Status:
WITHDRAWN
Dose Escalation Study to Evaluate the Penetration and Pharmacodynamic Effects of Baminercept in the Cerebrospinal Fluid (CSF)and Safety in Subjects With Secondary Progressive Multiple Sclerosis (SPMS)
Lead Sponsor:
Biogen
Conditions:
Secondary Progressive Multiple Sclerosis
Eligibility:
All Genders
18-57 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a prospective, randomized, multicenter, dose escalation study to determine subject safety, pharmacokinetic, and pharmacodynamic responses in patients with SPMS
Detailed Description
This study is a prospective, randomized, placebo-controlled, blinded, dose escalation study of 3 to 4 cohorts with defined number of patients per cohort receiving active drug or placebo for a period o...
Eligibility Criteria
Inclusion
- A diagnosis of Secondary Progressive Multiple Sclerosis
- Aged 18 to 57 years old, at the time of informed consent
Exclusion
- History of clinically important (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, immune, psychiatric, hepatic, renal or hematologic insufficiency or any other major disease other than MS ( Multiple Sclerosis)
- Inability in the opinion of the Investigator to comply with study requirements
- Other protocol-defined criteria may apply
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01181089
Start Date
September 1 2010
Last Update
September 16 2013
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