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

Tracking Information

First Received Date ^ICMJE

February 4, 2008

Last Updated Date

September 14, 2009

Start Date ^ICMJE

March 2008

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00616733 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment

Condition ^ICMJE

Multiple Sclerosis

Intervention ^ICMJE

Drug: CS-0777 tablets

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Sharon Herbert, PhD

S.Herbert@Medpace.com

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00616733

Responsible Party

James Moberly, PhD, Senior Director, Clinical Development, Daiichi Sankyo, Inc.

Study ID Numbers ^ICMJE

CS0777-A-U102, IND 77,409

Study Sponsor ^ICMJE

Daiichi Sankyo Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Information Provided By

Daiichi Sankyo Inc.

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP