drugset / Trial / NCT00991172

A Study to Evaluate the Safety and Efficacy of Subcutaneously Administered REGN475(SAR164877) in Patients With Sciatic Pain

NCT00991172

Phase 2 Completed 159 enrolled Regeneron Pharmaceuticals Sanofi · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a phase 2, randomized, double-blind, parallel-group, single dose study to evaluate the safety and efficacy of 2 dose levels of REGN475 compared with placebo in patients with sciatic pain. Enrollment of approximately 50 patients in each of the 3 treatment arms is expected at up to 35 US sites, for a total enrollment of approximately 150 patients. Patients will receive 1 injection under the skin of either active or placebo REGN475, and be followed over 10 visits for 12 weeks.

Timeline

Start
2009-11
Primary completion
2010-05
Completion
2010-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Fasinumab Monoclonal antibody Subcutaneous

Indications