Study Description
To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with
relapsing multiple sclerosis (RMS) The study CLOU064C12301 consists of an initial Core Part (CP) (maximum duration per
participant of up to 30 months), followed by an Extension Part (EP, of up to 5 years
duration) for eligible participants.
The Core Part is a randomized, double-blind, double-dummy, active comparator-controlled,
fixed-dose, parallel-group, multi-center study in approximately 800 participants with
relapsing multiple sclerosis (RMS).
The Extension Part is an open-label, single-arm, fixed-dose design in which eligible
participants are treated with remibrutinib for up to 5 years.
A second study of identical design (CLOU064C12302) will be conducted simultaneously. Both
studies will be conducted globally and data from the two studies will be pooled for some
of the endpoints.
Interventions
Remibrutinib
Teriflunomide
Eligibility Criteria
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 or hepatic failure or participants with moderate or
severe hepatic impairment (Child-Pugh class C) 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 (prior to
randomization)
- 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
Study Location
Novartis Investigative Site
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Capital Federal,Buenos Aires,1424,Argentina
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Caba,C1424byd,Argentina
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Rosario,Santa Fe,2000,Argentina
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Caba,Buenos Aires,C1122aak,Argentina
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Buenos Aires,C1012aar,Argentina
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Capital Federal,C1023aab,Argentina
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Santiago del Estero,4200,Argentina
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Graz,A-8036,Austria
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Linz,4020,Austria
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Linz,Oberoesterreich,A 4020,Austria
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Brasschaat,2930,Belgium
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Pelt,3900,Belgium
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Ath,7800,Belgium
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Lier,2500,Belgium
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Brugge,8000,Belgium
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Bruxelles,1070,Belgium
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Melsbroek,1820,Belgium
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Edegem,Antwerpen,2650,Belgium
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Jette,Brussel,1090,Belgium
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Antwerpen,2018,Belgium
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Sofia,1113,Bulgaria
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Sofia,1431,Bulgaria
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Sofia,1680,Bulgaria
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Pleven,5800,Bulgaria
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Santiago,Region Metropolitana,7650568,Chile
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Santiago,Region Metropolitana,8431657,Chile
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Beijing,Beijing,100000,China
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Beijing,100029,China
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Hohhot,Inner Mongolia,010017,China
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Nanchang,Jiangxi,330006,China
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Tianjin,300052,China
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Beijing,100730,China
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Changchun,Jilin,130021,China
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Zhengzhou,Henan,450052,China
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Guangzhou City,Guangdong,510000,China
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Baotou,Inner Mongolia,014040,China
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Changsha,Hunan,410008,China
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Guangzhou,Guangdong,510080,China
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Chongqing,400016,China
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Bogota,110110,Colombia
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Puerto Colombia,Atlantico,080012,Colombia
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Cali,Valle Del Cauca,760001,Colombia
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Cali,Valle Del Cauca,760012,Colombia
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Zadar,23000,Croatia
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Osijek,31000,Croatia
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Zagreb,10000,Croatia
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Rijeka,HRV,51000,Croatia
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Slagelse,Dk-4200,Denmark
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Tbilisi,172,Georgia
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Tbilisi,179,Georgia
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Tbilisi,114,Georgia
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Tbilisi,141,Georgia
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Tbilisi,159,Georgia
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Tbilisi,160,Georgia
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Guatemala,01015,Guatemala
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Sha Tin,Hong Kong
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DehraDun,Uttarakhand,248001,India
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Mumbai,Maharashtra,400008,India
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Chandigarh,Punjab,160012,India
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Lucknow,Uttar Pradesh,226014,India
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Mangalore,575018,India
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Ludhiana,Punjab,141008,India
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Nashik,Maharashtra,422005,India
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New Delhi,Delhi,110017,India
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Dublin 4,Do4,Ireland
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Dublin,Dublin 8,Ireland
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Haifa,310 9601,Israel
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Ashkelon,78278,Israel
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Sefad,13100,Israel
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Hadera,38100,Israel
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Montichiari,BS,25018,Italy
