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Sponsored by: |
Alexion Pharmaceuticals |
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Information provided by: | Alexion Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00727194 |
The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of patients with generalized myasthenia gravis despite treatment with various immunosuppressants, such as prednisone, methotrexate, Cellcept, cyclosporine, and cyclophosphamide, that are currently available.
Condition | Intervention | Phase |
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Myasthenia Gravis |
Drug: eculizumab Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Multi-Center Study of Eculizumab in Patients With Generalized Myasthenia Gravis (gMG) Who Have Moderate to Severe Muscle Weakness Despite Treatment With Immunosuppressants |
Estimated Enrollment: | 24 |
Study Start Date: | October 2008 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
eculizumab
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Drug: eculizumab
eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 my IV every two weeks for 7 doses
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2: Placebo Comparator
Placebo
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Drug: Placebo
Placebo IV weekly for 4 doses then every two weeks for 7 doses
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jing Jing Wang, MD | 203-271-8348 | wangj@alxn.com |
Responsible Party: | Alexion Pharmaceuticals ( Jing Jing Wang, MD. Associate Medical Director ) |
Study ID Numbers: | C08-001 |
Study First Received: | July 30, 2008 |
Last Updated: | October 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00727194 |
Health Authority: | United States: Food and Drug Administration |
Autoimmune Diseases Neuromuscular Diseases Asthenia Myasthenia gravis |
Myasthenia Gravis Muscle Weakness Autoimmune Diseases of the Nervous System |
Immune System Diseases Nervous System Diseases Neuromuscular Junction Diseases |