New pill could slow MS relapses and disability
NCT ID NCT05156281
First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times
Summary
This Phase 3 trial tests whether the oral drug remibrutinib works better than teriflunomide at reducing relapses and slowing disability in people with relapsing multiple sclerosis. About 1,000 adults aged 18–55 with active MS are taking part. The study is double-blind, meaning neither participants nor doctors know who gets which drug, and will be followed by an open-label extension where everyone can receive remibrutinib.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- remibrutinib (a tablet taken by mouth)
- What this could lead to
- If successful, remibrutinib could offer a new oral treatment option for relapsing multiple sclerosis, potentially reducing relapses and slowing disability.
- What could go wrong
- This is a Phase 3 trial, but results are not yet available. It compares against an existing drug, so the benefit may be modest. Side effects are possible, and long-term safety is still being studied.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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1,007 people
The number who actually took part.
- Started
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Dec 2021
- Expected to finish
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Oct 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 18 to 55 years of age * Diagnosis of RMS according to the 2017 McDonald diagnostic criteria * At least: 1 documented relapse within the previous year. OR 2 documented relapses within the previous 2 years, OR 1 active Gadolinium (Gd)-enhancing lesion in the 12 months. * EDSS score of 0 to 5.5 (inclusive) * Neurologically stable within 1 month Exclusion Criteria: * Diagnosis of primary progressive multiple sclerosis (PPMS) * Disease duration of more than 10 years in participants with EDSS score of 2 or less at screening * History of clinically significant CNS disease other than MS * Ongoing substance abuse (drug or alcohol) * History of malignancy of any organ system (other than complete resection of localized basal cell carcinoma of the skin or in situ cervical cancer), * Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or Neurological symptoms consistent with PML * suicidal ideation or behavior * Evidence of clinically significant cardiovascular, neurological, psychiatric, pulmonary , renal, hepatic, endocrine, metabolic, hematological disorders or gastrointestinal disease that can interfere with interpretation of the study results or protocol adherence * Participants who have had a splenectomy * Active clinically significant systemic bacterial, viral, parasitic or fungal infections * Positive results for syphilis or tuberculosis testing * Uncontrolled disease states, such as asthma, or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids * Active, chronic disease of the immune system (including stable disease treated with immune therapy (e.g. Leflunomide, Methotrexate)) other than MS (e.g. rheumatoid arthritis, systemic lupus erythematosus, etc.) with the exception of well-controlled diabetes or thyroid disorder. * Participants with a known immunodeficiency syndrome (AIDS, hereditary immune deficiency, drug induced immune deficiency), or tested positive for HIV antibody * History or current treatment for hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis (including all Child-Pugh classes) or hepatic failure or any chronic liver or biliary disease. * History of severe renal disease or creatinine level * Participants at risk of developing or having reactivation of hepatitis * Hematology parameters at screening: * Hemoglobin: \< 10 g/dl (\<100g/L) * Platelets: \< 100000/mm3 (\<100 x 109/L) * Absolute lymphocyte count \< 800/mm3 (\<0.8 x 109/L) * White blood cells: \<3 000/mm3 (\<3.0 x 109/L) * Neutrophils: \< 1 500/mm3 (\<1.5 x 109/L) * B-cell count \< 50% lower limit of normal (LLN) or total IgG \& total IgM \< LLN (only required for participants who had a history of receiving B-cell therapies, such as rituximab, ocrelizumab or ofatumumab, prior to screening) * History or current diagnosis of significant ECG abnormalities * Resting QTcF ≥450 msec (male) or ≥460 msec (female) at pre-treatment as per central ECG reading at screening visit * Use of other investigational drugs * Requirement for anticoagulant medication or use of dual anti-platelet therapy Significant bleeding risk or coagulation disorders, * History of gastrointestinal bleeding * Major surgery within 8 weeks prior to screening * History of hypersensitivity to any of the study drugs or excipients * Pregnant or nursing (lactating) female participants, prior to randomization * Women of childbearing potential not using highly effective contraception * Sexually active males not agreeing to use condom * Have received any live or live-attenuated vaccines within 6 weeks of randomization or requirement to receive these vaccinations during study * Use of strong CYP3A4 inhibitors or use of moderate or strong CYP3A4 inducers within two weeks prior to randomization Inclusion to Extension part: • Participants who complete the Core Part of the study on double-blind study treatment and conduct the Accelerated Elimination Procedure (AEP) Other inclusion and exclusion criteria may apply.
