Skip to main content
OpenTrials
Completed

NCT Number: NCT02620020

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

London, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Male or female ≥35 years of age at the screening visit
  • Clinical diagnosis of chronic moderate to severe LBP (nonradiculopathic)for ≥3 months
  • History of regular analgesic medication
  • History of inadequate pain relief or intolerance to analgesics used for chronic LBP
  • Willing to discontinue current pain medication

Key Exclusion Criteria:

  • History of lumbosacral radiculopathy within the past 2 years
  • Evidence on baseline lumbar spine magnetic resonance imaging of potentially confounding conditions
  • Recent use of longer acting pain medications
  • Evidence of destructive arthropathy
  • Other medical conditions that may interfere with participation or accurate assessments during the trial

Treatment and study plan

Fasinumab

Drug

Participants received fasinumab SC or IV, Q4W or Q8W.

Other names: REGN475

Placebo

Drug

Participants received placebo matching to fasinumab SC or IV, Q4W or Q8W.

Primary outcomes

  1. Change From Baseline to Week 16 in the Average Daily Low Back Pain Index Numeric Rating Scale (LBPI NRS) Score

    Time frame: Baseline to Week 16

    Average daily low back pain (LBP) was assessed on an 11-point numeric rating scale (NRS) and was defined as the average of the non-missing daily LBPI NRS scores for the 7 days before and including nominal visit. Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain.

Secondary outcomes

  1. Change From Baseline to Weeks 2, 4, 8, and 12 in the Average Low Back Pain Index Numeric Rating Scale Score (LBPI NRS)

    Time frame: Baseline to Weeks 2, 4, 8, and 12

    Average daily low back pain (LBP) was assessed on an 11-point numeric rating scale (NRS) and was defined as the average of the non-missing daily LBPI NRS scores for the 7 days before and including nominal visit. Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain.

  2. Change From Baseline to Week 16 in Roland Morris Disability Questionnaire (RMDQ) Total Score

    Time frame: Baseline to Week 16

    The RMDQ is a self-administered, widely used health status measure for lower back pain (LBP). It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. The score of the RMDQ is the total number of items checked - that is from a minimum of 0 (no disability) to a maximum of 24 (maximum disability), where lower scores indicative of better function.

  3. Change From Baseline to Week 16 in the Patient Global Assessment (PGA) of Low Back Pain (LBP) Score

    Time frame: Baseline to Week 16

    The PGA of LBP is a participant assessed 5 point Likert scale of LBP ranging from 0-5 where 1=very well; 2=well; 3=fair; 4=poor; and 5=very poor.

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 2, 2015
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.