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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)

Secondary Progressive Multiple Sclerosis Clinical Trial

Official title:
A Multicenter, Randomized, Blinded, Placebo-Controlled, 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

Clinical Trial Summary

This is a prospective, randomized, multicenter, dose escalation study to determine subject safety, pharmacokinetic, and pharmacodynamic responses in patients with SPMS

Clinical Trial 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 of 4 months followed by safety monitoring for an additional 4 months after the last dose ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01181089
Study type Interventional
Source Biogen
Contact
Status Withdrawn
Phase Phase 1/Phase 2
Start date September 2010
View Details
See also
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