, in case of an emergency, the study doctor can find out if you were given MBP8298 or placebo.
Only if you are found to be HLA type DR2 and/or DR4 positive will you be able to continue with the screening process for participation in the study.
This study is open to enrollment. REQUEST INFORMATION.
Dr. Douglas Goodin from the Department of Neurology at the University of California, San Francisco, is participating in a medical research study sponsored by Novartis Pharmaceuticals Corporation. This project is investigating the efficacy, safety and tolerability of fingolimod (FTY720) in reducing the number of relapses in patients with relapsing-remitting multiple sclerosis (MS) treated for up to 2 years.
Current treatment for MS includes four approved drugs: Avonex® (interferon beta-la), Betaseron® (interferon beta-1b), Copaxone® (glatiramer acetate or co-polymer-1) and Rebif® (interferon beta-1a). All of these FDA-approved drugs have been shown to reduce the frequency and severity of relapses. Since some relapses will produce symptoms that do not completely improve, therapies that reduce the frequency of relapses may reduce the amount of disability or symptoms over time.
All of these drugs are injected into your body with a needle. Currently, there are no approved drugs (pills or liquids that you can swallow) that help patients with multiple sclerosis.
Fingolimod (FTY720) is an experimental oral drug that acts on the immune system, and that is not approved by the FDA for the treatment of MS. Taken once daily as a capsule, fingolimod acts on certain types of white blood cells that are responsible for immune reactions (lymphocytes). These cells are believed to play an important role in the inflammation process associated with MS. Fingolimod redirects a proportion of these cells from areas of inflammation and towards lymph nodes and other places in the body where they rest.
Previous studies conducted with fingolimod indicate the potential of using this drug in patients with MS; however, additional studies are needed to verify the efficacy, tolerability and side effects of this drug. Thus, if you choose to use fingolimod instead of one of the FDA-approved therapies, you may increase the risk of future disability, resulting in permanent damage to your nerves. Ask your study doctor to explain all of the benefits of FDA-approved drugs before you make this important decision.
Approximately 960 patients with relapsing-remitting MS will participate in this study at about 100 hospitals/clinics around the United States. At the UCSF MS Center, we expect that approximately 15 patients will be eligible to participate in the study.
Patients will be randomly assigned to one of the three treatments on the first day of the treatment:
You have an equal chance of being assigned to each treatment group. One third of all patients in the study will be assigned to the higher dose (1.25 mg), one third to the lower dose (0.5 mg), and one third to the placebo group.
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
Dr. Bruce Cree and his colleagues in the Department of Neurology at UCSF are conducting a study to investigate whether rituximab is safe to use in patients suffering from neuromyelitis optica (NMO), or who are at high risk for developing NMO (also known as "optic neuritis").
NMO means a disease like multiple sclerosis, where blindness and paralysis, bladder and sensation problems come from attacks of the immune system against the optic nerves and spinal cord. NMO is a special disease where antibodies made by B cells may cause your illness.
This is a research study of a product called rituximab that is FDA approved for some cancers. This product is only investigational in the sense that this is the first time this drug is being used for treatment of patients with NMO. Rituximab (MabThera®/Rituxan®) is a biological chemical produced by Genentech, Inc. and Biogen Idec Pharmaceuticals. Rituximab is not approved for recurrent myelitis and NMO and is therefore considered experimental for the purpose of this study. We need to ensure that use of rituximab is safe in your disease, and we hope to find out from this study whether or not it will be useful to stop attacks and the symptoms you have.
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.