Mellen Center Currently Enrolling Non-Treatment Trials STRATIFY-2 JCV Antibody Program in Patients with Relapsing Multiple Sclerosis Receiving or Considering Treatment with Tysabri Primary Investigator: Jeffrey A. Cohen, M.D. Purpose: This study will test whether the presence of antibodies to JC virus (JCV), the virus that causes progressive multifocal leukoencephalopathy (PML), is an accurate indicator of JCV infection. PML is a rare, serious complication of Tysabri therapy. All patients with relapsing MS treated with Tysabri or who are considering beginning treatment with Tysabri are eligible to participate. Patients who are about to begin treatment with Tysabri may enroll into STRATIFY-2 prior to enrolling into the TOUCH Prescribing Program. Patients participating in any other Tysabri clinical trial or study sponsored by Biogen Idec or Elan may not participate in this study. Subjects will participate. A blood sample will be collected annually for up to for JCV antibody testing. For more information please contact Vinette Zinkand, RN at zinkanv@ccf.org or 216 444 4817 Impact of a Hip Flexion Assist Device on Gait Performance in Multiple Sclerosis Patients. Primary Investigator: Francois Bethoux MD Volunteers ages 18-60 years that have MS and difficulty walking due to hip flexor weakness. Volunteers in this study will be asked to participate in four study visits over nine weeks for two hours of their time. The purpose of the research study is to determine the benefits of the use of a hip flexion assist device (brace) in ambulatory patients with hip flexor weakness and to determine the effect of the device (brace) on walking performance. If you agree to participate in this study you will be randomly assigned to either the control group (no brace during the 8 weeks of the study), or the treatment group (fitted for the brace at enrollment). That is, you will have a 50% chance of being in the control group (no brace during 8 weeks of - 1
the study) and a 50% chance of being in the treatment group (wear the brace for the 8 weeks of the study). If you are assigned to the brace at enrollment you will go home with the device, and written instructions will be provided and you will then return for a brace adjustment one week later. If you are in the control group you will be fitted with the brace eight weeks after enrollment, you will go home with the device, written instructions will be provided, and you will then return in one week for a brace adjustment. Both groups will have study evaluations done at four and eight weeks after enrollment. Evaluations will be done by two separate clinicians. The treating clinician will fit the brace and do evaluations with or without the brace for both groups. The other will be called the blinded clinician, which means that he/she will be unaware of the randomization of the patients, and will repeat the same evaluations with no brace. These evaluations will include: manual muscle testing (an examination of muscle strength) and Modified Ashworth Scale (an examination of stiffness) in both lower extremities, numeric pain rating (a scoring system for possible discomfort in legs), timed 25-foot walk, 2-minute walk (measurement of distance that can be achieved within 2 minutes). Other information to be gathered in the study will include: demographics (age, sex, race/ethnicity), disease characteristics (date of symptom onset, date of diagnosis, clinical course at onset, current clinical course), active co morbidities, medications, height, weight, and several questionnaires about your walking. You will be asked to fill out a diary of your brace usage, exercise at home, and any comments. Adverse events will be assessed in person during study visits, and by weekly phone calls from week 2 to week 8. For more information please contact Darlene Stough RN stoughd@ccf.org or 216 445-5877 Co-Investigators: Multidisciplinary Research in Biofeedback Francois Bethoux MD and Mary Rensel MD MS volunteers ages 18 to 80 years old to participate in a pilot study evaluating the effects of biofeedback-mediated stress management in patients with fatigue interfering with activities. Volunteers must have the ability to walk 50 feet independently with or without the use of walking aides. Volunteers in this study will be asked to participate in ten study visits for one to two hours of their time and will receive financial compensation for their time and travel. - 2
To help examine the effectiveness of the biofeedback sessions on MS symptoms at both visit one and ten, we will collect blood samples along with information on your disease and symptoms, questionnaires on depression, fatigue and health status, the Multiple Sclerosis Functional Composite (MSFC, a test of walking performance, hand function and cognition) will also be performed. Biofeedback training and monitoring of physiology will also be performed at all visits. No experimental procedures are involved in this study. For more information please contact Darlene Stough RN stoughd@ccf.org or 216 445-5877 Functional and Structural MRI Assessment of Visual Recovery Following Acute Optic Neuritis The goal of the study is to learn about changes in the vision pathways in the brain after optic neuritis using magnetic resonance imaging (MRI). Primary Investigator: Robert Bermel, M.D. Optic neuritis in one eye as a clinical episode of CIS or Relapsing Remitting MS Neurological exam, Optical exam and a MRI every 6months For more information, please contact Tammy Skaramagas at skaramt1@ccf.org Genetics Study This study s goal is to determine what predisposes people to develop MS on a genetic level. This study is sponsored by the National Institutes of Health, National Multiple Sclerosis Society, Mathers Foundation, and Nancy Davis Foundation. Primary Investigator: Lael Stone, M.D. African American patients with MS and their family members if possible. Caucasian MS patients and their parents and any other family member or friends with or without MS One study visit only A one time Blood draw and questionnaire For more information please contact Vinette Zinkand, RN at zinkanv@ccf.org or 216 444 4817-3
Brain Tissue: A tissue bank for MS brain and spinal cord, which includes post-mortem MR imaging. Enrollment either during life or immediately after death. This study will help us have a better understanding this disease and give our researcher vital information that may led to better treatments in the future. Primary Investigator: Robert Fox, M.D. Assessments: Any one with MS can participate. MRI imaging and tissue bank for MS brain and spinal cord after death For more information, please contact Cynthia Schwanger, RN, BSN at schwanc@ccf.org or 216 445-5788 MRI studies We have several different MRI imaging studies that will give us insight into how MS changes not only the structure of the brain and spinal cord but how they function. Primary Investigator: Mark Lowe, PhD Assessments: We are in need of both people with MS and healthy people to volunteer for MRI studies. This study requires one visit to the Mellen Center MRI Center for a MRI and a neurological test. For more information, please contact, Katie Murphy at rossk@ccf.org or 216-445-3281 Ongoing Research at the Mellen Center (Not Enrolling) CARE MS II This study, seeks to compare the effect of alemtuzumab to Rebif on MSrelated disability, relapses, and harmful effects on the brain that patients with MS may experience. This study also seeks to examine any side effects patients may experience when taking alemtuzumab or Rebif. This study is being sponsored by the Genzyme Corporation Primary Investigator: Jeffrey Cohen, M.D. at least 2 or more MS attacks occurring in the prior to screening, - 4
with 1 or more MS attacks in the 1 year prior to screening. Participant must have been on Must have been on Avonex, Copaxone or Betaseron in the past 5 years for MS. 1) High dose Alemtuzumab 2) Low dose Alemtuzumab 3) Rebif 3 MRI s and 10 neurological exams For more information, please contact, Vinette Zinkand, RN at zinkanv@ccf.org or 216 444-4817 CombiRx: The goal of this study is to find out if combination of interferon beta 1-a (Avonex ) and glatiramer acetate (Copaxone ) is an effective therapy for RRMS and better than either therapy alone. This study is sponsored by the National Institutes of Health. Primary Investigator: Lael Stone, M.D. Entry requirements at least 2 relapses in the prior 3 years 3 years plus Avonex, Copaxone or both 5 MRI s, 4 neurological exams, 2 EKGs For more information, please contact, Vinette Zinkand, RN at zinkanv@ccf.org or 216-444-4817 BRAVO The purpose of this study is to assess the efficacy, safety and tolerability of laquinimod compared to Avonex and placebo. Laquinimod is a daily oral agent under development by Teva Pharmaceutical Industries, Ltd. Primary Investigator: Jeffrey Cohen, M.D. at least 2 relapses in the prior before screening or one relapses in the past year or one relapse between 1 and before screen with an active lesions on MRI in the past year - 5
1. Laquinimod 0.6 mg once daily (oral medication) 2. Matching placebo (for laquinimod) once daily 3. Avonex 30 mcg intramuscular injection once weekly MRI s, neurological exams and lab work For more information, please contact Cynthia Schwanger RN BSN at schwanc@ccf.org or 216-445-5788 CONFIRM The purpose of this study is to find out if treatment with BG00012 can decrease the number of MS relapses over the course of the study, can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for the disease to get worse. Primary Investigator: Robert Fox, M.D. at least 1 or more relapses in the prior 12 months or 1 or more active lesions in the 6 weeks prior to randomization Low-dose BG-12 High-dose BG-12 Copaxone Placebo 4 MRI s, 10 neurological exams, 6 EKGs For more information, please contact Cynthia Schwanger, RN, BSN at schwanc@ccf.org or 216-445-5788 Name: PI: Key Entry Criteria: TYGRIS The purpose of this study is to better understand the drug natalizumab (Tysabri). This study is sponsored by Biogen Idec. Robert Fox, M.D. Any MS pt on Tysabri for less than 3 months This study will provide long term follow up information about patients on Tysabri - 6
5 years Study Assessments include: A questionnaire every 3 months. For more information, please contact, Vinette Zinkand, RN at zinkanv@ccf.org or 216 444 4817-7