Skip to main content
MedPathMedPath Home
Clinical Trials/NCT00616733
NCT00616733
Completed
Phase 1

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

Daiichi Sankyo0 sites25 target enrollmentMarch 2008
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsMultiple Sclerosis
InterventionsCS-0777 tablets
DrugsCS-0777 tablets

Overview

Phase
Phase 1
Intervention
CS-0777 tablets
Conditions
Multiple Sclerosis
Sponsor
Daiichi Sankyo
Enrollment
25
Primary Endpoint
Safety and tolerability.
Status
Completed
Last Updated
15 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2008
End Date
September 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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

Arms & Interventions

1

Intervention: CS-0777 tablets

2

Intervention: CS-0777 tablets

3

Intervention: CS-0777 tablets

Outcomes

Primary Outcomes

Safety and tolerability.

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

Secondary Outcomes

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

Similar Trials

Completed
Phase 1
Safety,Tolerability and MTD KA2507 (HDAC6 Inhibitor) in Patients With Solid TumoursSolid Tumor, Adult
NCT03008018Karus Therapeutics Limited20
Terminated
Phase 2
A Dose Escalation Study of TCD601 Compared to ATG in de Novo Renal TransplantationKidney Transplantation
NCT06365437ITB-Med LLC33
Completed
Phase 2
A Dose Escalation Study in de Novo Renal TransplantationKidney Transplantation
NCT04311632ITB-Med LLC13
Completed
Phase 1
An Open-label Safety, Tolerability, and Dose-range Finding Study of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy (SMA)Spinal Muscular Atrophy
NCT01494701Biogen28
Unknown
Phase 1
Phase I Trial to Investigate Cafusertib Hydrochloride Monotherapy in Chinese Patients With Advanced Solid TumoursNeoplasms
NCT02314884Jiangsu Hansoh Pharmaceutical Co., Ltd.40