Back to results12-week Safety Evaluation of Oral CS-0777 in Multiple Sclerosis Patients
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CS-0777 tablets
CS-0777 tablets
CS-0777 tablets
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple sclerosis, relapsing, secondary progressive, clinically isolated syndrome, MRI
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
1
2
3
Arm Description
Outcomes
Primary Outcome Measures
Safety and tolerability.
Secondary Outcome Measures
Pharmacodynamic response (lymphocyte counts Pharmacokinetics Exploratory efficacy based on brain MRI lesions)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00616733
Brief Title
12-week Safety Evaluation of Oral CS-0777 in Multiple Sclerosis Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Daiichi Sankyo, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple sclerosis, relapsing, secondary progressive, clinically isolated syndrome, MRI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CS-0777 tablets
Intervention Description
0.1 mg, once-weekly, for 12 weeks
Intervention Type
Drug
Intervention Name(s)
CS-0777 tablets
Intervention Description
0.3 mg, once-weekly or once every 2 weeks, for 12 weeks
Intervention Type
Drug
Intervention Name(s)
CS-0777 tablets
Intervention Description
0.6 mg, once-weekly or once every 2 weeks, for 12 weeks
Primary Outcome Measure Information:
Title
Safety and tolerability.
Time Frame
12 weeks, with 4 weeks to follow-up
Secondary Outcome Measure Information:
Title
Pharmacodynamic response (lymphocyte counts Pharmacokinetics Exploratory efficacy based on brain MRI lesions)
Time Frame
12 weeks, with 4 weeks to follow up.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Denver
State/Province
Colorado
Country
United States
City
Port Orange
State/Province
Florida
Country
United States
City
Lenexa
State/Province
Kansas
Country
United States
City
Billings
State/Province
Montana
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
12. IPD Sharing Statement
Learn more about this trial
12-week Safety Evaluation of Oral CS-0777 in Multiple Sclerosis Patients
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