Phase 2
N=149
Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Chronic Low Back Pain
Chronic Low-back Pain
Bottom Line
View on ClinicalTrials.gov: NCT04529096 ↗Enrolled (actual)
149
Serious AEs
5.4%
Results posted
Jun 2022
Primary outcome: Primary: Change From Baseline for Average Pain Intensity as Measured by the NRS — -1.57; -2.09 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LY3016859 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline for Average Pain Intensity as Measured by the NRS |
-1.57; -2.09 | — |
| SECONDARY Change From Baseline on the Roland Morris Disability Questionnaire (RMDQ) |
-2.36; -3.40 | — |
| SECONDARY Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change (PGI) |
2.93; 2.77 | — |
| SECONDARY Change From Baseline for Worst Pain Intensity as Measured by NRS |
-1.72; -2.20 | — |
| SECONDARY Change From Baseline on the Visual Analog Scale (VAS) for Pain |
-18.68; -23.31 | — |
| SECONDARY Change From Baseline Assessment to Endpoint on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) |
-0.02; -0.08 | — |
| SECONDARY Total Amount of Rescue Medication Use as Measured by Average Dosage Per Week |
312.51; 327.69 | — |
| SECONDARY Change From Baseline on the EuroQol-5D 5 Level Questionnaire (EQ-5D-5L) (United States) |
0.03; 0.08 | — |
Summary
This study is being done to test the safety and efficacy of the study drug LY3016859 for the treatment of chronic low back pain. This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292) which is a protocol to accelerate the development of new treatments for chronic pain.
Eligibility Criteria
Inclusion Criteria
- Have a visual analog scale (VAS) pain value ≥40 and 450 milliseconds (msec) for male participants, >470 msec for female participants, or >480 msec for participants with bundle branch block.
- Have any clinically important abnormality at screening, as determined by investigator, in physical or neurological examination, vital signs, electrocardiogram (ECG), or clinical laboratory test results that could be detrimental to the participant or could compromise the study.
- Have a positive human immunodeficiency virus (HIV) test result at screening.
- Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
- Have an intolerance to acetaminophen or paracetamol or any of its excipients.
- Have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening.
- Have used a therapeutic injection (botulinum toxin or corticosteroids) in the 3 months prior to starting the washout period.
- Have history of or current compression fracture.
- Have had a recent major trauma (within 6 months of baseline).
- Have a history of low back pain as classified by the Quebec Task Force Categories 4 through 11.
- Are using spinal cord stimulator or dorsal root ganglion stimulator.
- Have fibromyalgia.
Data sourced from ClinicalTrials.gov (NCT04529096). 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.