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Novara,28100,Italy
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Napoli,80131,Italy
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Roma,RM,00133,Italy
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Roma,RM,00168,Italy
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Milano,MI,20132,Italy
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Verona,VR,37134,Italy
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Roma,RM,00189,Italy
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Amman,1857,Jordan
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Riga,Lv 1002,Latvia
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Riga,LV,Lv-1005,Latvia
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Ashrafieh,166830,Lebanon
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Tripoli,Crpj+66c,Lebanon
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Beirut,166378,Lebanon
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Beirut,6301,Lebanon
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El Chouf,LBN,1503201002,Lebanon
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Siauliai,LTU,76231,Lithuania
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Klaipeda,Lt-92288,Lithuania
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Seberang Jaya,Pulau Pinang,13700,Malaysia
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Kuala Lumpur,50589,Malaysia
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Kuala Terengganu,Terengganu,20400,Malaysia
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Rotterdam,3079 dz,Netherlands
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Wroclaw,Dolnoslaskie,52 416,Poland
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Lodz,93-113,Poland
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Kielce,25 726,Poland
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Lublin,20-410,Poland
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Rzeszow,35-323,Poland
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Piotrkow Trybunalski,97300,Poland
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Szczecin,70111,Poland
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Poznan,60-693,Poland
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Bydgoszcz,Woj Kujawsko-pomorskie,85-796,Poland
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Lodz,90 324,Poland
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Khorais Street,Riyadh,11426,Saudi Arabia
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Jeddah,21423,Saudi Arabia
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Jeddah,21499,Saudi Arabia
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Bratislava,82606,Slovakia
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Kosice,Slovak Republic,04066,Slovakia
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Trnava,917 75,Slovakia
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Nitra,94901,Slovakia
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La Coruna,Galicia,15006,Spain
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Madrid,28040,Spain
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El Palmar,Murcia,30120,Spain
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Vigo,Pontevedra,36212,Spain
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Las Palmas de Gran Canaria,35010,Spain
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Castilleja De La Cuesta,Sevilla,41950,Spain
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Madrid,28222,Spain
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Getafe,Madrid,28905,Spain
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Leon,24080,Spain
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Malaga,Andalucia,29010,Spain
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Cadiz,Andalucia,11009,Spain
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Salt,Cataluna,17190,Spain
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Alcorcon,Madrid,28922,Spain
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Sevilla,Andalucia,41014,Spain
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Madrid,28006,Spain
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Sant Joan Despi,Barcelona,08970,Spain
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Barcelona,08035,Spain
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Valencia,Comunidad Valenciana,46010,Spain
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Madrid,28034,Spain
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Cordoba,Andalucia,14004,Spain
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Bern,3010,Switzerland
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Basel,4031,Switzerland
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Taipei,11220,Taiwan
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Taoyuan,33305,Taiwan
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Kaohsiung,83301,Taiwan
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Tainan,70403,Taiwan
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Abu Dhabi,United Arab Emirates
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Westbruy On Trym,Bristol,Bs10 5nb,United Kingdom
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Winchester,Hampshire,So21 1hu,United Kingdom
Lahey Clinic
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Burlington,Massachusetts,01805,United States
Springfield Clinic Research
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Springfield,Illinois,62703,United States
Advocate Medical Group
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Park Ridge,Illinois,60068,United States
Neurostudies Inc
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Port Charlotte,Florida,33952,United States
Homestead Associates in Research Inc
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Miami,Florida,33032,United States
Velocity Clinical Research Drug Shipment
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Raleigh,North Carolina,27607,United States
Providence St Vincent Med Center
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Portland,Oregon,97225,United States
Neurological Associates of Long Island PC
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Lake Success,New York,11042,United States
Thomas Jefferson University Hospital Dept. of Neurology
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Philadelphia,Pennsylvania,19107-5098,United States
Christiana Care Health Services
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Newark,Delaware,19713,United States
Mid Atlantic Epilepsy and Sleep Ctr
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Bethesda,Maryland,20817,United States
Swedish Medical Center Swedish Neuroscience Research
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Seattle,Washington,98122,United States
Allied Physicians, Inc. .
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Fort Wayne,Indiana,46845,United States
North TX Inst of Neuro and Headache
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Plano,Texas,75024,United States
Washington Hospital Center Research Site Shipment
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Washington,District of Columbia,20010,United States
Honor Health Research Institute .
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Scottsdale,Arizona,85258,United States
Orlando Health Clinical Trials .
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Orlando,Florida,32806,United States
Reading Hospital Tower Health Med Group Neuro
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Reading,Pennsylvania,19611,United States
University of Pittsburgh Medical Ctr Magee - Womens Hospital
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Pittsburgh,Pennsylvania,15213,United States
College Park Family Care Center
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Overland Park,Kansas,66210,United States
Mountain Neuro Research Center PC .
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Basalt,Colorado,81621,United States
Norton Neurology MS Services
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Louisville,Kentucky,40207,United States
Texas Neurology
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Dallas,Texas,75206,United States
Alpine Clinical Research Center
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Boulder,Colorado,80301,United States
Insight Hospital and Medical Center
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Chicago,Illinois,60616,United States
Neurology Associates of Ormond Beach
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Ormond Beach,Florida,32174,United States
Reliant Medical Research
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Miami,Florida,33165,United States
University of South Florida .
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Tampa,Florida,33612,United States
Comprehensive Neurology Clinic
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Orlando,Florida,32825,United States
MS Center of Greater Washington, P.C.
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Vienna,Virginia,22182,United States
The MS Center for Innovation in Care .
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Saint Louis,Missouri,63131,United States
Axiom Clinical Research of Florida
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Tampa,Florida,33609,United States
International Neurorehab Institute .
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Lutherville,Maryland,21093,United States
Neurology Center of New England PC .
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Foxboro,Massachusetts,02035,United States
Rush University Medical Center CFTY720D2312
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Chicago,Illinois,60612,United States
University of Wisconsin Madison
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Madison,Wisconsin,53792,United States
DHR Health Institute .
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McAllen,Texas,78503,United States
Multiple Sclerosis Center of Excellence of OMRF
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Oklahoma City,Oklahoma,73104,United States
NYU Langone Med Center CV Research .
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New York,New York,10016,United States
The Neurological Institute PA
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Charlotte,North Carolina,28204,United States
AZ Integrated Neuro and Spine Integrated MS Center
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Phoenix,Arizona,85037,United States
Jersey Shore University Medical Ctr
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Neptune,New Jersey,07753,United States
Neurology of Central FL Res Ctr
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Altamonte Springs,Florida,32714,United States
SC3 Research Pasadena
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Pasadena,California,91105,United States
US Associates in Research
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Miami,Florida,33175,United States
Glendale Adventist Medical Center Research
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Glendale,California,91206,United States
Neur Ctr of N Orange County
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Fullerton,California,92835,United States
The Neuron Clinic .
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Chula Vista,California,91910,United States
Beth Israel Deaconess Medical Cente
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Boston,Massachusetts,02215,United States
John Peter Smith Hospital
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Fort Worth,Texas,76104,United States
Accel Research Sites St Pete-Largo
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Seminole,Florida,33777,United States
Neuroscience Group
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Neenah,Wisconsin,54956,United States
SCL Health
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Billings,Montana,59101,United States
Velocity Clinical Research
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Savannah,Georgia,31406,United States
Hoag Health System
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Newport Beach,California,92663,United States
Palmetto Clinical Research .
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Summerville,South Carolina,29485,United States
Neuro Eye Clinical Trials Inc
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Houston,Texas,77074,United States
Center for Neurosciences
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Tucson,Arizona,85718,United States
The Research and Education Inst. of Alta Bates Summit Med. Grp
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Berkeley,California,94705,United States
Worldwide Contacts
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