Overview

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