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NCT03650114Active, not recruitingPhase 3

Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS

An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis

Source: ClinicalTrials.gov · Last updated 27 May 2026

Brief summary (registry, in English)

The purpose of this study is to collect long-term safety, tolerability, effectiveness and health outcomes data in eligible subjects who have participated in a Novartis ofatumumab clinical MS study. Vaccination sub-study The purpose of this research sub-study is to find out the effects of ofatumumab on the development of antibody responses to selected vaccines and keyhole limpet hemocyanin (KLH) neo-antigen in subjects with relapsing multiple sclerosis (RMS). COVID-19 sub-study: The purpose of this research sub-study is to explore the immune response following Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccination in a subset of subjects on long-term ofatumumab 20 mg sc. Note: Novartis is not supplying the SARS-CoV-2 vaccine.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1882 (actual)
First submitted
17 Aug 2018
Start date
28 Dec 2018
Primary completion date
30 Sept 2028
Lead sponsor
Novartis Pharmaceuticals
NCT number
NCT03650114
EudraCT number
2023-507906-15

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 1882
  • From 28 Dec 2018 to the primary completion date, 30 Sept 2028
  • 259 sites in 37 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Emergence of any clinically significant condition/disease during the previous ofatumumab study in which study participation might result in safety risk for the subject
  • Subjects taking medications prohibited by the protocol
  • any safety findings including low IgG/IgM requiring ofatumumab interruption within 12 weeks prior to vaccination sub-study start
  • any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks of the first vaccination sub-study visit
    • Other protocol-defined inclusion/exclusion criteria may apply

Other illness

  • Subjects with active systemic bacterial, viral or fingal infections, or chronic infection (e.g. AIDS)
  • known hypersensitivity or history of systemic allergic, neurologic or other reactions to vaccines
  • allergies to egg or shellfish

Other

  • Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply
    • Vaccination sub-study:

Who the study is looking for

  • Must have completed a selected Novartis MS study which dosed ofatumumab 20 mg sc every 4 weeks
  • Written informed consent
  • Informed consent
  • Actively enrolled in the COMB157G2399 Study
  • 12 weeks of continuous treatment within the COMB157G2399 Study
  • prior vaccination history as per protocol-defined

Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (259)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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Buenos AiresArgentinaUnknown status
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CórdobaArgentinaUnknown status
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RosarioArgentinaUnknown status
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San Miguel de TucumánArgentinaUnknown status
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ViennaAustriaUnknown status
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LiverpoolAustraliaUnknown status
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New Lambton HeightsAustraliaUnknown status
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St LeonardsAustraliaUnknown status
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BrasschaatBelgiumUnknown status
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BrugesBelgiumUnknown status
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BrusselsBelgiumUnknown status
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EdegemBelgiumUnknown status
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GhentBelgiumUnknown status
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PlevenBulgariaUnknown status
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SofiaBulgariaUnknown status
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GatineauCanadaUnknown status
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Greenfield ParkCanadaUnknown status
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LondonCanadaUnknown status
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MontrealCanadaUnknown status
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OttawaCanadaUnknown status
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QuébecCanadaUnknown status
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TorontoCanadaUnknown status
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BaselSwitzerlandUnknown status
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LuganoSwitzerlandUnknown status
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BrnoCzechiaUnknown status
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HavířovCzechiaUnknown status
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Hradec KrálovéCzechiaUnknown status
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JihlavaCzechiaUnknown status
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OlomoucCzechiaUnknown status
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PardubiceCzechiaUnknown status
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PragueCzechiaUnknown status
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TepliceCzechiaUnknown status
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BarsinghausenGermanyUnknown status
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BayreuthGermanyUnknown status
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BielefeldGermanyUnknown status
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BochumGermanyUnknown status
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CologneGermanyUnknown status
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DresdenGermanyUnknown status
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EssenGermanyUnknown status
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HamburgGermanyUnknown status
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HanoverGermanyUnknown status
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HeidelbergGermanyUnknown status
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LeipzigGermanyUnknown status
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MarburgGermanyUnknown status
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MindenGermanyUnknown status
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MünchenGermanyUnknown status
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MunichGermanyUnknown status
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Neuburg A.d. DonauGermanyUnknown status
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PotsdamGermanyUnknown status
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SiegenGermanyUnknown status
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UlmGermanyUnknown status
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UnterhachingGermanyUnknown status
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Glostrup MunicipalityDenmarkUnknown status
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Odense CDenmarkUnknown status
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TallinnEstoniaUnknown status
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TartuEstoniaUnknown status
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BarakaldoSpainUnknown status
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BarcelonaSpainUnknown status
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CadizSpainUnknown status
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Castilleja de la CuestaSpainUnknown status
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Donostia / San SebastianSpainUnknown status
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El PalmarSpainUnknown status
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L'Hospitalet de LlobregatSpainUnknown status
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MadridSpainUnknown status
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MajadahondaSpainUnknown status
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MálagaSpainUnknown status
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Pozuelo de AlarcónSpainUnknown status
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SaltSpainUnknown status
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SevilleSpainUnknown status
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ValenciaSpainUnknown status
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TampereFinlandUnknown status
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TurkuFinlandUnknown status
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LilleFranceUnknown status
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MontpellierFranceUnknown status
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NantesFranceUnknown status
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NiceFranceUnknown status
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NîmesFranceUnknown status
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ParisFranceUnknown status
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StrasbourgFranceUnknown status
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GlasgowUnited KingdomUnknown status
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LondonUnited KingdomUnknown status
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LutonUnited KingdomUnknown status
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OxfordUnited KingdomUnknown status
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SheffieldUnited KingdomUnknown status
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AthensGreeceUnknown status
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ThessalonikiGreeceUnknown status
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OsijekCroatiaUnknown status
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RijekaCroatiaUnknown status
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ZagrebCroatiaUnknown status
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BudapestHungaryUnknown status
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KistarcsaHungaryUnknown status
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PécsHungaryUnknown status
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SzegedHungaryUnknown status
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AshkelonIsraelUnknown status
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HaifaIsraelUnknown status
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SefadIsraelUnknown status
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Tel AvivIsraelUnknown status
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ChandigarhIndiaUnknown status
