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Spots Global Cancer Trial Database for A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Participants With Secondary Progressive Multiple Sclerosis

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Trial Identification

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

Interventions

natalizumab
Placebo

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Medical Director

Affiliation: Biogen

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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