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