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HowrahIndiaUnknown status
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HyderabadIndiaUnknown status
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KochiIndiaUnknown status
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MangaloreIndiaUnknown status
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MumbaiIndiaUnknown status
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New DelhiIndiaUnknown status
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PuneIndiaUnknown status
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ChibaJapanUnknown status
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KawagoeJapanUnknown status
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KodairaJapanUnknown status
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NiigataJapanUnknown status
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OsakaJapanUnknown status
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SapporoJapanUnknown status
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SendaiJapanUnknown status
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Shinjuku KuJapanUnknown status
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Shiwa-GunJapanUnknown status
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TōonJapanUnknown status
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KaunasLithuaniaUnknown status
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VilniusLithuaniaUnknown status
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RigaLatviaUnknown status
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Chihuahua CityMexicoUnknown status
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Mexico CityMexicoUnknown status
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AmsterdamNetherlandsUnknown status
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RotterdamNetherlandsUnknown status
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Sittard-GeleenNetherlandsUnknown status
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DrammenNorwayUnknown status
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LimaPeruUnknown status
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Lima CercadoPeruUnknown status
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San IsidroPeruUnknown status
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BydgoszczPolandUnknown status
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GdanskPolandUnknown status
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Glogow WielkopolskiPolandUnknown status
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KatowicePolandUnknown status
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KielcePolandUnknown status
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LodzPolandUnknown status
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PoznanPolandUnknown status
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RzeszówPolandUnknown status
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WarsawPolandUnknown status
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WroclawPolandUnknown status
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ZabrzePolandUnknown status
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BragaPortugalUnknown status
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CoimbraPortugalUnknown status
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LisbonPortugalUnknown status
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LouresPortugalUnknown status
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Matosinhos MunicipalityPortugalUnknown status
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PortoPortugalUnknown status
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Santa Maria da FeiraPortugalUnknown status
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Kazan'RussiaUnknown status
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KemerovoRussiaUnknown status
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KrasnoyarskRussiaUnknown status
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MoscowRussiaUnknown status
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Nizhny NovgorodRussiaUnknown status
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NovosibirskRussiaUnknown status
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Saint PetersburgRussiaUnknown status
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SaranskRussiaUnknown status
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SestroretskRussiaUnknown status
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TyumenRussiaUnknown status
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YekaterinburgRussiaUnknown status
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GothenburgSwedenUnknown status
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StockholmSwedenUnknown status
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Banská BystricaSlovakiaUnknown status
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BratislavaSlovakiaUnknown status
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MartinSlovakiaUnknown status
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NitraSlovakiaUnknown status
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TrnavaSlovakiaUnknown status
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Khon KaenThailandUnknown status
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TainanTaiwanUnknown status
Neurology and Neuroscience Assos
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AkronUnited StatesUnknown status
University of New Mexico
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AlbuquerqueUnited StatesUnknown status
Neuro Medical Clinic of Cenla LLC
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AlexandriaUnited StatesUnknown status
Asheville Neurology Specialists PA
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AshevilleUnited StatesUnknown status
JEM Research Institute
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AtlantisUnited StatesUnknown status
CU Anschutz Med Campus
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AuroraUnited StatesUnknown status
Mountain Neuro Research Center PC
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BasaltUnited StatesUnknown status
The NeuroMedical Center
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Baton RougeUnited StatesUnknown status
Billings Clinic
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BillingsUnited StatesUnknown status
University of Alabama at Birmingham
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BirminghamUnited StatesUnknown status
Alpine Clinical Research Center
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BoulderUnited StatesUnknown status
The Neurological Institute PA
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CharlotteUnited StatesUnknown status
Rush University Medical Center
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ChicagoUnited StatesUnknown status
Cleveland Clinic Foundation
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ClevelandUnited StatesUnknown status
Colorado Springs Neurological Associates
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Colorado SpringsUnited StatesUnknown status
Ohio Health Research Institute
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ColumbusUnited StatesUnknown status
Wesley Neurology Clinic
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CordovaUnited StatesUnknown status
North Central Neurology Associates PC
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CullmanUnited StatesUnknown status
Neurology Offices of South Florida PLLC
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Delray BeachUnited StatesUnknown status
Colorado Neurological Research PC
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DenverUnited StatesUnknown status
Henry Ford Hospital
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DetroitUnited StatesUnknown status
Wayne State University Multiple Sclerosis Clinic
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DetroitUnited StatesUnknown status
Med Research Inc
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El PasoUnited StatesUnknown status
University of Colorado Health Neurology
