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

Completed · Phase 1

Conditions studied: Multiple Sclerosis

In brief

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

Key facts

Study ID

NCT00616733

Run by

Daiichi Sankyo

People needed

25

Starts

2008-03-01

Expected to finish

2010-09-01

Last updated by the study team

2011-03-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Denver, Colorado, United States
• Study site — Port Orange, Florida, United States
• Study site — Lenexa, Kansas, United States
• Study site — Billings, Montana, United States
• Study site — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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