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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Low Back Pain

In brief

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

Key facts

Study ID

NCT02620020

Run by

Regeneron Pharmaceuticals

People needed

563

Starts

2016-01-26

Expected to finish

2017-09-13

Last updated by the study team

2020-06-16

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Study site — Chandler, Arizona, United States
• Study site — Glendale, Arizona, United States
• Study site — Mesa, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Beverly Hills, California, United States
• Study site — Carlsbad, California, United States
• Study site — Lakewood, California, United States
• Study site — Long Beach, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — Santa Rosa, California, United States
• Study site — Vista, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Littleton, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Clearwater, Florida, United States
• Study site — Fort Myers, Florida, United States
• Study site — Leesburg, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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