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Fort CollinsUnited StatesUnknown status
Fullerton Neuro and Headache Ctr
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FullertonUnited StatesUnknown status
Advanced Neurology Specialists
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Great FallsUnited StatesUnknown status
Aurora BayCare Medical Center
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Green BayUnited StatesUnknown status
Guilford Neurologic Associate Research
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GreensboroUnited StatesUnknown status
Premier Neurology
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GreenvilleUnited StatesUnknown status
Infinity Clinical Research, LLC
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HollywoodUnited StatesUnknown status
Homestead Assoc In Research Inc
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HomesteadUnited StatesUnknown status
Hawaii Pacific Neuroscience LLC
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HonoluluUnited StatesUnknown status
Josephson Wallack Munshower Neurology, PC
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IndianapolisUnited StatesUnknown status
Tri State Mountain Neurology
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JohnsonUnited StatesUnknown status
University of Kansas Hospital
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Kansas CityUnited StatesUnknown status
Evergreen Health Multiple Sclerosis Center
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KirklandUnited StatesUnknown status
Sibyl Wray MD Neurology PC
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KnoxvilleUnited StatesUnknown status
University of Tennessee Medical Ctr
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KnoxvilleUnited StatesUnknown status
Cleveland Clinic Foundation
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Las VegasUnited StatesUnknown status
Ms Ctr Of Northeastern Ny
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LathamUnited StatesUnknown status
Neurology and Sleep Center
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LubbockUnited StatesUnknown status
University of Wisconsin - Madison
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MadisonUnited StatesUnknown status
Neurology Associates PA
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MaitlandUnited StatesUnknown status
UM Department Of Neurology
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MiamiUnited StatesUnknown status
Ascension St Francis Center
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MilwaukeeUnited StatesUnknown status
St Luke s Medical Center Aurora
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MilwaukeeUnited StatesUnknown status
Aqualane Clinical Research
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NaplesUnited StatesUnknown status
Christiana Care Health Services
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NewarkUnited StatesUnknown status
Consultants in Neurology
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NorthbrookUnited StatesUnknown status
Multiple Sclerosis Center of Excellence of OMRF
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Oklahoma CityUnited StatesUnknown status
MS and Neuromuscular Center of Excellence
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OldsmarUnited StatesUnknown status
Neurology Associates of Ormond Beach
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Ormond BeachUnited StatesUnknown status
College Park Family Care Center
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Overland ParkUnited StatesUnknown status
Sharlin Health and Neurology
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OzarkUnited StatesUnknown status
Emerald Coast Neurology
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PensacolaUnited StatesUnknown status
Thomas Jefferson University Hospital
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PhiladelphiaUnited StatesUnknown status
Barrow Neurological Clinics at St Josephs Hospital and MC
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PhoenixUnited StatesUnknown status
Vivo Infusion
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PlymouthUnited StatesUnknown status
Neurostudies Inc.
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Port CharlotteUnited StatesUnknown status
Providence Neurological Services West
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PortlandUnited StatesUnknown status
Velocity Clinical Research
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RaleighUnited StatesUnknown status
Central TX Neuro Consultants P A
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Round RockUnited StatesUnknown status
University of California - Davis
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SacramentoUnited StatesUnknown status
The University of Utah
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Salt Lake CityUnited StatesUnknown status
Rocky Mountain MS Clinic
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Salt Lake CityUnited StatesUnknown status
Lonestar Neurology of San Antonio
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San AntonioUnited StatesUnknown status
Roskamp Institute Inc
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SarasotaUnited StatesUnknown status
Negroski Neurology
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SarasotaUnited StatesUnknown status
Velocity Clinical Research
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SavannahUnited StatesUnknown status
Texas Institute for Neurological Disorders
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ShermanUnited StatesUnknown status
BG Neurology
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SpartanburgUnited StatesUnknown status
Upstate Clinical Trials LLC
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SpartanburgUnited StatesUnknown status
Mercy Research
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St LouisUnited StatesUnknown status
WA Uni School Of Med
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St LouisUnited StatesUnknown status
Georgia Neurology and Sleep Medicine Assoc
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SuwaneeUnited StatesUnknown status
MultiCare Research Institute for Research and Innovation
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TacomaUnited StatesUnknown status
AMO Corporation
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TallahasseeUnited StatesUnknown status
Axiom Clinical Research of Florida
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TampaUnited StatesUnknown status
Clinical Research of West Florida Inc
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TampaUnited StatesUnknown status
University of South Florida
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TampaUnited StatesUnknown status
Sentara Neuroscience Institute
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Virginia BeachUnited StatesUnknown status
Dragonfly Research LLC
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Wellesley HillsUnited StatesUnknown status
Columbus Neuroscience
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WestervilleUnited StatesUnknown status
Premiere Research Institute
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West Palm BeachUnited StatesUnknown status
Abington Neurological Associates Ltd
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Willow GroveUnited StatesUnknown status
PMG Research of Winston Salem
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Winston-SalemUnited StatesUnknown status
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PretoriaSouth AfricaUnknown status
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RosebankSouth AfricaUnknown status
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IstanbulTurkey (Türkiye)Unknown status
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IzmirTurkey (Türkiye)Unknown status
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KocaeliTurkey (Türkiye)Unknown status
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MersinTurkey (Türkiye)Unknown status
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SamsunTurkey (Türkiye)Unknown status
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TrabzonTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.