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Get notified about this study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Advent Health Orlando
Orlando, Florida, 32803, United States
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Aqualane Clinical Research
Naples, Florida, 34105, United States
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Ascension St Francis Center
Milwaukee, Wisconsin, 53215, United States
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Baptist Physicians Lexington
Nicholasville, Kentucky, 40356, United States
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Baylor Scott and White
Temple, Texas, 76508, United States
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Brain and Spine Institute
Port Orange, Florida, 32127, United States
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CU Anschutz Med Campus
Aurora, Colorado, 80045, United States
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Caribbean Center for Clinical Research Inc
Guaynabo, 00968, Puerto Rico
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Clinre Comprehensive Neurology
Frederick, Maryland, 21702, United States
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Colorado Neurological Research PC
Denver, Colorado, 80210, United States
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Conquest Research
Winter Park, Florida, 32789, United States
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Ctr for Neurology and Spine
Phoenix, Arizona, 85018, United States
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Elligo Health Research
Crab Orchard, West Virginia, 25827, United States
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Emerald Coast Neurology
Pensacola, Florida, 32514, United States
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Gables Neurology
Miami, Florida, 33133, United States
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Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
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Georgetown University Hospital Research
Washington D.C., District of Columbia, 20007, United States
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Humanity Clinical Research
Pembroke Pines, Florida, 33024, United States
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Kansas City VA Medical Center
Kansas City, Missouri, 64128, United States
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Lone Star Neurology
Frisco, Texas, 75035, United States
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Lonestar Neurology of San Antonio
San Antonio, Texas, 78258, United States
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Med Research Inc
El Paso, Texas, 79935, United States
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Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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Memorial Healthcare System
Hollywood, Florida, 33021, United States
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Methodist Neuroscience Institute
Merrillville, Indiana, 46410, United States
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Metrolina Neurological Associates PA
Old Point Station, South Carolina, 29707, United States
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Neurology Associates PA
Maitland, Florida, 32751, United States
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Neurology Consultants Of Dallas PA
Dallas, Texas, 75231, United States
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Neurology Diagnostics Inc
Dayton, Ohio, 45408, United States
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New England Institute for Clinical Research
Stamford, Connecticut, 06905, United States
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Nova Clinical Research LLC
Bradenton, Florida, 34209, United States
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Novartis Investigative Site
Bombal, Mendoza Province, M5500DXO, Argentina
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Rosario, Santa Fe Province, S2000BZL, Argentina
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Rosario, Santa Fe Province, S2000DSW, Argentina
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San Miguel de, Tucumán Province, T4000, Argentina
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Buenos Aires, C1012AAR, Argentina
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CABA, C1181ACH, Argentina
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Córdoba, X5004CDT, Argentina
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Vitória, Espírito Santo, 29055-450, Brazil
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Brasília, Federal District, 70200-730, Brazil
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Curitiba, Paraná, 81210-310, Brazil
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Porto Alegre, Rio Grande do Sul, 90430-001, Brazil
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Porto Alegre, Rio Grande do Sul, 90560-032, Brazil
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Porto Alegre, Rio Grande do Sul, 90620-130, Brazil
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Joinville, Santa Catarina, 89202-165, Brazil
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São Paulo, 01240-020, Brazil
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Plovdiv, 4002, Bulgaria
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Sofia, 1309, Bulgaria
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Sofia, 1407, Bulgaria
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Sofia, 1431, Bulgaria
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Edmonton, Alberta, T6G 2B7, Canada
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Burnaby, British Columbia, V5G 2X6, Canada
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Halifax, Nova Scotia, B3H 4K4, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Lévis, Quebec, G6W 0M5, Canada
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Montreal, Quebec, H4A 3T2, Canada
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Québec, Quebec, G1J 1Z4, Canada
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Saint-Jérôme, Quebec, J7Z 5T3, Canada
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Wuhan, Hubei, 430030, China
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Wuhan, Hubei, 430060, China
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Nanjing, Jiangsu, 210029, China
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Yinchuan, Ningxia, 750004, China
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Taiyuan, Shanxi, 030001, China
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Hangzhou, Zhejiang, 310006, China
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Hangzhou, Zhejiang, 310016, China
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Wenzhou, Zhejiang, 325000, China
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Beijing, 100034, China
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Shanghai, 200025, China
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Shanghai, 200040, China
