12-week Safety Evaluation of Oral CS-0777 in Multiple Sclerosis Patien
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
What it found
We found no results in the registry or in papers.
This trial finished 16 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- CS-0777 tablets
What it measured
Main measures
Safety and tolerability.
12 weeks, with 4 weeks to follow-up
Safety
Other measures (1)
Pharmacodynamic response (lymphocyte counts Pharmacokinetics Exploratory efficacy based on brain MRI lesions)
12 weeks, with 4 weeks to follow up.
MRI lesionsImmune responseHow the body handles the medicine
Who could take part
Progressive MS · 18 to 65 · EDSS 0 to 6.5
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This is a 12-week study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of oral CS-0777 in patients with Multiple Sclerosis.
Papers
Loading reviews and guidelines…
History
Started
Mar 2008
Main results due
Sept 2010
Finished
Sept 2010