drugset / Trial / NCT01405833

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

NCT01405833 ↗

Phase 1 Completed 56 enrolled Biogen
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2011-07
Primary completion
2012-09
Completion
2012-09

Drugs

EvaluationDrugModalityDoseRoute
Subject artemin Protein / enzyme biologic — Intravenous

Indications