Effect of MD1003 in Progressive Multiple Sclerosis: a Randomized Double Blind Placebo Controlled Study

Status: Terminated
Location: See all (87) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the disability of patients suffering from progressive multiple sclerosis and especially those with gait impairment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: No
View:

• Patient aged 18-65 years old

• Signed and dated written informed consent form in accordance with local regulations: having freely given their written informed consent to participate in the study

• Diagnosis of primary or secondary progressive MS fulfilling revised McDonald criteria (2010) and Lublin criteria (2014)

• Documented evidence of clinical disability progression within the 2 years prior to inclusion, i.e. a) progression of EDSS during the past two years of at least 1 point sustained for at least 6 months if inclusion EDSS is from 3.5 to 5.5 or at least 0.5 point increase sustained for at least 6 months if inclusion EDSS is from 6 to 6.5 or b) increase of TW25 by at least 20% in the last two years sustained for at least 6 months or c) other well-documented objective worsening validated by the Adjudication Committee

• EDSS at inclusion from 3.5 to 6.5

• TW25 < 40 seconds at inclusion visit

• Kurtzke pyramidal functional subscore ≥2 defined as minimal disability: patient complains of motor-fatigability or reduced performance in strenuous motor tasks (motor performance grade 1) and/or BMRC grade 4 in one or two muscle groups

