The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Participants With Secondary Progressive Multiple Sclerosis
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With Optional Open-Label Extension
Study ID: NCT01416181
Brief Summary: This is a Phase 3b, multicenter, international study conducted in 2 parts. Upon completion of the placebo-controlled period (Part 1), participants will have the option of enrolling in a 2-year open-label extension (Part 2). Part 1: The primary objective of the study is to investigate whether treatment with natalizumab slows the accumulation of disability not related to relapses in participants with secondary progressive multiple sclerosis (SPMS). The secondary objectives of Part 1 of this study are to determine the proportion of participants with consistent improvement in Timed 25-Foot Walk (T25FW), the change in participant-reported ambulatory status as measured by the 12-item MS Walking Scale (MSWS-12), the change in manual ability based on the ABILHAND Questionnaire, the impact of natalizumab on participant-reported quality of life using the Multiple Sclerosis Impact Scale-29 Physical (MSIS-29 Physical), the change in whole brain volume between the end of study and Week 24 using magnetic resonance imaging (MRI) and the proportion of participants experiencing progression of disability as measured by individual physical Expanded Disability Status Scale (EDSS) system scores. Part 2: The primary objective of Part 2 of the study is to evaluate the safety profile of natalizumab in participants with SPMS. The secondary objectives of Part 2 of the study are to investigate long-term disability (based on clinical or participant-reported assessments) in participants with SPMS receiving natalizumab treatment for approximately 4 years and to assess change in brain volume and T2 lesion volume.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: No
Research Site, Phoenix, Arizona, United States
Research Site, Tucson, Arizona, United States
Research Site, Fullerton, California, United States
Research Site, Los Angeles, California, United States
Research Site, Aurora, Colorado, United States
Research Site, Tampa, Florida, United States
Research Site, Chicago, Illinois, United States
Research Site, Lake Barrington, Illinois, United States
Research Site, Peoria, Illinois, United States
Research Site, Indianapolis, Indiana, United States
Research Site, Indianapolis, Indiana, United States
Research Site, Kansas City, Kansas, United States
Research Site, Lexington, Kentucky, United States
Research Site, Lexington, Kentucky, United States
Research Site, Baltimore, Maryland, United States
Research Site, Burlington, Massachusetts, United States
Research Site, Omaha, Nebraska, United States
Research Site, Lebanon, New Hampshire, United States
Research Site, Teaneck, New Jersey, United States
Research Site, Latham, New York, United States
Research Site, New York, New York, United States
Research Site, Advance, North Carolina, United States
Research Site, Charlotte, North Carolina, United States
Research Site, Raleigh, North Carolina, United States
Research Site, Akron, Ohio, United States
Research Site, Uniontown, Ohio, United States
Research Site, Oklahoma City, Oklahoma, United States
Research Site, Clackamas, Oregon, United States
Research Site, Portland, Oregon, United States
Research Site, Portland, Oregon, United States
Research Site, Nashville, Tennessee, United States
Research Site, Charlottesville, Virginia, United States
Research Site, Seattle, Washington, United States
Research Site, Green Bay, Wisconsin, United States
Research Site, Milwaukee, Wisconsin, United States
Research Site, La Louviere, , Belgium
Research Site, Melsbroek, , Belgium
Research Site, Overpelt, , Belgium
Research Site, Calgary, Alberta, Canada
Research Site, Edmonton, Alberta, Canada
Research Site, Vancouver, British Columbia, Canada
Research Site, Halifax, Nova Scotia, Canada
Research Site, Kingston, Ontario, Canada
Research Site, London, Ontario, Canada
Research Site, Ottawa, Ontario, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Gatineau, Quebec, Canada
Research Site, Greenfield Park, Quebec, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Hradec Kralove, Bohemia, Czechia
Research Site, Brno, , Czechia
Research Site, Olomouc, , Czechia
Research Site, Praha, , Czechia
Research Site, Arthus C, , Denmark
Research Site, Esbjerg, , Denmark
Research Site, Glostrup, , Denmark
Research Site, København Ø, , Denmark
Research Site, Odense, , Denmark
Research Site, Jyväskylä, , Finland
Research Site, Tampere, , Finland
Research Site, Turku, , Finland
Research Site, Nice, Alpes Maritimes, France
Research Site, Marseille cedex 5, Bouches-du-Rhône, France
Research Site, Nantes, Loire Atlantique, France
Research Site, Nancy, Meurthe et Moselle, France
Research Site, Lille Cedex, Nord, France
Research Site, Bron cedex, Rhone, France
Research Site, Salouel, Somme, France
Research Site, Bordeaux, , France
Research Site, Bad Wilbad, Baden Wuerttemberg, Germany
Research Site, Tuebingen, Baden Wuerttemberg, Germany
Research Site, Bad Mergentheim, Baden-Wuerttemberg, Germany
Research Site, Muenchen, Bayern, Germany
Research Site, Muenchen, Bayern, Germany
Research Site, Hennigsdorf, Brandenburg, Germany
Research Site, Teupitz, Brandenburg, Germany
Research Site, Kassel, Hessen, Germany
Research Site, Duesseldorf, Nordrhein Westfalen, Germany
Research Site, Muenster, Nordrhein Westfalen, Germany
Research Site, Dresden, Sachsen, Germany
Research Site, Dublin, , Ireland
Research Site, Dublin, , Ireland
Research Site, Jerusalem, , Israel
Research Site, Ramat Gan, , Israel
Research Site, Baggiovara, Modena, Italy
Research Site, Cefalu, Palermo, Italy
Research Site, Gallarate, Varese, Italy
Research Site, Bari, , Italy
Research Site, Florence, , Italy
Research Site, Genova, , Italy
Research Site, Milano, , Italy
Research Site, Milano, , Italy
Research Site, Naples, , Italy
Research Site, Napoli, , Italy
Research Site, Palermo, , Italy
Research Site, Pavia, , Italy
Research Site, Rome, , Italy
Research Site, Rome, , Italy
Research Site, Amsterdam, , Netherlands
Research Site, Breda, , Netherlands
Research Site, Hertogenbosch, , Netherlands
Research Site, Hoorn, , Netherlands
Research Site, Nieuwegein, , Netherlands
Research Site, Sittard-Geleen, , Netherlands
Research Site, Bialystok, , Poland
Research Site, Gdansk, , Poland
Research Site, Katowice, , Poland
Research Site, Katowice, , Poland
Research Site, Katowice, , Poland
Research Site, Krakow, , Poland
Research Site, Lodz, , Poland
Research Site, Lublin, , Poland
Research Site, Olsztyn, , Poland
Research Site, Plewiska, , Poland
Research Site, Poznan, , Poland
Research Site, Szczecin, , Poland
Research Site, Warszawa-Miedzylesie, , Poland
Research Site, Warszawa, , Poland
Research Site, Warszawa, , Poland
Research Site, Warszawa, , Poland
Research Site, Wroclaw, , Poland
Research Site, Belgorod, , Russian Federation
Research Site, Kazan, , Russian Federation
Research Site, Kazan, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, St. Petersburg, , Russian Federation
Research Site, Tyumen, , Russian Federation
Research Site, Barcelona, , Spain
Research Site, Barcelona, , Spain
Research Site, Barcelona, , Spain
Research Site, El Palmar, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Majadahonda, , Spain
Research Site, Málaga, , Spain
Research Site, Santa Cruz de Tenerife, , Spain
Research Site, Sevilla, , Spain
Research Site, Göteborg, , Sweden
Research Site, Stockholm, , Sweden
Research Site, Stockholm, , Sweden
Research Site, Stockholm, , Sweden
Research Site, Umeå, , Sweden
Research Site, Örebro, , Sweden
Research Site, Irvine, Ayrshire, United Kingdom
Research Site, Edgbaston, Birmingham, United Kingdom
Research Site, Exeter, Devon, United Kingdom
Research Site, Plymouth, Devon, United Kingdom
Research Site, London, Greater London, United Kingdom
Research Site, London, Greater London, United Kingdom
Research Site, Hammersmith, London, United Kingdom
Research Site, Edinburgh, Lothian Region, United Kingdom
Research Site, Salford, Manchester, United Kingdom
Research Site, Liverpool, Merseyside, United Kingdom
Research Site, Norwich, Norfolk, United Kingdom
Research Site, Nottingham, Nottinghamshire, United Kingdom
Research Site, Morriston, Swansea, United Kingdom
Research Site, Newcastle, Tyne, United Kingdom
Research Site, Brighton, , United Kingdom
Research Site, London, , United Kingdom
Research Site, Sheffield, , United Kingdom
Name: Medical Director
Affiliation: Biogen
Role: STUDY_DIRECTOR