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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Caba,Buenos Aires,C1122AAK,Argentina
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Rosario,Santa Fe,2000,Argentina
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Buenos Aires,C1012AAR,Argentina
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Capital Federal,C1023AAB,Argentina
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Capital Federal,Buenos Aires,1424,Argentina
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Caba,C1424BYD,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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Lier,2500,Belgium
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Ath,7800,Belgium
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Brugge,8000,Belgium
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Pelt,3900,Belgium
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Bruxelles,1070,Belgium
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Edegem,Antwerpen,2650,Belgium
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Jette,Brussel,1090,Belgium
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Melsbroek,1820,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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Hohhot,Inner Mongolia,010017,China
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Beijing,100029,China
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Beijing,100730,China
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Changchun,Jilin,130021,China
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Nanchang,Jiangxi,330006,China
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Guangzhou City,Guangdong,510000,China
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Tianjin,300052,China
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Changsha,Hunan,410008,China
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Baotou,Inner Mongolia,014040,China
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Guangzhou,Guangdong,510080,China
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Chongqing,400016,China
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Zhengzhou,Henan,450052,China
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Beijing,Beijing,100000,China
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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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Bogota,110110,Colombia
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Osijek,31000,Croatia
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Rijeka,HRV,51000,Croatia
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Zadar,23000,Croatia
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Zagreb,10000,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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Chandigarh,Punjab,160012,India
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Mumbai,Maharashtra,400008,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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DehraDun,Uttarakhand,248001,India
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Dublin 4,DO4,Ireland
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Dublin,DUBLIN 8,Ireland
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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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Haifa,310 9601,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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Beirut,166378,Lebanon
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Tripoli,CRPJ+66C,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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Kielce,25 726,Poland
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Lublin,20-410,Poland
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Rzeszow,35-323,Poland
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Wroclaw,Dolnoslaskie,52 416,Poland
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Piotrkow Trybunalski,97300,Poland
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Bydgoszcz,Woj Kujawsko-pomorskie,85-796,Poland
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Lodz,90 324,Poland
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Szczecin,70111,Poland
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Poznan,60-693,Poland
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Lodz,93-113,Poland
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Jeddah,21423,Saudi Arabia
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Jeddah,21499,Saudi Arabia
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Khorais Street,Riyadh,11426,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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Getafe,Madrid,28905,Spain
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Madrid,28222,Spain
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Vigo,Pontevedra,36212,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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Alcorcon,Madrid,28922,Spain
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Madrid,28006,Spain
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Salt,Cataluna,17190,Spain
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Barcelona,08035,Spain
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Sevilla,Andalucia,41014,Spain
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Madrid,28034,Spain
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Cordoba,Andalucia,14004,Spain
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Sant Joan Despi,Barcelona,08970,Spain
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Valencia,Comunidad Valenciana,46010,Spain
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La Coruna,Galicia,15006,Spain
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El Palmar,Murcia,30120,Spain
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Madrid,28040,Spain
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Castilleja De La Cuesta,Sevilla,41950,Spain
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Las Palmas de Gran Canaria,35010,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
Novartis Investigative Site
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Winchester,Hampshire,SO21 1HU,United Kingdom
Christiana Care Health Services
Recruiting
Newark,Theresa Whitehead Izwylde (+1 302 623 3844) email: [email protected] -- Jason M Silversteen,19713 - Delaware,United States
Rush University Medical Center CFTY720D2312
Recruiting
Chicago,Elizabeth Dvorak (708-216-2662) email: [email protected] -- Thomas Shoemaker,60612 - Illinois,United States
University of Wisconsin Madison
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Madison,Amy Nagel (608-265-6544) email: [email protected] -- Natasha Frost,53792 - Wisconsin,United States
Mid Atlantic Epilepsy and Sleep Ctr
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Bethesda,Ivana Tyrlikova (301-530-9744) email: [email protected] -- Jonathan Ross,20817 - Maryland,United States
Allied Physicians, Inc. .
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Fort Wayne,Olivia Vincent email: [email protected] -- Ajay Gupta,46845 - Indiana,United States
NYU Langone Med Center CV Research .
Recruiting
New York,Miguel Rodriguez (718-630-7303) email: [email protected] -- Nada Abou-Fayssal,10016 - New York,United States
North TX Inst of Neuro and Headache
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Plano,Kinza Idris (972-403-8184) email: [email protected] -- Annette Okai,75024 - Texas,United States
Honor Health Research Institute .
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Scottsdale,Marissa Bielecki email: [email protected] -- Suraj Muley,85258 - Arizona,United States
The Neurological Institute PA
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Charlotte,Jada Russell (+1 704 449 6064) email: [email protected] -- T Hemanth Hemanth Rao,28204 - North Carolina,United States
Orlando Health Clinical Trials .
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Orlando,Thomas Melendez (407-352-5434) email: [email protected] -- Amparo Gutierrez,32806 - Florida,United States
College Park Family Care Center
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Overland Park,Denise Halvorsen (913-469-9887) email: [email protected] -- Jeffrey Kaplan,66210 - Kansas,United States
SC3 Research Pasadena
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Pasadena,Austin Sun (626-250-2070) email: [email protected] -- M Lorraine Purino,91105 - California,United States
Mountain Neuro Research Center PC .
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Basalt,Leslia Serrano email: [email protected] -- Alison Brooke Allen,81621 - Colorado,United States
US Associates in Research
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Miami,Jhenny Grullon (786-275-4023) email: [email protected] -- Christopher Jimenez,33175 - Florida,United States
Alpine Clinical Research Center
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Boulder,Devin Sharp (303-443-7229) email: [email protected] -- Sidarth Dasari,80301 - Colorado,United States
Norton Neurology MS Services
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Louisville,(502-899-6782) -- Geeta Ganesh,40207 - Kentucky,United States
Insight Hospital and Medical Center
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Chicago,Agatha Ngwueke email: [email protected] -- Rany A Aburashed,60616 - Illinois,United States
The Neuron Clinic .
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Chula Vista,Daniel Arevalo (951-383-3028) email: [email protected] -- Jose Soria,91910 - California,United States
Neurology Associates of Ormond Beach
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Ormond Beach,Suzanne Powell (386-676-6340) email: [email protected] -- James Scott,32174 - Florida,United States
Comprehensive Neurology Clinic
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Orlando,Elliuz Leal (407-913-9120) email: [email protected] -- Refaat El-Said,32825 - Florida,United States
SCL Health
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Billings,Amanda Klein email: [email protected] -- Kristian French,59101 - Montana,United States
MS Center of Greater Washington, P.C.
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Vienna,Rebeca Marin (703-226-4000) email: [email protected] -- Heidi Crayton,22182 - Virginia,United States
Velocity Clinical Research
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Savannah,Leila Hennon (912-790-4837) email: [email protected] -- J Michael Hemphill,31406 - Georgia,United States
Palmetto Clinical Research .
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Summerville,Gino Pineda (843-851-7098) email: [email protected] -- Robert Carlile,29485 - South Carolina,United States
Axiom Clinical Research of Florida
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Tampa,Haitham Abulaban (813-353-9613) email: [email protected] -- Mark Cascione,33609 - Florida,United States
International Neurorehab Institute .
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Lutherville,Ukeme Ikiddeh-Barnes (410-828-4629) email: [email protected] -- Daniel Becker,21093 - Maryland,United States
The Research and Education Inst. of Alta Bates Summit Med. Grp
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Berkeley,Yomi Kapasi (510-849-0417) email: [email protected] -- Deepak Soneji,94705 - California,United States
Neurology Center of New England PC .
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Foxboro,Emily Maize (781-551-5812) email: [email protected] -- Salvatore Napoli,02035 - Massachusetts,United States
Springfield Clinic Research
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Springfield,Sue Sutherland email: [email protected] -- Reuben Valenzuela,62703 - Illinois,United States
DHR Health Institute .