Locations
United States
Arizona
Barrow Neurology Clinics (BNC)
Phoenix
Mayo Clinic Scottsdale
Scottsdale
California
Jordan Research And Education Institute Of Alta Bates Summit
Berkeley
Neuro-Pain Medical Center
Fresno
University of Southern California Keck School of Medicine
Los Angeles
MS Center of California
Newport Beach
UC Davis Health System
Sacramento
UCSF Multiple Sclerosis Center
San Francisco
Colorado
University of Colorado Denver
Aurora
Connecticut
Yale New Haven Hospital
North Haven
Florida
Nova Clinical Research, LLC
Bradenton
University of Miami Miller School of Medicine
Miami
University of South Florida - Neurology
Tampa
Illinois
Northwestern University - Feinberg School of Medicine
Chicago
University of Chicago Medical Center-Duchossois Center for Advanced Medicine (DCAM)
Chicago
Kansas
University of Kansas Medical Center
Kansas City
Rowe Neurology Institute
Lenexa
Louisiana
Ochsner Health System
New Orleans
Massachusetts
Harvard Medical School - Brigham and Women's Hospital - Center for Neurologic Diseases
Boston
Maryland
The Johns Hopkins Outpatient Center
Baltimore
Michigan
Wayne State University - Comp Clinic and MS Center
Detroit
Minnesota
Minneapolis Clinic of Neurology, LTD
Golden Valley
Missouri
Washington University School of Medicine
Saint Louis
North Carolina
Raleigh Neurology Associates, P.A.
Raleigh
New Jersey
Holy Name Hospital
Teaneck
New Mexico
The University of New Mexico - Multiple Sclerosis Specialty Clinic
Albuquerque
New York
UBMD Neurology
Buffalo
Columbia University Medical Center
New York
Mount Sinai School of Medicine - Corinne Goldsmith Dickinson Center for MS
New York
University of Rochester Medical Center
Rochester
State University of New York (SUNY)
Stony Brook
Ohio
Cleveland Clinic Mellen Center for MS
Cleveland
Oregon
Providence Multiple Sclerosis Center
Portland
Pennsylvania
Thomas Jefferson University
Philadelphia
Tennessee
New Orleans Center for Clinical Research
Knoxville
Vanderbilt Comprehensive Multiple Sclerosis Center
Nashville
Texas
University of Texas Southwestern Medical Center
Dallas
Central Texas Neurology Consultants
Round Rock
Virginia
University of Virginia Health System
Charlottesville
Washington
Virginia Mason Medical Center
Seattle
Other Locations
Australia
Austin Hospital
Heidelberg
The Royal Melbourne Hospital
Parkville
Brain and Mind Centre/University of Sydney
Sydney
Belgium
UZ Antwerpen
Edegem
UZ Gent
Halle
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt
Canada
Burnaby Hospital
Burnaby
Nova Scotia Rehabilitation Center
Halifax
Hôpital universitaire Dr George L-Dumont university Hospital
Moncton
Montreal Neurologic Institute
Montreal
Hopital de Notre Dame
Montréal
Ottawa Hospital General Campus
Ottawa
St. Michael's Hospital
Toronto
Vancouver Hospital and Health Sciences Centre
Vancouver
Germany
Caritas Krankenhaus
Bad Mergentheim
Charité - Universitätsmedizin Berlin / NeuroCure Clinical Research Center
Berlin
Heinrich-Heine-Universität Düsseldorf
Dusseldorf
Neuro Centrum Science GmbH
Erbach
MultipEL Studies Institut für klinische Studien GbR
Hamburg
Universitätsklinikum Leipzig A.ö.R. - Klinik und Poliklinik
Leipzig
Ludwig-Maximilians Universität München
München
Neuropoint GmbH
Ulm
Poliklinik für Neurologie Universitätsklinikum Ulm
Ulm
Fachkrankenhaus Hubertusburg
Wermsdorf
Hungary
Valeomed Kft
Esztergom
Italy
Ospedale San Raffaele, IRCCS
Milano
AO S.Andrea, Università degli Studi di Roma La Sapienza
Roma
Poland
Nasz Lekarz Ośrodek Badań Klinicznych
Bydgoszcz
COPERNICUS PL sp z o.o.,Szpital im. M.Kopernika Oddział Neurologiczny
Gdansk
Twoja Przychodnia Centrum Medyczne Nowa Sol
Nowa Sol
Centrum Medyczne Pratia Warszawa
Warszawa
Spain
Hospital del Mar Servicio de Neurología
Barcelona
Hospital Universitari Vall d'Hebron
Barcelona
Servicio de Neurología Hospital Vithas Nisa Aljarafe
Castilleja De La Cuesta
Hospital Clínico San Carlos
Madrid
Hospital Regional Universitario de Málaga
Malaga
Hostipal Universitario Quirónsalud Madrid
Pozuelo De Alarcón
Hospital Santa Caterina
Salt
Sweden
Sahlgrenska Universitetssjukhus - MS Center forskningsenheten
Göteborg
Karolinska University Hospital - Neurologmottagningen
Stockholm
Turkey
Ondokuz Mayis University Medical Faculty
Samsun
United Kingdom
The University of Edinburgh
Edinburgh
Institute of Neurological Sciences
Glasgow
Barts And The London School Of Medicine And Dentistry Institute
London
University College London Institute of Neurology / National Hospital for Neurology & Neurosurgery
London
Tyne Hospitals NHS Foundation
Newcastle Upon Tyne
Salford Royal Hospital
Salford
Time Frame
Start Date: December 2016
Completion Date: April 23, 2020
Participants
Target number of participants: 642
Treatments
Placebo Comparator: GROUP 1
Placebo capsule, 1 capsule tid (morning,noon and evening) for 15 months and up to 27 months.
Experimental: GROUP 2
MD1003 capsule, 1 capsule tid (morning,noon and evening) for 15 months and up to 27 months.
Authors
Don Mahad, Jonathan Calkwood, John Corboy, Lilyana Amezcua, Robert Naismith, Lawrence Samkoff, Harold Moses, Brian Steingo, Sharon Lynch, Bruce Cohen, Sanjay Yathiraj, Aimee Borazanci, Perminder Bhatia, Myla Goldman, Mark Freedman, Claire Riley, Derrick Robertson, Mark Agius, Thomas Leist, Daniel S Bandari, Devon Conway, Benjamin Greenberg, Patricia Coyle, Jana Lizrova Preiningerova, Jonathan Carter, Andrew Goodman, Kottil Rammohan, Kyle Smoot, Michelle Apperson, Heidi Crayton, Jonathan Cahill, Bridget Bagert, Fred D Lublin, Sharon Stoll, Anthony Reder, Shiv Saidha, Adam Carpenter, Evanthia Bernitsas, Radomir Talab, Tumani Hayrettin, Malgorzata Zajda, Jozef Koscielniak, Ludivine Witkowski, Birte Elias-Hamp, Daniela Rau, John Foley, Wolfgang Köhler, Gerd Reifschneider, Refik Pul, Tjalf Ziemssen, Piotr Sokolowski, Ahmed Toosy, Friedemann Paul, Mathias Buttmann, Tania Kümpfel, Joanna Cooper, Joe Guadagno, Adrian Pace, Waldemar Fryze, Vernon Rowe, Roger McKelvey, Alex Rae-Grant, Péter Diószeghy, Elske Hoitsma, Sámuel Komoly, Gabor Jakab, Joshua BARTON, Hans Peter Hartung, Radek Ampapa, Zoltán Szakacs, Lou Brundin, Maria Satori, Raymond Hupperts, Jacek Zaborski, Mark Marriott, Corey Ford, Belgin Petek Balci, Guy Laureys, Marta Vachova, Virginia Devonshire, Neil SHUEY, Paul Giacomini, Nina De Klippel, Bruce Cree, Marek Zalisz, Frequin, Kita Mariko, Schmierer Klaus, Fox Edward, J.Marc Girard, Agata Klosek, Julián Benito León, Mitchell Freedman, James Marriott, Randy Trudell, Webb Stewart, Victoria Fernández Sánchez, Aaron E Miller, Ángel Pérez-Sempere, Lászlo Vécsei, Bianca Weinstock-Guttman, Andrzej Szczudlik, Eva Meluzinova, Daniel Selchen, Murat Terzi, Mary Ann Picone, Guillermo Izquierdo Ayuso, Galina Vorobeychik, David Paling, Lluís Ramió i Torrentá, Ilknur Aydin Canturk, Gaetano Perrotta, Celia Oreja Guevara, Katherine Buzzard, Cavit Boz, Rafael Arroyo, Mark Slee, Christopher Severson, Richard Macdonell, Bart Van Wijmeersch, Jose Martínez Rodríguez, Simon Broadley, Aktas Orhan, Barbara Willekens, Jeannette Lechner-Scott, Giancarlo Comi, Carlo Pozzilli, Rana Karabudak, Jan Lycke, Xavier Montalbán
Sponsors
Leads: MedDay Pharmaceuticals SA

This content was sourced from clinicaltrials.gov

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