drugset
drugset / Trial / NCT01240876

Study to Evaluate the Safety and Efficacy of Placulumab (CEP-37247) Administered by the Transforaminal Epidural Route for the Treatment of Patients With Lumbosacral Radicular Pain Associated With Disk Herniation

NCT01240876 ↗

Phase 1/2 Completed 98 enrolled Cephalon
RandomizedParallel-groupTriple-blindTreatment

Summary

The primary objective of the study is to evaluate the safety and efficacy of CEP-37247 compared with placebo as assessed by the occurrence of adverse events, and the mean change in average pain intensity (API) in the affected leg.

Timeline

Start
2011-01
Primary completion
2013-03
Completion
2013-04

Drugs

EvaluationDrugModalityDoseRoute
Subject PLACULUMAB Protein / enzyme biologic 0.5 mg Other
Subject PLACULUMAB Protein / enzyme biologic 1 mg Other
Subject PLACULUMAB Protein / enzyme biologic 3 mg Other
Subject PLACULUMAB Protein / enzyme biologic 6 mg Other
Subject PLACULUMAB Protein / enzyme biologic 12 mg Other

Indications

sciatica