Status:
COMPLETED
12-week Safety Evaluation of Oral CS-0777 in Multiple Sclerosis Patients
Lead Sponsor:
Daiichi Sankyo
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This is a 12-week study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of oral CS-0777 in patients with Multiple Sclerosis.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00616733
Start Date
March 1 2008
End Date
September 1 2010
Last Update
March 10 2011
Active Locations (5)
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1
Denver, Colorado, United States
2
Port Orange, Florida, United States
3
Lenexa, Kansas, United States
4
Billings, Montana, United States