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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-09-30

Brief Summary

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

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Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

CS-0777 tablets

Intervention Type DRUG

0.1 mg, once-weekly, for 12 weeks

2

Group Type EXPERIMENTAL

CS-0777 tablets

Intervention Type DRUG

0.3 mg, once-weekly or once every 2 weeks, for 12 weeks

3

Group Type EXPERIMENTAL

CS-0777 tablets

Intervention Type DRUG

0.6 mg, once-weekly or once every 2 weeks, for 12 weeks

Interventions

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CS-0777 tablets

0.1 mg, once-weekly, for 12 weeks

Intervention Type DRUG

CS-0777 tablets

0.3 mg, once-weekly or once every 2 weeks, for 12 weeks

Intervention Type DRUG

CS-0777 tablets

0.6 mg, once-weekly or once every 2 weeks, for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No