An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod to Ofatumumab

Last updated: May 9, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Multiple Sclerosis

Scar Tissue

Memory Loss

Treatment

Ofatumumab

Clinical Study ID

NCT04353492
COMB157G23101
2019-001341-40
  • Ages 18-60
  • All Genders

Study Summary

Open-label study to evaluate the effectiveness of treatment with ofatumumab in subjects transitioning from any fumarate-based RMS approved therapy or fingolimod due to breakthrough disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of MS according to the 2017 Revised McDonald criteria

  • Relapsing MS: relapsing forms of MS (RMS) including RMS and secondary progressive MS (SPMS)

  • Disability status at screening defined by Expanded Disability Status Scale (EDSS)score of 0 to 4 (inclusive)

  • MS treatment history with a maximum of 3 Disease Modifying Therapies (DMTs), whereall fumarates are considered as one DMT

  • Subject transitioning from either any fumarate-based RMS approved therapies, such asdimethyl fumarate (DMF) or diroximel fumarate (DRF), or fingolimod which wasadministered for a period of at least 6 months, as their last DMT before first studydrug administration

  • Breakthrough disease activity while the participant was adequately using fumaratesor fingolimod prior to transitioning for a minimum of 6 months as evidenced by oneor more clinically reported relapses or one or more signs of Magnetic ResonanceImaging (MRI) activity (e.g. Gd+ enhancement, new or enlarging T2 lesions)

  • Neurologically stable within one month prior to first study drug administration

Exclusion

Exclusion Criteria:

  • Subjects with primary progressive MS or SPMS without disease activity

  • Subjects meeting criteria for neuromyelitis optica

  • Disease duration of more than 10 years since diagnosis

  • Pregnant or nursing (lactating) women

  • Women of child-bearing potential unless they are using highly effective forms ofcontraception during dosing and for at least 6 months after stopping studymedication

  • Subjects with active chronic disease of the immune system other than MS or withimmunodeficiency syndrome

  • Subjects with active systemic bacterial, fungal or viral infections (such ashepatitis, HIV, COVID-19), or known to have Acquired Immunodeficiency Syndrome (AIDS)

  • Subjects with neurological symptoms consistent with Progressive MultifocalLeukoencephalopathy (PML) or with confirmed PML

  • Subjects at risk of developing or having reactivation of syphilis or tuberculosis (e.g. subjects with known exposure to, or history of syphilis, or active or latenttuberculosis, even if previously treated), as confirmed by medical history or perlocal practice

  • Subjects with active hepatitis B and C disease, assessed locally

  • Have received any live or live-attenuated vaccines within 4 weeks prior to firststudy drug administration

  • Have been treated with medications as specified or within timeframes specified (e.g.corticosteroids, ofatumumab, rituximab, ocrelizumab, alemtuzumab, natalizumab,daclizumab, cyclophosphamide, teriflunomide etc.)

  • Subjects suspected of not being able or willing to cooperate or comply with studyprotocol requirements in the opinion of the investigator

Study Design

Total Participants: 562
Treatment Group(s): 1
Primary Treatment: Ofatumumab
Phase: 3
Study Start date:
July 14, 2020
Estimated Completion Date:
March 11, 2025

Study Description

This is a single arm, prospective, multicentre and open-label, 96-week study to evaluate the treatment effectiveness of ofatumumab (OMB) in subjects with relapsing multiple sclerosis (RMS) transitioning from fumarate-based RMS approved therapies, such as dimethyl fumarate (DMF), diroximel fumarate (DRF), and monomethyl fumarate (MMF), or fingolimod due to breakthrough disease activity.

Connect with a study center

  • Novartis Investigative Site

    Caba, Buenos Aires C1424BYD
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Rosario, Santa Fe S2000BZL
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Buenos Aires, C1424BYD
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Tucuman, 4000
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Liverpool, New South Wales 2170
    Australia

    Site Not Available

  • Novartis Investigative Site

    New Lambton Heights, New South Wales 2305
    Australia

    Site Not Available

  • Novartis Investigative Site

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Novartis Investigative Site

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Novartis Investigative Site

    Parkville, Victoria 3050
    Australia

    Site Not Available

  • Novartis Investigative Site

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Novartis Investigative Site

    Linz, 4020
    Austria

    Site Not Available

  • Novartis Investigative Site

    Vienna, 1090
    Austria

    Site Not Available

  • Novartis Investigative Site

    Wien, 1010
    Austria

    Site Not Available

  • Novartis Investigative Site

    Bonheiden, 2820
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Brugge, 8000
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Bruxelles, 1200
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Edegem, 2650
    Belgium

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  • Novartis Investigative Site

    Esneux, 4130
    Belgium

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  • Novartis Investigative Site

    Pleven, 5800
    Bulgaria

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  • Novartis Investigative Site

    Sofia, 1431
    Bulgaria

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  • Novartis Investigative Site

    Burnaby, British Columbia V5G 2X6
    Canada

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  • Novartis Investigative Site

    Toronto, Ontario M4N 3M5
    Canada

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  • Novartis Investigative Site

    Hradec Kralove, CZE 500 05
    Czechia

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  • Novartis Investigative Site

