12-week Safety Evaluation of Oral CS-0777 in Multiple Sclerosis Patients

Phase 1

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: CS-0777 tablets

• Registration Number: NCT00616733
• Lead Sponsor: Daiichi Sankyo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-04
• Study First Submitted QC: 2008-02-04
• Study First Posted: 2008-02-15
• Study Start: 2008-03
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-09
• Last Update Posted: 2011-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	CS-0777 tablets	-
1	CS-0777 tablets	-
2	CS-0777 tablets	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability.	12 weeks, with 4 weeks to follow-up

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamic response (lymphocyte counts Pharmacokinetics Exploratory efficacy based on brain MRI lesions)	12 weeks, with 4 weeks to follow up.