12-week Safety Evaluation of Oral CS-0777 in Multiple Sclerosis Patients

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a 12-week study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of oral CS-0777 in patients with Multiple Sclerosis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.

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