Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad)
Start Date
6/25/2024
Completion Date
11/12/2030
Summary
The purpose of this clinical study is to determine the efficacy and safety of a new oral cladribine formulation in participants with Generalized Myasthenia Gravis (gMG) in comparison to placebo. It will also investigate the sustained efficacy, the need for retreatment, and the long-term safety of oral cladribine in gMG. An additional component is included to characterize the Pharmacokinetics (PK) of the new cladribine formulation in gMG participants. This study is divided into 3 periods: the double-blind placebo control (DBPC) pivotal period, and 2 extensions, the blinded extension (BE) and the retreatment (RT) period. Furthermore, in trial interviews will be conducted as a sub-study to MyClad with a sub-set of participants to gain an in depth understanding of the participant cladribine treatment and study experience.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Placebo
Cladribine Low Dose
Cladribine High Dose
Conditions
Locations
Arizona Neuroscience Research, LLC
Phoenix, Arizona 85032
United States
Advanced Neurosciences Research LLC
Longmont, Colorado 80501
United States
University of Connecticut Health Center - Department of Medicine
Farmington, Connecticut 06030-5550
United States
The George Washington University Medical Faculty Associates Foggy Bottom South Pavilion
Washington D.C., District of Columbia 20037
United States
Neurology of Central Florida Research Center, LLC
Altamonte Springs, Florida 32714
United States
SFM Clinical Research, LLC
Boca Raton, Florida 33487
United States
University of Florida Health Science Center - 300120311
Jacksonville, Florida 32209
United States
Neurology Associates, P. A.
Maitland, Florida 32751
United States
University of South Florida - PARENT - PARENT
Tampa, Florida 33612
United States
University of Kansas Medical Center Research Institute, Inc. - 3901 Rainbow (MAIN)
Kansas City, Kansas 66160
United States
UNC Hospitals - PARENT
Chapel Hill, North Carolina 27599
United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina 27157-1078
United States
Miami Valley Hospital South
Centerville, Ohio 45459
United States
University of Cincinnati
Cincinnati, Ohio 45219
United States
Clinical Trials of South Carolina - Charleston
Charleston, South Carolina 29406
United States
Erlanger Health, Inc. - 1123255
Chattanooga, Tennessee 37403
United States
Baylor Scott & White Research Institute - Baylor Scott & White Research Institute
Dallas, Texas 75246
United States
ANESC Research
El Paso, Texas 79912
United States
Baylor Scott & White Neurology - McKinney
McKinney, Texas 75071
United States
The University of Vermont Medical Center
Burlington, Vermont 05401
United States
Integrated Neurology Services - Dr. Simon Fishman's Office
Falls Church, Virginia 22043
United States
Expertia S.A- Mautalen Salud e Investigación
Ciudad Autonoma Buenos Aires, 1427
Argentina
Instituto de Investigaciones Neurologicas Raul Carrea, FLENI - de Investigaciones Clinicas del área de Cardiología y enfermedades metabólicas asociadas
Ciudad Autonoma Buenos Aires, 1428
Argentina
Instituto de Investigaciones Metabolicas (IDIM)
Ciudad Autonoma Buenos Aires, C1012AAR
Argentina
Hospital Cordoba
Córdoba,
Argentina
Fundacion Rosarina de Neurorehabilitacion
Rosario,
Argentina
INECO Neurociencias Oroño
Rosario,
Argentina
CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
San Juan, 5400
Argentina
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán,
Argentina
Brain and Mind Research Institute
Camperdown, New South Wales 2050
Australia
Sunshine Coast University Hospital
Birtinya, Queensland 4575
Australia
Princess Alexandra Hospital - PARENT
South Brisbane, Queensland 4101
Australia
John Hunter Hospital - PARENT
City of Burnside, South Australia SA 5072
Australia
Box Hill Hospital - PARENT
Box Hill, Victoria 3128
Australia
Gold Coast University Hospital - PARENT
Southport,
Australia
UZ Leuven
Leuven, 3000
Belgium
C. H. R. de la Citadelle - Account 1
Liège, 4000
Belgium
Medical Center Hera - branch Montana
Montana, 3400
Bulgaria
UMHAT 'Dr. Georgi Stranski', EAD
Pleven, 5800
Bulgaria
UMHAT "Sv. Georgi", EAD
Plovdiv, 4000
Bulgaria
MHATNP "Sv.Naum", EAD - Third Neurology Clinic
Sofia, 1113
Bulgaria
UMHATEM 'N.I. Pirogov', EAD
Sofia, 1606
Bulgaria
Burnaby Hospital - Fraser Health Multiple Sclerosis Clinic
Burnaby, British Columbia V5G 2X6
Canada
The First Affiliated Hospital of Bengbu Medical College
Anhui Sheng, Anhui 233000
China
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality 100053
China
Peking Union Medical College Hospital
Beijing, Beijing Municipality 100730
China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine - 300164595
Guangzhou, Guangdong 510405
China
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou 563099
China
Shijiazhuang People's Hospital
Shijiazhuang, Hebei 050000
China
Henan Provincial People's Hospital
Zhengzhou, Henan 450003
China
Xiangya Hospital, Central South University
Changsha, Hu'nan 410008
China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei 430030
China
The First Hospital of Jilin University - The First Hospital of Jilin University
Changchun, Jilin 130021
China
China-Japan Union Hospital of Jilin University - 300173736
Changchun, Jilin 130033
China
Shengjing Hospital of China Medical University
Shenyang, Liaoning 110004
China
Huashan Hospital, Fudan University - Neurology
Shanghai, Shanghai Municipality 200040
China
Xi 'an International Medical Center
Xi’an, Shanxi 710038
China
West China Hospital, Sichuan University
Chengdu, Sichuan 610041
China
CHU Nice - Hôpital Pasteur - Cardiology
Nice, Alpes Maritimes 06002
France
CHU Strasbourg - Hopital Hautepierre - Service Anesthesie-Reanimation&Medecine Peri-Opera
Strasbourg, Bas Rhin 67098
France
CHU de Grenoble - Hôpital Albert Michallon - Centre de Références des Maladies Neuromusculaires
La Tronche, Isere 38700
France
Fondation Ophtalmologique Adolphe de Rothschild - Service de neurologie
Paris, Paris 75940
France
CHU Clermont Ferrand - Hopital Gabriel Montpied - service de neurologie B
Clermont-Ferrand, Puy De Dome 63003
France
Hopital Neurologique Pierre Wertheimer - Pathologies neuro-musculaires. Electromyographie
Bron, Rhone 69677
France
Hôpital Henri Mondor - Service de Neurologie
Créteil, Val De Marne 94010
France
Groupe Hospitalier Pitie-Salpetriere - Centre Référent Maladies Rares SLA - Neurologie
Paris, 75013
France
Ltd. Pineo Medical Ecosystem
Tbilisi, 0114
Georgia
New Hospitals LLC
Tbilisi, 0114
Georgia
Aversi Clinic Ltd
Tbilisi, 0160
Georgia
Universitaetsklinikum Ulm - Klinik fuer Neurologie
Ulm, Baden-Wurttemberg 89081
Germany
Universitaetsmedizin Goettingen - Abteilung fuer Nephrologie und Rheumatologie
Göttingen, Lower Saxony 37075
Germany
Medizinische Hochschule Hannover - Klinik fur Neurologie mit Klinischer Neurophysiol
Hanover, Lower Saxony 30625
Germany
St. Joseph Hospital - St. Joseph Hospital Haan
Bochum, North Rhine-Westphalia 44791
Germany
Universitaetsklinikum Duesseldorf AoeR - Klinik fuer Neurologie
Düsseldorf, North Rhine-Westphalia 40225
Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden - Medizinische Klinik I
Dresden, Saxony 01307
Germany
Universitaetsklinikum Leipzig AoeR - Klinik und Poliklinik fuer Neurologie
Leipzig, Saxony 04103
Germany
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck - Neurologie
Lübeck, Schleswig-Holstein 23562
Germany
Charité Universitaetsmedizin Berlin - Campus Charité Mitte - Klinik fuer Neurologie
Berlin, 10117
Germany
University General Hospital of Larissa - Rheumatology Clinic
Larissa, 41500
Greece
University Hospital of Patra
Pátrai, 26504
Greece
AHEPA General Hospital of Thessaloniki
Thessaloniki, 54636
Greece
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont - Neurologiai Klinika
Szeged, 6725
Hungary
Nizam's Institute of Medical Sciences
Hyderabad, Andhra Pradesh 500082
India
Yashoda Super Speciality Hospital - 300158817
Hyderabad, Andhra Pradesh 500082
India
Bangalore Medical College and Victoria Hospital - 300148268
Bangalore, Karnataka 560002
India
St John's Medical College Hospital
Bangalore, Karnataka 560034
India
Mallikatta Neurocentre
Mangalore, Karnataka 575001
India
Chopda Medicare & Research Centre - 300188248
Nashik, Maharashtra 422005
India
Deenanath Mangeshkar Hospital and Research Centre - Department of Neurology
Pune, Maharashtra 411030
India
Policlinico Universitario Agostino Gemelli - UOC Neurologia
