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Study of the Safety, Tolerability, Pharmacokinetics and Safety of BG00010 (Neublastin) in Subjects With Sciatica.

Sciatica Clinical Trial

Official title:
Phase 1: A Multi-Centered, Randomized, Blinded, Placebo-Controlled, Serial-Cohort, Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of BG00010 (Neublastin) in Subjects With Sciatica

Clinical Trial Summary

The primary objective of the study is to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of 3 intravenous (IV) injections of BG00010 given on 2 fixed schedules; weekly and as frequently as every 48 hours (but no more than 3 times per week).

Secondary objectives of this study in this study population are to explore the repeated-dose immunogenicity of BG00010 and to explore the potential of BG00010 to reduce pain following multiple-dose administration.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01405833
Study type Interventional
Source Biogen
Contact
Status Completed
Phase Phase 1
Start date July 2011
Completion date September 2012
View Details
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