Phase 2
N=159
Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Chronic Low Back Pain
Chronic Low-back Pain
Bottom Line
View on ClinicalTrials.gov: NCT05086289 ↗Enrolled (actual)
159
Serious AEs
0.7%
Results posted
Oct 2023
Primary outcome: Primary: Change From Baseline for Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) at Week 4 — -1.28; -0.90 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LY3526318 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline for Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) at Week 4 |
-1.28; -0.90 | — |
| SECONDARY Change From Baseline for Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) |
-1.47; -1.20 | — |
| SECONDARY Change From Baseline on the Roland Morris Disability Questionnaire (RMDQ) |
-2.55; -1.37 | — |
| SECONDARY Change From Baseline on the Roland Morris Disability Questionnaire (RMDQ) |
-2.55; -1.37 | — |
| SECONDARY Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change |
3.00; 3.26 | — |
| SECONDARY Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change |
3.00; 3.26 | — |
| SECONDARY Change From Baseline for Worst Pain Intensity as Measured by NRS |
-1.69; -1.18 | — |
| SECONDARY Change From Baseline for Worst Pain Intensity as Measured by NRS |
-1.69; -1.18 | — |
| SECONDARY Change From Baseline on the Visual Analog Scale (VAS) for Pain |
-19.50; -14.72 | — |
| SECONDARY Change From Baseline on the Visual Analog Scale (VAS) for Pain |
-19.50; -14.72 | — |
| SECONDARY Change From Baseline on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep |
5.04; 3.52 | — |
| SECONDARY Change From Baseline on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep |
5.04; 3.52 | — |
| SECONDARY Change From Baseline on the EuroQuality of Life Five Dimensions (5D) Five Level (5L) Questionnaire (EQ-5D-5L) Health State Index (United States Algorithm) |
0.05; 0.03 | — |
| SECONDARY Change From Baseline on the EuroQuality of Life Five Dimensions (5D) Five Level (5L) Questionnaire (EQ-5D-5L) Health State Index (United States Algorithm) |
0.05; 0.03 | — |
| SECONDARY Total Amount of Rescue Medication Use as Measured by Average Daily Dosage |
237.79; 228.06 | — |
| SECONDARY Total Amount of Rescue Medication Use as Measured by Average Daily Dosage |
237.79; 228.06 | — |
Summary
The purpose of this study is to test whether LY3526318 is efficacious and safe in relieving chronic low back pain (CLBP). 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 <95 during screening.
- Have a history of daily pain for at least 12 weeks based on participant report or medical history.
- Have a body mass index <40 kilograms per meter squared (kg/m²) (inclusive).
- Are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and will not start any new nonpharmacologic pain-relieving therapies during study participation.
- Are willing to discontinue all medications taken for chronic pain conditions for the duration of the study.
- Are at 18 years old or older at the time consent is signed.
- Have a history of low back pain for at least 3 months located between the 12th thoracic vertebra and the lower gluteal folds, with or without radiation.
- Have a history of low back pain as classified by the Quebec Task Force Category 1 through 3.
- Are men, or women able to abide by reproductive and contraceptive requirements.
Exclusion Criteria
- Have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest (for example, ablation techniques).
- Have surgery planned during the study for any reason, related or not to the disease state under evaluation.
- Have, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation.
- Have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
- Have fibromyalgia
- Have a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association).
- 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 a spinal cord stimulator or dorsal root ganglion stimulator.
- Are pregnant or breastfeeding.
Data sourced from ClinicalTrials.gov (NCT05086289). 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.