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

• Sponsor: Daiichi Sankyo, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00616733
• Collaborator: (none)
• Enrollment: 25
• Locations: 5
• Arms: 3
• Duration (Months): 30
• Patients Per Site: 5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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; Drug: CS-0777 tablets; Drug: CS-0777 tablets	Phase 1

Study Design

• Study Type: Interventional
• 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: Mar 1, 2008
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Sep 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Safety and tolerability. [12 weeks, with 4 weeks to follow-up]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Denver	Colorado	United States
2		Port Orange	Florida	United States
3		Lenexa	Kansas	United States
4		Billings	Montana	United States
5		Philadelphia	Pennsylvania	United States

Sponsors and Collaborators

• Daiichi Sankyo, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00616733
• Other Study ID Numbers: CS0777-A-U102; IND 77,409
• First Posted: Feb 15, 2008
• Last Update Posted: Mar 10, 2011
• Last Verified: Mar 1, 2011

• Keywords provided by , ,: Multiple sclerosis, relapsing, secondary progressive, clinically isolated syndrome, MRI
• Additional relevant MeSH terms: Multiple Sclerosis; Sclerosis

Study Results

No Results Posted as of Mar 10, 2011