drugset / Trial / NCT00991172
A Study to Evaluate the Safety and Efficacy of Subcutaneously Administered REGN475(SAR164877) in Patients With Sciatic Pain
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fasinumab | Monoclonal antibody | — | Subcutaneous |