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Completed

NCT Number: NCT00616733

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

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

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Denver, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CS-0777 tablets

Drug

0.1 mg, once-weekly, for 12 weeks

Primary outcomes

  1. Safety and tolerability.

    Time frame: 12 weeks, with 4 weeks to follow-up

Secondary outcomes

  1. Pharmacodynamic response (lymphocyte counts Pharmacokinetics Exploratory efficacy based on brain MRI lesions)

    Time frame: 12 weeks, with 4 weeks to follow up.

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 15, 2008
Registry last updated
Mar 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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