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

Daiichi Sankyo

Status and phase: Completed; Phase 1

Conditions: Multiple Sclerosis

Treatments: Drug: CS-0777 tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00616733

CS0777-A-U102

IND 77,409

Details and patient eligibility

About

This is a 12-week study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of oral CS-0777 in patients with Multiple Sclerosis.

Enrollment: 25 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 3 patient groups

1

Experimental group

Treatment:

Drug: CS-0777 tablets

Drug: CS-0777 tablets

Drug: CS-0777 tablets

2

Experimental group

Treatment:

Drug: CS-0777 tablets

Drug: CS-0777 tablets

Drug: CS-0777 tablets

3

Experimental group

Treatment:

Drug: CS-0777 tablets

Drug: CS-0777 tablets

Drug: CS-0777 tablets