Placebo Controlled Study in Subjects With Relapsing Forms of MS to Evaluate the Safety, Tolerability and Effects of CDP323
NCT ID: NCT00484536
Last Updated: 2011-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
232 participants
INTERVENTIONAL
2007-05-31
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CDP323 1000 mg/day
CDP323
250 mg capsules, 500 mg bid (1000 mg/day)
CDP323 500 mg/day
CDP323
250 mg Capsules, 500 mg, once daily
Placebo
placebo
capsules, once daily
Interventions
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CDP323
250 mg capsules, 500 mg bid (1000 mg/day)
placebo
capsules, once daily
CDP323
250 mg Capsules, 500 mg, once daily
Eligibility Criteria
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Inclusion Criteria
* screening EDSS score 0 - 5.5, inclusive
* at least one clinical relapse in the 12 months before screening
* active disease, defined by set of MRI activity criteria
* failed prior treatment with beta-interferons or glatiramer acetate
Exclusion Criteria
* known allergy to gadolinium-DTPA, and/or ingredients of the study drug formulation
* pre-treatment with immunosuppressive or immunomodulatory drugs prior to screening within certain time frames
18 Years
55 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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Cullman, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Springs, Colorado, United States
Washington D.C., District of Columbia, United States
Maitland, Florida, United States
Atlanta, Georgia, United States
Northbrook, Illinois, United States
Fort Wayne, Indiana, United States
Kansas City, Kansas, United States
Lenexa, Kansas, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Farmington Hills, Michigan, United States
Charlotte, North Carolina, United States
Columbus, Ohio, United States
Providence, Rhode Island, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Kirkland, Washington, United States
Charleston, West Virginia, United States
Milwaukee, Wisconsin, United States
Diepenbeek, , Belgium
Ghent, , Belgium
Melsbroek, , Belgium
Overpelt, , Belgium
Sijsele, , Belgium
Sint-Truiden, , Belgium
London, Ontario, Canada
Ottawa, Ontario, Canada
Gatineau, Quebec, Canada
Greenfield Park, Quebec, Canada
Sherbrooke, Quebec, Canada
Oulu, , Finland
Tampere, , Finland
Turku, , Finland
Besançon, , France
Clermont-Ferrand, , France
Lyon, , France
Rennes, , France
Strasbourg, , France
Bayreuth, , Germany
Berlin, , Germany
Giessen, , Germany
Hamburg, , Germany
Marburg, , Germany
Rostock, , Germany
Ulm, , Germany
Wiesbaden, , Germany
Budapest, , Hungary
Győr, , Hungary
Nyíregyháza, , Hungary
Pécs, , Hungary
Amsterdam, , Netherlands
Breda, , Netherlands
Nieuwegein, , Netherlands
Nijmegen, , Netherlands
Barcelona, , Spain
Bilbao, , Spain
Girona, , Spain
Madrid, , Spain
Málaga, , Spain
Oviedo, , Spain
Santa Cruz de Tenerife, , Spain
Seville, , Spain
Gothenburg, , Sweden
Umeå, , Sweden
Hartshill, , United Kingdom
Newcastle, , United Kingdom
Nottingham, , United Kingdom
Sheffield, , United Kingdom
Countries
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Other Identifiers
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2006-002204-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C32322
Identifier Type: -
Identifier Source: org_study_id
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