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Study 1 of 13 for search of: | "Polyradiculoneuropathy" |
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Sponsored by: |
Biogen Idec |
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Information provided by: | Biogen Idec |
ClinicalTrials.gov Identifier: | NCT00099489 |
The purpose of this study is to determine whether AVONEX (Interferon Beta-1a), when compared to placebo, reduces the total dose of IVIg that is administered after Visit 5 and through Visit 9 (Week 32, End of Study).
Condition | Intervention | Phase |
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Chronic Inflammatory Demyelinating Polyradiculoneuropathy |
Drug: Interferon Beta-1a |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Safety and Efficacy of AVONEX When Used in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) |
Estimated Enrollment: | 67 |
Study Start Date: | February 2004 |
Estimated Study Completion Date: | March 2006 |
Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) is an acquired peripheral neuropathy of unknown origin. The etiology is not well understood but is presumed to be immunological. Evidence for this comes from observed similarities to Guillain-Barre syndrome and from the favorable response with immunomodulatory treatments.
CIDP is a peripheral nervous system demyelinating neuropathy that is sometimes a corollary disorder to the central nervous system demyelination of multiple sclerosis (MS. The precise mechanisms underlying the pathogenesis are uncertain, but a number of those mechanisms support a potential role for immunomodulatory treatments such as interferon beta (e.g., Biogen Idec Inc.'s AVONEX).
The rationale for the use of AVONEX in CIDP derives from observations on the pathogenesis of the condition and its similarities to MS, the mechanism of action of AVONEX, clinical trials that have been performed in CIDP that support a role for IFN-beta, and the unmet need that currently exists because of availability and safety issues with existing therapies.
This Phase 2b study is a dose-ranging study designed to provide scientific evidence regarding the safety and efficacy of AVONEX in CIDP. In addition, the study aims to demonstrate the responsiveness and clinical relevance of changes in the MRC sum score and ODSS in CIDP patients.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria*:
Female subjects who are currently pregnant or breast-feeding.
United States, Arizona | |
Phoenix Neurological Associates, Ltd. | |
Phoenix, Arizona, United States, 85006 | |
Neuromuscular Research Center | |
Scottsdale, Arizona, United States, 85258 | |
United States, Florida | |
University of Miami | |
Miami, Florida, United States, 33136 | |
University of Florida, Jacksonville | |
Jacksonville, Florida, United States, 32209 | |
United States, Kansas | |
University of Kansas | |
Kansas City, Kansas, United States, 66160 | |
United States, Louisiana | |
Louisiana State University | |
New Orleans, Louisiana, United States, 70112 | |
United States, Massachusetts | |
Harvard University/MGH | |
Boston, Massachusetts, United States, 02114 | |
Tufts University/ St. Elizabeths | |
Boston, Massachusetts, United States, 02135 | |
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 | |
United States, New York | |
Weill Medical College of Cornell University | |
New York, New York, United States, 10022 | |
United States, North Carolina | |
Raleigh Neurology Associates | |
Raleigh, North Carolina, United States, 27607 | |
United States, Texas | |
University of Texas Southwestern | |
Dallas, Texas, United States, 75390-8897 | |
United States, Utah | |
University of Utah | |
Salt Lake City, Utah, United States, 84132 | |
Australia, New South Wales | |
Liverpool Hospital | |
Liverpool, New South Wales, Australia, 2170 | |
Institute of Clinical Neurosciences | |
Sydney, New South Wales, Australia, 2006 | |
Australia, Victoria | |
Royal Melbourne Hospital | |
Parkville, Victoria, Australia, 3050 | |
St. Vincent's Hospital | |
Fitzroy, Victoria, Australia, 3065 | |
Canada, Ontario | |
London Health Sciences Center | |
London, Ontario, Canada, N6A 5A5 | |
Canada, Quebec | |
Montreal Neurological Hospital | |
Montreal, Quebec, Canada, H3A 2B4 | |
United Kingdom | |
Guy's Hospital/Dept. of Neuroimmunology | |
London, United Kingdom, SE1 1UL |
Principal Investigator: | Allan Ropper, MD | Tufts University School of Medicine, St. Elizabeth's Medical Center |
Study Director: | Kate Dawson, MD | Biogen Idec |
Study ID Numbers: | C-870 |
Study First Received: | December 15, 2004 |
Last Updated: | February 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00099489 |
Health Authority: | United States: Food and Drug Administration |
Chronic Inflammatory Demyelinating Polyradiculoneuropathy CIDP IVIg AVONEX |
Autoimmune Diseases Demyelinating Diseases Polyradiculoneuropathy Interferons Polyneuropathies Interferon-beta Demyelinating diseases |
Chronic inflammatory demyelinating polyneuropathy Polyradiculoneuropathy, Chronic Inflammatory Demyelinating Neuromuscular Diseases Peripheral Nervous System Diseases Interferon beta 1a Autoimmune Diseases of the Nervous System |
Anti-Infective Agents Immunologic Factors Immune System Diseases Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Nervous System Diseases Adjuvants, Immunologic Antiviral Agents Pharmacologic Actions |