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Zagreb, Croatia, 10000, Croatia
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Split, HRV, 21000, Croatia
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Varaždin, HRV, 42000, Croatia
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Vukovar, Vukovar, 32000, Croatia
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Zagreb, 10000, Croatia
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Brno, 602 00, Czechia
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Hradec Králové, 500 05, Czechia
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Teplice, 415 29, Czechia
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Tallinn, 11315, Estonia
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Tartu, 50406, Estonia
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Limoges, Haute Vienne, 87000, France
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Toulon, Val De Marne, 83800, France
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Caen, 14033, France
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Clermont-Ferrand, 63003, France
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Dijon, 21000, France
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Gonesse, 95500, France
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Grenoble, 38043, France
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Lille, 59000, France
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Lille, 59037, France
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Nice, 06001, France
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Nîmes, 30029, France
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Poissy, 78303, France
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Toulouse, 31059, France
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Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
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Essen, 45147, Germany
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Hamburg, 22179, Germany
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Athens, 115 28, Greece
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Athens, 11526, Greece
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Chaïdári, 124 62, Greece
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Ioannina, 455 00, Greece
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Larissa, 411 10, Greece
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Thessaloniki, 53246, Greece
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Thessaloniki, 54636, Greece
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Kochi, Kerala, 682025, India
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Pune, Maharashtra, 411013, India
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New Delhi, National Capital Territory of Delhi, 110060, India
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Amritsar, Punjab, 143006, India
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Hyderabad, Telangana, 500082, India
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Lucknow, Uttar Pradesh, 226007, India
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Kolkata, West Bengal, 700017, India
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Brindisi, BR, 72100, Italy
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Foggia, FG, 71122, Italy
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Pozzilli, IS, 86077, Italy
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Messina, ME, 98124, Italy
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Modena, MO, 41126, Italy
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Pavia, PV, 27100, Italy
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Orbassano, TO, 10043, Italy
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Naples, 80138, Italy
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Nagoya, Aichi-ken, 4668560, Japan
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Chiba, Chiba, 2608677, Japan
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Ichihara, Chiba, 2990111, Japan
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Fukuoka, Fukuoka, 810-0022, Japan
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Sapporo, Hokkaido, 0630005, Japan
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Kobe, Hyōgo, 650-0017, Japan
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Nishinomiya, Hyōgo, 6638501, Japan
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Isehara, Kanagawa, 259-1193, Japan
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Sagamihara, Kanagawa, 252-0375, Japan
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Kyoto, Kyoto, 616-8255, Japan
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Sendai, Miyagi, 9838512, Japan
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Kashihara, Nara, 6348522, Japan
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Niigata, Niigata, 951-8520, Japan
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Moriguchi, Osaka, 570-8507, Japan
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Suita, Osaka, 565-0871, Japan
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Higashi-Matsuyama, Saitama, 355-0005, Japan
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Itabashi-ku, Tokyo, 1738610, Japan
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Kodaira, Tokyo, 187-8551, Japan
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Shinjuku Ku, Tokyo, 160-0023, Japan
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Shinjuku Ku, Tokyo, 1628666, Japan
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Shinjuku-ku, Tokyo, 1608582, Japan
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Fukuoka, 8128582, Japan
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Chihuahua City, Chihuahua, 31203, Mexico
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Mexico City, Mexico City, 06700, Mexico
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Mexico City, 14050, Mexico
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Querétaro, 76070, Mexico
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Plewiska, Poznan, 62-064, Poland
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Bialystok, 15-704, Poland
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Glogow Wielkopolski, 36-060, Poland
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Katowice, 40-081, Poland
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Katowice, 40-571, Poland
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Katowice, 40-686, Poland
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Katowice, 40-689, Poland
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Lublin, 20-701, Poland
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Wroclaw, 51-685, Poland
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Zabrze, 41-800, Poland
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Braga, 4710243, Portugal
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Coimbra, 3004-561, Portugal
