Phase 3
Completed N=563
A Study to Determine the Efficacy and Safety of Fasinumab for the Treatment of Adults With Chronic Low Back Pain
Source: ClinicalTrials.gov NCT02620020 ↗Enrolled (actual)
563
Serious AEs
2.5%
Results posted
Aug 2019
Primary outcomePrimary: Change From Baseline to Week 16 in the Average Daily Low Back Pain Index Numeric Rating Scale (LBPI NRS) Score — -1.7; -2.0; -2.5; -2.4 Scores on a scale — p=0.3876
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 16 in the Average Daily Low Back Pain Index Numeric Rating Scale (LBPI NRS) Score |
-1.7; -2.0; -2.5; -2.4 | 0.3876 |
| SECONDARY Change From Baseline to Weeks 2, 4, 8, and 12 in the Average Low Back Pain Index Numeric Rating Scale Score (LBPI NRS) |
-0.9; -1.3; -1.6; -1.6; -0.9; -1.5 | — |
| SECONDARY Change From Baseline to Week 16 in Roland Morris Disability Questionnaire (RMDQ) Total Score |
-3.8; -6.0; -5.8; -6.3 | 0.0028 sig |
| SECONDARY Change From Baseline to Week 16 in the Patient Global Assessment (PGA) of Low Back Pain (LBP) Score |
-0.7; -0.9; -0.8; -1.0 | 0.1501 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02620020). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.