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 at zinkanv@ccf.org or 216 444 4817 The Effects of Rhythmic Auditory Stimulation in Patients with MS Primary Investigator: Francois Bethoux MD Volunteers ages 18-60 years and old that have difficulty walking. Volunteers must have the ability to walk 100 feet independently with or without the use of walking aides. Volunteers in this study will be asked to participate in six study visits over six weeks for two hours of their time, and participate in 20 min. daily of a home based walking program. Volunteers will receive financial compensation for their time and travel. To help examine the effectiveness of the intervention of rhythmic auditory stimulation via a home based walking program. Measurements of your gait will be taken at each study visit. These measurements will be computed by the GaitRite system. The GaitRite system consists of a mat with sensors, which records the pattern of gait when somebody walks on it. Other - 1
information to be gathered in the study will include: demographics, medical and disease history, test of muscle strength and spasticity, MS Functional Composite (MSFC), a three part scale including a walking test (Timed 25-Foot Walk), a hand function test (Nine Hole Peg Test), and a memory test (Paced Auditory Serial Addition Test or PASAT), MS Walking Scale (MSWS-12) Self-report scale, which includes 12 questions regarding the impact of MS on your walking abilities, and a videotape of your walking. RAS training will consist of the music therapist providing a list of songs and you will be asked to choose at least 5 songs from this list. Each song has had an embedded beat added to it. The Music Therapist will use the software program SONY ACID Music to ensure that the cadence (tempo) of these songs is 10% above your initial baseline cadence. These songs will then be downloaded into an MP3 player and given to you for the next 4 weeks (or 1 week if you are in the control group). During this time period you will be required to walk to the music 20 minutes a day. If you agree to participate in this study you will be randomized to receive either the treatment group who participate in the home based walking for four of the six weeks or the control group who only participate in the home based walking one of the six weeks. These groups will perform the same tests you have equal chance of being in either group. 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 - 2
Primary Investigator: Lael Stone, M.D. 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. 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 at zinkanv@ccf.org or 216 444 4817 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 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. - 3
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, 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 at zinkanv@ccf.org or 216 444-4817 Name: PI: Key Entry Criteria: Treatment groups Ocrelizumab The purpose of this study is to prove wither ocrelizumab will stabilize, or potentially improve, the clinical course of your MS This study is sponsored by Roche/Genentech. Robert Fox, M.D. RRMS with 1 relapse in the past year and 2 relapses in the past. Plus a qualifying MRI plus Ocrelizumab 100mg Ocrelizumab 600mg Placebo Avonex Everyone will be on Ocrelizumab after 6 months - 4
Study Assessments include: 10 MRI s and 10 neurological exams and safety lab work For more information, please contact, Vinette Zinkand 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 at zinkanv@ccf.org or 216-444-4817 Biomarkers in MS This study is to determine a better understand on how Avonex works. This study is sponsored by the National Institutes of Health Primary Investigator: Richard Rudick, M.D. Participants must have Relapsing Remitting MS or Clinically Isolated Syndrome (CIS) (at high risk to develop MS) If you have been diagnosed with MS within past 5 years and are starting Interferon (Avonex ) treatment for the first time. MRI and blood draws For more information please contact Dee Ivancic at ivancid@ccf.org or 216 444 5441 TRANSFORMS extension This study is to provide efficacy, safety and tolerability data on fingolimod compared to Avonex in pt with RRMS This study is sponsored by Novartis. - 5
Primary Investigator: Jeffrey A. Cohen, M.D. Key Entry Criteria: RRMS with 1 relapse in the past year or 2 relapses in the past 1 year 1.25 mg fingolimod daily (1 capsule a day) AND intramuscular injection once weekly of placebo ( inactive injection ) for 12 months. 0.5 mg fingolimod daily (1 capsule a day) AND intramuscular injection once weekly of placebo ( inactive injection ) for 12 months. Avonex (30 mcg interferon beta-1a by intramuscular injection once weekly) AND 1 capsule a day of placebo ( inactive pill ) for 12 months. Ophthalmic exam, EKG, MRI, Pulmonary Function Tests, Neurological exam, Chest High Resolution Computer Tomography, Echocardiography For more information, please contact Cynthia Schwanger at schwanc@ccf.org or 216 445-5788 Expected completion: 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 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 at schwanc@ccf.org or 216-445-5788 CONFIRM - 6
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 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 5 years Study Assessments include: A questionnaire every 3 months. For more information, please contact, Vinette Zinkand at zinkanv@ccf.org or 216 444 4817-7