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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00616733
Recruitment Status : Completed
First Posted : February 15, 2008
Last Update Posted : March 10, 2011
Information provided by:
Daiichi Sankyo, Inc.

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: CS-0777 tablets Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: CS-0777 tablets
0.1 mg, once-weekly, for 12 weeks

Experimental: 2 Drug: CS-0777 tablets
0.3 mg, once-weekly or once every 2 weeks, for 12 weeks

Experimental: 3 Drug: CS-0777 tablets
0.6 mg, once-weekly or once every 2 weeks, for 12 weeks

Primary Outcome Measures :
  1. Safety and tolerability. [ Time Frame: 12 weeks, with 4 weeks to follow-up ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00616733

United States, Colorado
Denver, Colorado, United States
United States, Florida
Port Orange, Florida, United States
United States, Kansas
Lenexa, Kansas, United States
United States, Montana
Billings, Montana, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
Daiichi Sankyo, Inc.

Responsible Party: James Moberly, PhD, Senior Director, Clinical Development, Daiichi Sankyo, Inc. Identifier: NCT00616733     History of Changes
Other Study ID Numbers: CS0777-A-U102
IND 77,409
First Posted: February 15, 2008    Key Record Dates
Last Update Posted: March 10, 2011
Last Verified: March 2011

Keywords provided by Daiichi Sankyo, Inc.:
Multiple sclerosis, relapsing, secondary progressive, clinically isolated syndrome, MRI

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases