Clinical trial NCT05086289: Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Chronic Low Back Pain
Official title: Randomized Placebo-controlled Phase 2 Clinical Trial to Evaluate LY3526318 for the Treatment of Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Low-back Pain
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2021-10-20
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Change From Baseline for Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) at Week 4
timeFrame: Baseline, Week 4
Secondary outcomes:
measure: Change From Baseline for Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
timeFrame: Baseline, Week 8
measure: Change From Baseline on the Roland Morris Disability Questionnaire (RMDQ)
timeFrame: Baseline, Week 4
measure: Change From Baseline on the Roland Morris Disability Questionnaire (RMDQ)
timeFrame: Baseline, Week 8
measure: Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change
timeFrame: Baseline, Week 4
measure: Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change
timeFrame: Baseline, Week 8
measure: Change From Baseline for Worst Pain Intensity as Measured by NRS
timeFrame: Baseline, Week 4
measure: Change From Baseline for Worst Pain Intensity as Measured by NRS
timeFrame: Baseline, Week 8
measure: Change From Baseline on the Visual Analog Scale (VAS) for Pain
timeFrame: Baseline, Week 4
measure: Change From Baseline on the Visual Analog Scale (VAS) for Pain
timeFrame: Baseline, Week 8
measure: Change From Baseline on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep
timeFrame: Baseline, Week 4
measure: Change From Baseline on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep
timeFrame: Baseline, Week 8
measure: Change From Baseline on the EuroQuality of Life Five Dimensions (5D) Five Level (5L) Questionnaire (EQ-5D-5L) Health State Index (United States Algorithm)
timeFrame: Baseline, Week 4
measure: Change From Baseline on the EuroQuality of Life Five Dimensions (5D) Five Level (5L) Questionnaire (EQ-5D-5L) Health State Index (United States Algorithm)
timeFrame: Baseline, Week 8
measure: Total Amount of Rescue Medication Use as Measured by Average Daily Dosage
timeFrame: Week 4
measure: Total Amount of Rescue Medication Use as Measured by Average Daily Dosage
timeFrame: Week 8
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Synexus- Chandler
state: Arizona
city: Glendale
country: United States
facility: Synexus Clinical Research - Glendale
state: Arizona
city: Tempe
country: United States
facility: Alliance for Multispecialty Research, LLC Tempe
state: Arizona
city: Riverside
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Hamden
country: United States
facility: CMR of Greater New Haven
state: Connecticut
city: Aventura
country: United States
facility: VIN-Julie Schwartzbard
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: Synexus Clinical Research US, Inc - Orlando
state: Florida
city: Pinellas Park
country: United States
facility: Synexus Clinical Research US, Inc.
state: Florida
city: The Villages
country: United States
facility: Synexus Clinical Research US, Inc.
state: Florida
city: Idaho Falls
country: United States
facility: Rocky Mountain Clinical Research
state: Idaho
city: Chicago
country: United States
facility: Synexus Clinical Research US, Inc.
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Methuen
country: United States
facility: ActivMed Practices and Research
state: Massachusetts
city: Waltham
country: United States
facility: MedVadis Research Corporation
state: Massachusetts
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: Saint Peters
country: United States
facility: StudyMetrix Research
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research LLC
state: Missouri
city: Cincinnati
country: United States
facility: Synexus - Cincinnati
state: Ohio
city: Dayton
country: United States
facility: META Medical Research Institute
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Austin
country: United States
facility: FutureSearch Trials
state: Texas
city: San Antonio
country: United States
facility: Synexus - US
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
city: Ponce
country: Puerto Rico
facility: Ponce Medical School Foundation Inc.
city: San Juan
country: Puerto Rico
facility: Latin Clinical Trial Center
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: