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

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 Drug: CS-0777 matching placebo tablets	Phase I

MedlinePlus related topics:

Multiple Sclerosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment

Official Title:	A Randomized, Double-Blind, Placebo Controlled, Escalating-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral CS-0777, Administered for 12 Weeks, in Patients With Multiple Sclerosis

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 ]

Estimated Enrollment:	36
Study Start Date:	March 2008
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: CS-0777 tablets 0.1 mg, once-weekly, for 12 weeks
2: Experimental	Drug: CS-0777 tablets 0.3 mg, once-weekly or once every 2 weeks, for 12 weeks
3: Experimental	Drug: CS-0777 tablets 0.6 mg, once-weekly or once every 2 weeks, for 12 weeks
4: Placebo Comparator	Drug: CS-0777 matching placebo tablets 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

Contacts


Contact: Sharon Herbert, PhD		S.Herbert@Medpace.com

Locations


United States, Arizona
		Recruiting
	Phoenix, Arizona, United States

United States, Colorado
		Not yet recruiting
	Denver, Colorado, United States

United States, Florida
		Recruiting
	Port Orange, Florida, United States

United States, Kansas
		Recruiting
	Lenexa, Kansas, United States

United States, Montana
		Recruiting
	Billings, Montana, United States

United States, Pennsylvania
		Not yet recruiting
	Philadelphia, Pennsylvania, United States
		Not yet recruiting
	Johnstown, Pennsylvania, United States

Sponsors and Collaborators

Daiichi Sankyo Inc.

More Information

Responsible Party:	Daiichi Sankyo, Inc. ( James Moberly, PhD, Senior Director, Clinical Development )
Study ID Numbers:	CS0777-A-U102, IND 77,409
First Received:	February 4, 2008
Last Updated:	October 29, 2008
ClinicalTrials.gov Identifier:	NCT00616733
Health Authority:	United States: Food and Drug Administration