12-week Safety Evaluation of Oral CS-0777 in Multiple Sclerosis Patients
An Open-label, Escalating-dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral CS-0777, Administered for 12 Weeks, in Patients With Multiple Sclerosis
2 other identifiers
interventional
25
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 multiple-sclerosis
Started Mar 2008
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2008
CompletedFirst Posted
Study publicly available on registry
February 15, 2008
CompletedStudy Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedMarch 10, 2011
March 1, 2011
2.5 years
February 4, 2008
March 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability.
12 weeks, with 4 weeks to follow-up
Secondary Outcomes (1)
Pharmacodynamic response (lymphocyte counts Pharmacokinetics Exploratory efficacy based on brain MRI lesions)
12 weeks, with 4 weeks to follow up.
Study Arms (3)
1
EXPERIMENTAL2
EXPERIMENTAL3
EXPERIMENTALInterventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (5)
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Port Orange, Florida, United States
Unknown Facility
Lenexa, Kansas, United States
Unknown Facility
Billings, Montana, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 4, 2008
First Posted
February 15, 2008
Study Start
March 1, 2008
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
March 10, 2011
Record last verified: 2011-03