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12-week Safety Evaluation of Oral CS-0777 in Multiple Sclerosis Patients - NCT00616733-(Clinical Trial 202944)



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City:  Philadelphia
State:  
PA
Zip Code:
Conditions: Multiple Sclerosis
Purpose: This is a 12-week study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of oral CS-0777 in patients with Multiple Sclerosis.
Study summary:
Criteria: Inclusion Criteria: - Diagnosis of clinically isolated syndrome or a relapsing form(s) of MS, based on Poser or McDonald criteria (may include patients with secondary progressive disease) - Clinical relapse within the past 3 years or a gadolinium enhancing lesion on a brain MRI scan within the past 12 months - Baseline EDSS score of 0 - 6.5 - Female subjects who are sexually active, unless sterile or post-menopausal for at least 1 year, must be willing to use double-barrier contraception Exclusion Criteria: - Primary progressive MS - Any medical condition that predisposes to immunocompromise - History of malignancy, tuberculosis, invasive fungal infections, herpes zoster infection (or shingles), or other opportunistic infection, or any current active infection - Concurrent diagnosis of any other autoimmune disease (eg, rheumatoid arthritis or lupus) - Treatment with cyclophosphamide or mitoxantrone within 6 months of study initiation - Treatment with cyclosporine, azathioprine, methotrexate or other immunosuppressant within 3 months of study initiation - Treatment with interferon beta or glatiramer acetate within 2 months of study initiation - Prior treatment with natalizumab or rituximab
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Data Source: ClinicalTrials.gov
Date Processed: June 22, 2010
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