Rome, Roma 00168
Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni
Bergamo, 24127
Italy
IRCCS Istituto delle Scienze Neurologiche di Bologna - Unità Operativa Complessa Clinica Neurologica
Bologna, 40139
Italy
IRCCS Ospedale Policlinico San Martino - Neuroradiologia
Genova, 16132
Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, 20133
Italy
Fondazione Istituto Neurologico Casimiro Mondino - Neurology
Pavia, 27100
Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata - U.O.C. Neurologia
Roma, 00133
Italy
Ospedale ca' Foncello - Neurology
Treviso, 31100
Italy
Chiba University Hospital - Dept of Neurology
Chiba, Chiba 260-8677
Japan
IUHW Narita Hospital - Dept of Neurology
Narita-shi, Chiba 286-8520
Japan
Fukuoka University Hospital - Dept of Neurology/Health Care
Fukuoka, Fukuoka 814-0180
Japan
Southern Tohoku Medical Clinic - Dept of Neurology
Koriyama-shi, Fukushima 963-8563
Japan
Hakodate Municipal Hospital - Dept of Neurology
Hakodate-shi, Hokkaido 392006
Japan
General Hanamaki Hospital - Dept of Neurology
Hanamaki-shi, Iwate 025-0082
Japan
Kagawa University Hospital - Dept of Neurology
Kita-gun, Kagawa-ken 7610793
Japan
Nagasaki University Hospital - Dept of Neurology
Nagasaki, Nagasaki 852-8501
Japan
Saitama Medical University Hospital - Dept of Neurology/Stroke Care Unit
Iruma-gun, Saitama 350-0495
Japan
Toho University Ohashi Medical Center - Dept of Neurology
Meguro-ku, Tokyo-To 153-8515
Japan
Tokyo Medical University Hospital - Dept of Neurology
Shinjuku-ku, Tokyo-To 160-0023
Japan
Osaka University Hospital - Dept of Neurology/Stroke Care Unit
Suita-shi,
Japan
Uniwersyteckie Centrum Kliniczne - Dept of Neurology
Gdansk, 80-214
Poland
SP ZOZ Szpital Uniwersytecki w Krakowie - Zespó
Krakow, 30-688
Poland
Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii Klinicznej
Krakow, 31-505
Poland
MTZ Clinical Research Powered By Pratia
Warsaw, 02-091
Poland
Wielospecjalistyczne Centrum Medyczne Ibismed - Dept of Neurology
Zabrze,
Poland
Institutul Clinic Fundeni - parent
Bucharest, 022328
Romania
S.C Neurocity S.R.L
Bucharest, 040215
Romania
Brainaxy Clinic S.R.L.
Constanța, 900591
Romania
Spitalul Clinic Judetean de Urgenta Targu Mures - Sectia Clinica Neurologie I
Târgu Mureş, 540136
Romania
Kyungpook National University Chilgok Hospital
Daegu, 41404
South Korea
Chonnam National University Hospital
Gwangju, 61469
South Korea
Samsung Medical Center
Seoul, 06351
South Korea
Korea University Anam Hospital
Seoul, 136-705
South Korea
Asan Medical Center
Seoul, 138-736
South Korea
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 156707
South Korea
Keimyung University Dongsan Hospital
Seoul,
South Korea
Hospital Universitari Germans Trias i Pujol - Servicio de Neurologia
Badalona, Barcelona 08916
Spain
Hospital Universitario Reina Sofia - Neurology Dept
Córdoba, Córdoba 14004
Spain
Hospital Universitario Central de Asturias - Servicio de Neurologia
Oviedo, Principality of Asturias 33011
Spain
Hospital Universitari Vall d'Hebron - Neurology Dept
Barcelona, 08035
Spain
Hospital Universitari i Politecnic La Fe - Pediatry Department
Valencia, 46026
Spain
Sahlgrenska Sjukhuset
Göteborg, 41345
Sweden
Centralsjukhuset Karlstad
Karlstad, 65230
Sweden
Danderyd Sjukhus - 300147691
Stockholm, 18288
Sweden
Inselspital - Universitaetsspital Bern - Neuropsychologische Rehabilitation, Neurologie
Bern, 3010
Switzerland
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
Taiwan
China Medical University Hospital
Taichung, 404327
Taiwan
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, 111
Taiwan
Taipei Veterans General Hospital
Taipei, 11217
Taiwan
Hacettepe University Medical Faculty - Neurology Department
Ankara, 06100
Turkey (Türkiye)
Ondokuz Mayis Univ. Med. Fac. - Neurology
Atakum/SAMSUN, 55270
Turkey (Türkiye)
Kocaeli University Medical Faculty - Neurology Department
Kocaeli, 41380
Turkey (Türkiye)
Mersin University Medical Faculty - Neurology Department
Mersin, 33079
Turkey (Türkiye)
Karadeniz Tecnical Uni. Med. Fac. - Neurology Departmen
Trabzon, 61080
Turkey (Türkiye)
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire NG7 2UH
United Kingdom
Royal Hallamshire Hospital - Dept of Neurology
Sheffield, South Yorkshire S10 2JF
United Kingdom