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NCT05327114RecruitingPhase 2/3

Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Phase 2/3, Multistage, Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel Group Withdrawal Study to Evaluate the Efficacy and Safety of Nipocalimab Administered to Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

The main purpose of this study is to evaluate the safety and efficacy of nipocalimab compared to placebo in delaying relapse in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) who initially respond to nipocalimab in Stage A.

Status (registry)
Recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
201 (estimated)
First submitted
7 Apr 2022
Start date
23 Sept 2022
Primary completion date
15 Dec 2026
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT05327114
EU CT number
2023-508425-28-00
EudraCT number
2021-003234-37

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 201
  • From 23 Sept 2022 to the primary completion date, 15 Dec 2026
  • 119 sites in 19 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

  • Polyneuropathy of other causes, including the following: Multifocal motor neuropathy (MMN); Monoclonal gammopathy of uncertain significance with antimyelin associated glycoprotein (anti-MAG) immunoglobulin M (IgM) antibodies; Hereditary motor neuropathy; Hereditary neuropathy with liability to pressure palsies (HNPP); Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes; Lumbosacral radiculoplexus neuropathy; Polyneuropathy most likely due to diabetes mellitus; Polyneuropathy most likely due to systemic illnesses; Drug- or toxin-induced polyneuropathy Note: A concomitant polyneuropathy of other causes (example, a mild, stable diabetic polyneuropathy) is not necessarily exclusionary if chronic inflammatory demyelinating polyneuropathy (CIDP) is confirmed as the main diagnosis, as determined by the investigator and confirmed by the adjudication committee

Other illness

  • Any other disease that could better explain the participant's signs and symptoms, such as significant persisting neurological deficits from stroke or central nervous system (CNS) trauma or peripheral neuropathy from another cause such as connective tissue disease or systemic lupus erythematosus
  • Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients

Lab values

  • Has a history of severe and/or uncontrolled hepatic (example, viral/alcoholic/autoimmune hepatitis/cirrhosis and/or metabolic liver disease), gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension and/or any other medical or uncontrolled autoimmune disorder(s) (example, diabetes mellitus) or clinically significant abnormalities in screening laboratory that, might interfere with the participants full participation in the study, or might jeopardize the safety of the participant or the validity of the study results

Other

  • Pure sensory CIDP or chronic immune sensory polyradiculopathy (CISP) (EAN/PNS definition)
  • Other protocol-defined exclusion criteria will apply

Who the study is looking for

  • Adults greater than or equal to (\>=) 18 years of age at the time of consent and as applicable, must also meet the legal age of consent in the jurisdiction in which the study is taking place
  • Diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) according to criteria of the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) 2021, progressing or relapsing forms. CIDP diagnosis to be adjudicated by independent committee during screening period
  • Inflammatory Neuropathy Cause and Treatment (INCAT) disability score between 2 and 9 at the Run-In Baseline visit for participants entering Run-In, or Stage A Baseline visit for participants directly entering Stage A. Participants with an INCAT score of 2 at trial entry must have this score exclusively from the leg disability score
  • Fulfilling any of the following treatment conditions: a) Currently treated with oral corticosteroids (CS) less than or equal to (\<=) 20 milligrams (mg)/day; or b) Currently treated with pulsed CS, and/or intravenous immunoglobulin (IVIg) or subcutaneous immunoglobulin (SCIg) and the participant is willing to discontinue no later than the run-in baseline visit; or c) Currently treated with oral CS greater than (\>) 20 mg/day and the participant is willing to taper to \<=20 mg/day during the run-in period; or d) Without previous treatment (treatment naive); or treatment with CS and/or IVIg or SCIg discontinued at least 3 months prior to screening (untreated)
  • Active disease as determined by CIDP Disease Activity Status (CDAS) score \>= 3
  • Other protocol-defined inclusion criteria will apply

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

Full criteria on ClinicalTrials.gov

Sites (119)

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

SiteCityCountrySite status
Instituto Fleni
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Buenos AiresArgentinaRecruiting
Hospital Italiano de Buenos Aires
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Buenos AiresArgentinaActive, not recruiting
Hospital Gral Agudos Ignacio Pirovano
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Buenos AiresArgentinaCompleted
INECO Neurociencias Oroño
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RosarioArgentinaRecruiting
The Alfred Hospital
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MelbourneAustraliaCompleted
Gold Coast University Hospital
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ParkwoodAustraliaCompleted
The Ottawa Hospital Ottawa NeuroMuscular Centre
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OttawaCanadaRecruiting
Beijing Tiantan Hospital,Capital Medical University
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BeijingChinaActive, not recruiting
Peking University Third Hospital
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BeijingChinaCompleted
Peking University First Hospital
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BeijingChinaCompleted
Xuanwu Hospital, Capital Medical University
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BeijingChinaActive, not recruiting
The First Hospital of Jilin University
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ChangchunChinaActive, not recruiting
Xiangya Hospital Central South University
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ChangshaChinaCompleted
The Third Xiangya Hospital of Central Sourth University
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ChangshaChinaActive, not recruiting
Sichuan Provincial Peoples Hospital
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ChengduChinaCompleted
Chifeng Municipal Hospital
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ChifengChinaCompleted
Fujian Medical University Union Hospital
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FuzhouChinaActive, not recruiting
The First Affiliated Hospital, Sun Yat-sen University
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GuangzhouChinaActive, not recruiting
Qianfoshan Hospital of Shandong Province
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JinanChinaCompleted
Qilu Hospital of Shandong University
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JinanChinaActive, not recruiting
The First Affiliated Hospital of NanChang University
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NanchangChinaActive, not recruiting
Huashan Hospital, Fudan University
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ShanghaiChinaActive, not recruiting
Tong Ren Hospital,Shanghai Jiao Tong University School Of Medicine
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ShanghaiChinaCompleted
Renmin Hospital of Wuhan University
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WuhanChinaCompleted
Tangdu hospital the Fourth Military Medical
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Xi'anChinaCompleted
Xi'an Gaoxin Hospital
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Xi’anChinaActive, not recruiting
Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca
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FloridablancaColombiaCompleted
Instituto Neurológico de Colombia
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MedellínColombiaActive, not recruiting
Fakultni Nemocnice Hradec Kralove
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Novy Hradec KraloveCzechiaActive, not recruiting
Juedisches Krankenhaus Berlin Stiftung Des Buergerlichen Rechts
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BerlinGermanyActive, not recruiting
Katholisches Klinikum Bochum gGmbH
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BochumGermanyActive, not recruiting
Universitaetsmedizin Goettingen
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GoettingenGermanyActive, not recruiting
Martha-Maria Krankenhaus Halle-Doelau gGmbH
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Halle (saale)GermanyActive, not recruiting
Medizinische Hochschule Hannover
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HanoverGermanyActive, not recruiting
Universitaetsklinikum Leipzig Aor
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LeipzigGermanyActive, not recruiting
Medizinische Versorgungszentren St. Josefs-Krankenhaus Potsdam GmbH
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PotsdamGermanyActive, not recruiting
Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V.
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UlmGermanyActive, not recruiting
Hospital General Universitario Dr. Balmis
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AlicanteSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital Universitario Basurto
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BilbaoSpainActive, not recruiting
Hospital Universitario Donostia
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DonostiaSpainActive, not recruiting
Hospital Clínico San Carlos
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MadridSpainActive, not recruiting
Hospital Universitario Virgen De La Macarena
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SevillaSpainActive, not recruiting
Centre hospitalier Universitaire de Bordeaux
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BordeauxFranceActive, not recruiting
Hospital Pierre Wertheimer
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BronFranceActive, not recruiting
Assistance Publique Hopitaux De Paris
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Le Kremlin-BicetreFranceActive, not recruiting
Centre Hospitalier Regional De Marseille
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MarseilleFranceActive, not recruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceActive, not recruiting
Centre Hospitalier Universitaire De Nimes
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Nimes Cedex 9FranceActive, not recruiting
Fondation A. de Rothschild
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ParisFranceActive, not recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceActive, not recruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg Cedex 2FranceActive, not recruiting
University Hospitals Birmingham NHS Foundation Trust
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BirminghamUnited KingdomCompleted
Royal Devon & Exeter Hospital
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DevonUnited KingdomCompleted
NHS Greater Glasgow and Clyde
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GlasgowUnited KingdomActive, not recruiting
Royal Free Hospital
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LondonUnited KingdomCompleted
Sheffield Teaching Hospitals NHS Foundation Trust
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SheffieldUnited KingdomActive, not recruiting
University General Hospital Attikon
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AthensGreeceActive, not recruiting
General Hospital Of Thessaloniki Papageorgiou
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EfkarpiaGreeceActive, not recruiting
University General Hospital of Thessaloniki - AHEPA
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ThessalonikiGreeceActive, not recruiting
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
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CataniaItalyActive, not recruiting
IRCCS Ospedale Policlinico San Martino
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GenoaItalyActive, not recruiting
Casa Di Cura Igea S.p.A.
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MilanItalyActive, not recruiting
IRCCS Foundation Istituto Neurologico Carlo Besta
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MilanItalyActive, not recruiting
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli
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NaplesItalyActive, not recruiting
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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OrbassanoItalyActive, not recruiting
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
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PaviaItalyActive, not recruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyActive, not recruiting
Azienda Ospedaliera Policlinico Universitario Tor Vergata
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RomeItalyActive, not recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyActive, not recruiting
Humanitas Mirasole S.p.A.
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RozzanoItalyActive, not recruiting
National Hospital Organization Asahikawa Medical Center
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AsahikawaJapanActive, not recruiting
Institute of Science Tokyo Hospital
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Bunkyō CityJapanActive, not recruiting
Chiba University Hospital
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ChibaJapanCompleted
Seirei Hamamatsu General Hospital
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HamamatsuJapanActive, not recruiting
Tokai University Hospital
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IseharaJapanActive, not recruiting
Kobe City Medical Center General Hospital
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KobeJapanCompleted
National Center of Neurology and Psychiatry
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Kodaira-shiJapanActive, not recruiting
Saitama Medical Center
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KoshigayaJapanActive, not recruiting
Kumamoto University Hospital
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KumamotoJapanCompleted
Chubu Rosai Hospital
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NagoyaJapanActive, not recruiting
Nagoya University Hospital
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NagoyaJapanActive, not recruiting
Kindai University Hospital
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Osaka Sayama ShiJapanCompleted
National Hospital Organization Sendai Medical Center
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SendaiJapanActive, not recruiting
Dokkyo Medical University Hospital
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Shimotsuga-gunJapanCompleted
Tokyo Women's Medical University Hospital
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Shinjuku-kuJapanCompleted
Tenri Hospital
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TenriJapanCompleted
Ehime University Hospital
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Toon-shiJapanCompleted
Toyama University Hospital
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ToyamaJapanCompleted
Yamaguchi University Hospital
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UbeJapanCompleted
Samsung Medical Center
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SeoulSouth KoreaCompleted
KyungHee University Medical Center
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SeoulSouth KoreaCompleted
Konkuk University Medical Center
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SeoulSouth KoreaCompleted
i Can Oncology Center
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MonterreyMexicoCompleted
Clinical Research Institute S.C.
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TlalnepantlaMexicoRecruiting
Clinirem Sp. z o.o.
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LublinPolandActive, not recruiting
Clinical Research Center Sp z o o Medic R Sp k
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PoznanPolandActive, not recruiting
Unidade Local De Saude De Almada-Seixal E.P.E.
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AlmadaPortugalActive, not recruiting
CCAB Centro Clinico Academico Braga Associacao
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BragaPortugalActive, not recruiting
Centro Hospitalar Universitario Sao Joao E.P.E.
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PortoPortugalActive, not recruiting
Kaohsiung Chang Gung Memorial Hospital
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Kaohsiung CityTaiwanCompleted
National Taiwan University Hospital
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TaipeiTaiwanActive, not recruiting
Shin Kong Wu Ho Su Memorial Hospital
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TaipeiTaiwanActive, not recruiting
Augusta University
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AugustaUnited StatesCompleted
Austin Neuromuscular Center
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AustinUnited StatesCompleted
Johns Hopkins Hospital
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BaltimoreUnited StatesCompleted
Boston Clinical Trials
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BostonUnited StatesCompleted
IMMUNOe Health and Research Centers
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CentennialUnited StatesActive, not recruiting
The Neurological Institute PA
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CharlotteUnited StatesCompleted
Cleveland Clinic - Main Campus
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ClevelandUnited StatesActive, not recruiting
Healthcare Innovations Institute Inc
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Coral SpringsUnited StatesCompleted
Kansas City Veterans Affairs Medical Center
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Kansas CityUnited StatesCompleted
University of Kansas Medical Center
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Kansas CityUnited StatesCompleted
Neurology Associates PA
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MaitlandUnited StatesCompleted
ALS Center at the University of Miami
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MiamiUnited StatesActive, not recruiting
Advocate Health - Aurora St. Luke's Medical Center
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MilwaukeeUnited StatesActive, not recruiting
The Neurological Institute of New York
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New YorkUnited StatesCompleted
South Shore Neurologic Associates - Patchogue
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PatchogueUnited StatesCompleted
Beaumont Hospital, Royal Oak
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Royal OakUnited StatesCompleted

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