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Leiria, 2410-197, Portugal
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Lisbon, 1169-050, Portugal
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Lisbon, 1649-035, Portugal
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Matosinhos Municipality, 4454-513, Portugal
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Santa Maria da Feira, 4520-211, Portugal
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Brasov, ROM, 500123, Romania
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Constanța, ROM, 900123, Romania
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Campulung Muscel, 115100, Romania
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Novartis Investigative Site
Constanța, 900591, Romania
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Banská Bystrica, 974 04, Slovakia
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Novartis Investigative Site
Banská Bystrica, 975 17, Slovakia
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Novartis Investigative Site
Bratislava, 833 05, Slovakia
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Novartis Investigative Site
Maribor, Slovenia, 2000, Slovenia
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Novartis Investigative Site
Celje, 3000, Slovenia
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Novartis Investigative Site
Ljubljana, 1000, Slovenia
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Bloemfontein, Free State, 9301, South Africa
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Pretoria, 0041, South Africa
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Rosebank, 2196, South Africa
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Santiago Compostela, A Coruna, 15706, Spain
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Novartis Investigative Site
Vitoria-Gasteiz, Araba, 01009, Spain
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Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
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Novartis Investigative Site
Albacete, Castille-La Mancha, 02006, Spain
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Novartis Investigative Site
Barcelona, Catalonia, 08003, Spain
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Novartis Investigative Site
Logroño, La Rioja, 26006, Spain
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Pozuelo de Alarcón, Madrid, 28223, Spain
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Torrejón de Ardoz, Madrid, 28850, Spain
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Gijón, Principality of Asturias, 33394, Spain
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Valencia, Valencia, 46017, Spain
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Lleida, 25198, Spain
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Madrid, 28009, Spain
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Madrid, 28040, Spain
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Málaga, 29016, Spain
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Seville, 41009, Spain
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Valencia, 46026, Spain
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Stockholm, 102 35, Sweden
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Samsun, Atakum, 55200, Turkey (Türkiye)
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Izmir, Balcova, 35340, Turkey (Türkiye)
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Istanbul, Fatih, 34093, Turkey (Türkiye)
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Novartis Investigative Site
Istanbul, Fatih, 34098, Turkey (Türkiye)
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Novartis Investigative Site
Izmir, Karabaglar, 35150, Turkey (Türkiye)
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Köseköy, Kocaeli, 41380, Turkey (Türkiye)
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Kayseri, Melikgazi, 38039, Turkey (Türkiye)
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Bursa, Nilufer, 16140, Turkey (Türkiye)
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Istanbul, Pendik, 34899, Turkey (Türkiye)
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Istanbul, Sancaktepe, 34785, Turkey (Türkiye)
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Konya, 42130, Turkey (Türkiye)
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Novartis Investigative Site
Inverness, Invernesshire, IV2 3RE, United Kingdom
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Novartis Investigative Site
Canterbury, Kent, CT1 3NG, United Kingdom
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Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
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Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
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Piedmont HealthCare
Charlotte, North Carolina, 28210, United States
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Premier Neurology
Greenville, South Carolina, 29605, United States
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Regina Berkovich MD PhD Inc
West Hollywood, California, 90048, United States
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Sibyl Wray MD Neurology PC
Knoxville, Tennessee, 37922, United States
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South Shore Neurologic Associates
Patchogue, New York, 11772, United States
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Texas Institute for Neurological Disorders
Sherman, Texas, 75092, United States
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The Boster Ctr for MS
Columbus, Ohio, 43235, United States
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Tufts Medical Center
Boston, Massachusetts, 02111, United States
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UM Department Of Neurology
Miami, Florida, 33136, United States
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UT Health MARC Medical Arts and Research Center
San Antonio, Texas, 78229, United States
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University Of NC At Chapel Hill
Chapel Hill, North Carolina, 27599 9500, United States
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University of Florida
Gainesville, Florida, 32610, United States
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University of Kansas Hospital
Kansas City, Kansas, 66160, United States
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University of Washington MS Clinic
Seattle, Washington, 98133, United States
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VA Greater LA Healthcare System
Los Angeles, California, 90073, United States
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Vero Beach Neurology
Vero Beach, Florida, 32960, United States
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Virginia Mason Medical Centre
Seattle, Washington, 98101, United States
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Vladimir Royter MD APMC
Hanford, California, 93230, United States
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