Overview
12-week Safety Evaluation of Oral CS-0777 in Multiple Sclerosis Patients
Status:
Completed
Completed
Trial end date:
2010-09-01
2010-09-01
Target enrollment:
0
0
Participant gender:
All
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 1Accepts Healthy Volunteers?
NoDetails
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