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

Daiichi Sankyo logo

Daiichi Sankyo

Status and phase

Completed
Phase 1

Conditions

Multiple Sclerosis

Treatments

Drug: CS-0777 tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT00616733
CS0777-A-U102
IND 77,409

Details and patient eligibility

About

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

Enrollment

25 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

25 participants in 3 patient groups

1
Experimental group
Treatment:
Drug: CS-0777 tablets
2
Experimental group
Treatment:
Drug: CS-0777 tablets
3
Experimental group
Treatment:
Drug: CS-0777 tablets

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems