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

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00616733
First received: February 4, 2008
Last updated: March 9, 2011
Last verified: March 2011
  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 1

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014