Recruiting
McAllen,Adreinne Casciato (+1 956 362 2391) email: [email protected] -- Roberto Alejandro Cruz,78503 - Texas,United States
Multiple Sclerosis Center of Excellence of OMRF
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Oklahoma City,(405-271-6242) -- Gabriel Pardo,73104 - Oklahoma,United States
Velocity Clinical Research Drug Shipment
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Raleigh,Tracey Pate (919-719-8826) email: [email protected] -- Casey Jeffreys,27607 - North Carolina,United States
Providence St Vincent Med Center
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Portland,Sara Guedry (503-297-9142) email: [email protected] -- Stanley Cohan,97225 - Oregon,United States
AZ Integrated Neuro and Spine Integrated MS Center
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Phoenix,Brandon Mc Cravey email: [email protected] -- Barry Hendin,85037 - Arizona,United States
Thomas Jefferson University Hospital Dept. of Neurology
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Philadelphia,Angira Mathur (215-955-6939) email: [email protected] -- Thomas Leist,19107-5098 - Pennsylvania,United States
Jersey Shore University Medical Ctr
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Neptune,Tyler Madsen (732-776-4782) email: [email protected] -- Lana Zhovtis Ryerson,07753 - New Jersey,United States
Neurology of Central FL Res Ctr
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Altamonte Springs,Yohana Gonzalez (407-790-4990) email: [email protected] -- Alicia Cabrera,32714 - Florida,United States
Swedish Medical Center Swedish Neuroscience Research
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Seattle,Laura Johnson email: [email protected] -- Pavle Repovic,98122 - Washington,United States
Glendale Adventist Medical Center Research
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Glendale,Javier Valeriano (808-409-8009) email: [email protected] -- Artin Minaeian,91206 - California,United States
Washington Hospital Center Research Site Shipment
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Washington,Petros Okubagzi (202-877-6607) email: [email protected] -- Brian Barry,20010 - District of Columbia,United States
Neur Ctr of N Orange County
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Fullerton,Sheraz Mossa email: [email protected] -- Anthony Ciabarra,92835 - California,United States
Reading Hospital Tower Health Med Group Neuro
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Reading,Mary Elle Alderfer (484-628-8814) email: [email protected] -- Clifford Reed,19611 - Pennsylvania,United States
Beth Israel Deaconess Medical Cente
Recruiting
Boston,Alexandra Balshi (617-667-7000) email: [email protected] -- Jacob Sloane,02215 - Massachusetts,United States
University of Pittsburgh Medical Ctr Magee - Womens Hospital
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Pittsburgh,Aimee Steiner (412-641-3418) email: [email protected] -- Ingrid Loma-Miller,15213 - Pennsylvania,United States
John Peter Smith Hospital
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Fort Worth,Anna Diaz email: [email protected] -- Horacio Chiong-Rivero,76104 - Texas,United States
Neuroscience Group
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Neenah,Thomas Mayo (920-725-9373) email: [email protected] -- Daniel Long,54956 - Wisconsin,United States
Accel Research Sites St Pete-Largo
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Seminole,Patricia Hanson email: [email protected] -- Deborah Burke,33777 - Florida,United States
Texas Neurology
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Dallas,(214-824-6434) -- Arun Nagaraj,75206 - Texas,United States
Hoag Health System
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Newport Beach,Rachel Romansik (800-400-4624) email: [email protected] -- Yasir Jassam,92663 - California,United States
Neuro Eye Clinical Trials Inc
Recruiting
Houston,Laura Perez (713-942-2187) email: [email protected] -- Rosa Tang,77074 - Texas,United States
Reliant Medical Research
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Miami,Najania Ortega Morejon (786-801-0912) email: [email protected] -- Carlos Ramirez-Calderon,33165 - Florida,United States
Center for Neurosciences
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Tucson,Crystal Placencia (520-320-2147) email: [email protected] -- Francisco Valdivia,85718 - Arizona,United States
University of South Florida .
Recruiting
Tampa,Dowen Hampton (813-974-9423) email: [email protected] -- Derrick Robertson,33612 - Florida,United States
Lahey Clinic
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Burlington,Amanda Diederich (+1 781 744 2500) email: [email protected] -- Dan Michael Pineda,01805 - Massachusetts,United States
Advocate Medical Group
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Park Ridge,Victor Arroyo (847-825-1100) email: [email protected] -- Danielle Rice,60068 - Illinois,United States
Neurostudies Inc
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Port Charlotte,(941-764-0800) -- Liliana Montoya,33952 - Florida,United States
The MS Center for Innovation in Care .
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Saint Louis,(314-996-7960) -- Barry A Singer,63131 - Missouri,United States
Homestead Associates in Research Inc
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Miami,Jhenny Grullon (305-246-0873) email: [email protected] -- Angel Carrasco,33032 - Florida,United States
Neurological Associates of Long Island PC
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Lake Success,Isaac Roman (516-466-4700) email: [email protected] -- Teresa DeAngelis,11042 - New York,United States
Worldwide Contacts
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