    Brno, 60200
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Havirov, 736 01
    Czechia

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  • Novartis Investigative Site

    Praha, 12808
    Czechia

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  • Novartis Investigative Site

    Teplice, 415 01
    Czechia

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    Tallinn, 11315
    Estonia

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    Tartu, 50406
    Estonia

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  • Novartis Investigative Site

    Regensburg, Bavaria 93053
    Germany

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    Cottbus, Brandenburg 03048
    Germany

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  • Novartis Investigative Site

    Osnabrueck, Niedersachsen 49076
    Germany

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  • Novartis Investigative Site

    Koeln, Nordrhein-Westfalen 50935
    Germany

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    Alzenau, 63755
    Germany

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    Berlin, 10713
    Germany

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    Bielefeld, 33647
    Germany

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    Erlangen, 91054
    Germany

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    Heidelberg, 69120
    Germany

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    Koln, 50935
    Germany

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    Leipzig, 04275
    Germany

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    Minden, 32429
    Germany

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    Muenchen, 81377
    Germany

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    Osnabrück, 49076
    Germany

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    Potsdam, 14471
    Germany

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    Siegen, 57076
    Germany

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    Ulm, 89081
    Germany

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    Unterhaching, 82008
    Germany

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    Westerstede Oldenburg, 26655
    Germany

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    Westerstede/Oldenburg, 26655
    Germany

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    Larissa, GR 411 10
    Greece

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    Amyntaio, 53246
    Greece

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    Greece, 53246
    Greece

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    Thessaloniki, GR 54636
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    Budapest, HUN 1135
    Hungary

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    Tatabanya, Komarom Esztergom 2800
    Hungary

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    Pecs, 7623
    Hungary

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    Firenze, FI 50134
    Italy

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    Pavia, PV 27100
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    Roma, RM 00152
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    Verona, VR 37134
    Italy

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    Riga, LV 1002
    Latvia

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    Ashrafieh, 166830
    Lebanon

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    Beirut, 8610
    Lebanon

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    Ciudad de Mexico, Distrito Federal 06700
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    Mexico, Distrito Federal 03100
    Mexico

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    Morelia, Michoacan 58260
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    Chihuahua, 31203
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    Bergen, 5021
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    Drammen, 1086
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    Oslo, NO-0407
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    Bydgoszcz, Woj Kujawsko-pomorskie 85-796
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    Katowice, 40 571
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    Kielce, 25 726
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    Lodz, 90-153
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    Wroclaw, 51-685
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    Braga, 4710243
    Portugal

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    Lisboa, 1349-019
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    Loures, 2674514
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    Porto, 4099-001
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    Moscow, 115516
    Russian Federation

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    St Petersburg, 190000
    Russian Federation

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    Riyadh, SAU 11525
    Saudi Arabia

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    Jeddah, 21499
    Saudi Arabia

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  • Novartis Investigative Site

    Banska Bystrica, 975 17
    Slovakia

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    Bratislava, 813 69
    Slovakia

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    Karachi, 75230
    Slovakia

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    Kosice, 041 90
    Slovakia

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    Nitra, 94901
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  • Novartis Investigative Site

    Trnava, 91702
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  • Novartis Investigative Site

    Ljubljana, 1000
    Slovenia

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    Maribor, 2000
    Slovenia

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  • Novartis Investigative Site

    Sevilla, Andalucia 41009
    Spain

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    Valencia, Comunidad Valenciana 46010
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  • Novartis Investigative Site

    El Palmar, Murcia 30120
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    Vigo, Pontevedra 36212
    Spain

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  • Novartis Investigative Site

    Baracaldo, Vizcaya 48903
    Spain

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    Barcelona, 08041
    Spain

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  • Novartis Investigative Site

    Madrid, 28040
    Spain

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  • Novartis Investigative Site

    Santa Cruz de Tenerife, 38009
    Spain

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  • Novartis Investigative Site

    Basel, 4031
    Switzerland

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  • Novartis Investigative Site

    Lugano, 6900
    Switzerland

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  • Novartis Investigative Site

    St Gallen, 9007
    Switzerland

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  • Novartis Investigative Site

    Sancaktepe, Istanbul 34785
    Turkey

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  • Novartis Investigative Site

    Istanbul, TUR 34098
    Turkey

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  • Novartis Investigative Site

    Izmir, 35100
    Turkey

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  • Novartis Investigative Site

    Samsun, 55139
    Turkey

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  • Novartis Investigative Site

    Trabzon, 61080
    Turkey

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  • Novartis Investigative Site

    Plymouth, Devon PL6 8BT
    United Kingdom

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    Cardiff, CF14 4XW
    United Kingdom

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    Swansea, SA2 8QA
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    Cullman, Alabama 35058
    United States

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    Tucson, Arizona 85718
    United States

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  • Fullerton Neuro and Headache Ctr

    Fullerton, California 92835
    United States

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  • Fullerton Neurology and Headache Center

    Fullerton, California 92835
    United States

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  • Novartis Investigative Site

    Fullerton, California 92835
    United States

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    Loma Linda, California 92354
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    Los Angeles, California 90033
    United States

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    Mountain View, California 94040
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    San Diego, California 92103
    United States

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  • CU Anschutz Med Campus

    Aurora, Colorado 80045
    United States

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  • Novartis Investigative Site

    Aurora, Colorado 80045
    United States

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  • Novartis Investigative Site

    Colorado Springs, Colorado 80907
    United States

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  • Christiana Care Health Services

    Newark, Delaware 19713
    United States

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  • Novartis Investigative Site

    Newark, Delaware 19713
    United States

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  • Memorial Hospital

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Novartis Investigative Site

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Homestead Assoc In Research Inc

    Homestead, Florida 33033
    United States

    Site Not Available

  • Neurology Associates PA

    Maitland, Florida 32751
    United States

    Site Not Available

  • Neurology Associates, PA

    Maitland, Florida 32751
    United States

    Site Not Available

  • Novartis Investigative Site

    Maitland, Florida 32751
    United States

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  • Homestead Associates in Research Inc

    Miami, Florida 33032
    United States

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  • Novartis Investigative Site

    Miami, Florida 33136
    United States

    Site Not Available

  • University of Miami Miller School of Medicine

    Miami, Florida 33136
    United States

    Site Not Available

  • Negroski Neurology

    Sarasota, Florida 34233
    United States

    Site Not Available

  • Novartis Investigative Site

    Sarasota, Florida 34233
    United States

    Site Not Available

  • Novartis Investigative Site

    Sunrise, Florida 33351
    United States

    Site Not Available

  • Axiom Clinical Research of Florida

    Tampa, Florida 33609
    United States

    Site Not Available

  • Novartis Investigative Site

    Tampa, Florida 33609
    United States

    Site Not Available

  • University Of South Florida

    Tampa, Florida 33612
    United States

    Site Not Available

  • University Of South Florida .

    Tampa, Florida 33612
    United States

    Site Not Available

  • Novartis Investigative Site

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Premiere Research Institute

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Atlanta Neuroscience Institute

    Atlanta, Georgia 30327
    United States

    Site Not Available

  • Novartis Investigative Site

    Atlanta, Georgia 30327
    United States

    Site Not Available

  • Georgia Neurology and Sleep Medicine Assoc

    Suwanee, Georgia 30024
    United States

    Site Not Available

  • Novartis Investigative Site

    Suwanee, Georgia 30024
    United States

    Site Not Available

  • Novartis Investigative Site

    Honolulu, Hawaii 96817
    United States

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  • Novartis Investigative Site

    Indianapolis, Indiana 46256
    United States

    Site Not Available

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Johns Hopkins Hospital Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Johns Hopkins MS Center

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Novartis Investigative Site

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Novartis Investigative Site

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Novartis Investigative Site

    Foxboro, Massachusetts 02035
    United States

    Site Not Available

  • Novartis Investigative Site

    Chesaning, Michigan 48616
    United States

    Site Not Available

  • Novartis Investigative Site

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Novartis Investigative Site

    Golden Valley, Minnesota 55422
    United States

    Site Not Available

  • Novartis Investigative Site

    Lincoln, Nebraska 68510
    United States

    Site Not Available

  • Novartis Investigative Site

    Omaha, Nebraska 68131
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Novartis Investigative Site

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Novartis Investigative Site

    Albuquerque, New Mexico 87131-0001
    United States

    Site Not Available

  • University of New Mexico

    Albuquerque, New Mexico 87131-0001
    United States

    Site Not Available

  • Novartis Investigative Site

    Amherst, New York 14226
    United States

    Site Not Available

  • Five Towns Neuroscience Research

    Woodmere, New York 11598
    United States

    Site Not Available

  • Novartis Investigative Site

    Woodmere, New York 11598
    United States

    Site Not Available

  • Novartis Investigative Site

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Cleveland Clinic Foundation .

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Novartis Investigative Site

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Columbus Neuroscience

    Westerville, Ohio 43082
    United States

    Site Not Available

  • Novartis Investigative Site

    Westerville, Ohio 43082
    United States

    Site Not Available

  • Multiple Sclerosis Center of Excellence of OMRF

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Novartis Investigative Site

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Novartis Investigative Site

    Portland, Oregon 97225
    United States

    Site Not Available

  • Novartis Investigative Site

    Philadelphia, Pennsylvania 19107-5098
    United States

    Site Not Available

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107-5098
    United States

    Site Not Available

  • Novartis Investigative Site

    Pittsburgh, Pennsylvania 15240
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Novartis Investigative Site

    Houston, Texas 77030
    United States

    Site Not Available

  • North TX Inst of Neuro and Headache

    Plano, Texas 75024
    United States

    Site Not Available

  • Novartis Investigative Site

    Plano, Texas 75024
    United States

    Site Not Available

  • INOVA Medical Group

    Fairfax, Virginia 22030
    United States

    Site Not Available

  • INOVA Medical Group .

    Fairfax, Virginia 22030
    United States

    Site Not Available

  • Novartis Investigative Site

    Fairfax, Virginia 22030
    United States

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  • Ascension St Francis Center

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

  • Novartis Investigative Site

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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