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A Study to Determine the Efficacy and Safety of Fasinumab for the Treatment of Adults With Chronic Low Back Pain

Low Back Pain Clinical Trial

Official title:
A Randomized, Double-blind, Multi-dose, Placebo-controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate to Severe Chronic Low Back Pain

Clinical Trial Summary

The main objective of the trial is to evaluate the efficacy of fasinumab compared to placebo as measured by the change from baseline in the average daily Low Back Pain Intensity (LBPI) Numerical Rating Scale (NRS).

Secondary objectives of the study are to evaluate the efficacy of fasinumab compared to placebo as measured by:

- Change from baseline in the Roland Morris disability questionnaire (RMDQ) total score

- Change from baseline in the Patient Global Assessment (PGA) of Low Back Pain (LBP) score

- Change from baseline in the average daily LBPI NRS score

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02620020
Study type Interventional
Source Regeneron Pharmaceuticals
Contact
Status Completed
Phase Phase 2/Phase 3
Start date January 26, 2016
Completion date September 13, 2017
View Details
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