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

Sponsor:	Daiichi Sankyo Inc.
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00616733

Purpose

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

Condition	Intervention	Phase
Multiple Sclerosis	Drug: CS-0777 tablets	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:

Safety and tolerability. [ Time Frame: 12 weeks, with 4 weeks to follow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacodynamic response (lymphocyte counts Pharmacokinetics Exploratory efficacy based on brain MRI lesions) [ Time Frame: 12 weeks, with 4 weeks to follow up. ] [ Designated as safety issue: No ]

Enrollment:	25
Study Start Date:	March 2008
Study Completion Date:	September 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616733

Locations

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.

More Information

No publications provided

Responsible Party:	James Moberly, PhD, Senior Director, Clinical Development, Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier:	NCT00616733 History of Changes
Other Study ID Numbers:	CS0777-A-U102, IND 77,409
Study First Received:	February 4, 2008
Last Updated:	March 9, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:

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

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases

Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012