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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00616733

Enrollment

Registered

2008-02-15

Start date

2008-03-31

Completion date

2010-09-30

Last updated

2011-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis, relapsing, secondary progressive, clinically isolated syndrome, MRI

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.

Interventions

DRUGCS-0777 tablets

0.1 mg, once-weekly, for 12 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Safety and tolerability.	12 weeks, with 4 weeks to follow-up

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026