12-week Safety Evaluation of Oral CS-0777 in Multiple Sclerosis Patients - NCT00616733- (Clinical Trial 202944)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy202944.aspx
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Philadelphia |
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State:
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PA |
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| Conditions: |
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Multiple Sclerosis |
| Purpose: |
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This is a 12-week study to assess the safety, tolerability, pharmacokinetics and
pharmacodynamics of oral CS-0777 in patients with Multiple Sclerosis.
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| Study summary: |
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| Criteria: |
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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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| Study is available at: |
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Philadelphia, PA
United States
Primary Contact:
Sharon Herbert, PhD
Email: S.Herbert@Medpace.com |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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