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

March 9, 2011 updated by: Daiichi Sankyo, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States
    • Florida
      • Port Orange, Florida, United States
    • Kansas
      • Lenexa, Kansas, United States
    • Montana
      • Billings, Montana, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: CS-0777 tablets
0.1 mg, once-weekly, for 12 weeks
Drug: CS-0777 tablets
0.3 mg, once-weekly or once every 2 weeks, for 12 weeks
Drug: CS-0777 tablets
0.6 mg, once-weekly or once every 2 weeks, for 12 weeks
Experimental: 2
Drug: CS-0777 tablets
0.1 mg, once-weekly, for 12 weeks
Drug: CS-0777 tablets
0.3 mg, once-weekly or once every 2 weeks, for 12 weeks
Drug: CS-0777 tablets
0.6 mg, once-weekly or once every 2 weeks, for 12 weeks
Experimental: 3
Drug: CS-0777 tablets
0.1 mg, once-weekly, for 12 weeks
Drug: CS-0777 tablets
0.3 mg, once-weekly or once every 2 weeks, for 12 weeks
Drug: CS-0777 tablets
0.6 mg, once-weekly or once every 2 weeks, for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability.
Time Frame: 12 weeks, with 4 weeks to follow-up
12 weeks, with 4 weeks to follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

February 4, 2008

First Submitted That Met QC Criteria

February 4, 2008

First Posted (Estimate)

February 15, 2008

Study Record Updates

Last Update Posted (Estimate)

March 10, 2011

Last Update Submitted That Met QC Criteria

March 9, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS0777-A-U102
  • IND 77,409

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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