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

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

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

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: CS-0777 tablets; Drug: CS-0777 tablets; Drug: CS-0777 tablets

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States
  • Florida
    • Port Orange, Florida, United States
  • Kansas
    • Lenexa, Kansas, United States
  • Montana
    • Billings, Montana, United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: CS-0777 tablets; 0.1 mg, once-weekly, for 12 weeks; Drug: CS-0777 tablets; 0.3 mg, once-weekly or once every 2 weeks, for 12 weeks; Drug: CS-0777 tablets; 0.6 mg, once-weekly or once every 2 weeks, for 12 weeks
Experimental: 2	Drug: CS-0777 tablets; 0.1 mg, once-weekly, for 12 weeks; Drug: CS-0777 tablets; 0.3 mg, once-weekly or once every 2 weeks, for 12 weeks; Drug: CS-0777 tablets; 0.6 mg, once-weekly or once every 2 weeks, for 12 weeks
Experimental: 3	Drug: CS-0777 tablets; 0.1 mg, once-weekly, for 12 weeks; Drug: CS-0777 tablets; 0.3 mg, once-weekly or once every 2 weeks, for 12 weeks; Drug: CS-0777 tablets; 0.6 mg, once-weekly or once every 2 weeks, for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability.	12 weeks, with 4 weeks to follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacodynamic response (lymphocyte counts Pharmacokinetics Exploratory efficacy based on brain MRI lesions)	12 weeks, with 4 weeks to follow up.

Collaborators and Investigators

• Sponsor: Daiichi Sankyo, Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: February 4, 2008
• First Submitted That Met QC Criteria: February 4, 2008
• First Posted (Estimate): February 15, 2008

Study Record Updates

• Last Update Posted (Estimate): March 10, 2011
• Last Update Submitted That Met QC Criteria: March 9, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Multiple sclerosis, relapsing, secondary progressive, clinically isolated syndrome, MRI
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: CS0777-A-U102; IND 77,409