Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Diabetic Peripheral Neuropathic Pain

Diabetic Peripheral Neuropathic Pain Clinical Trial

Official title:

Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY3526318 for the Treatment of Diabetic Peripheral Neuropathic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05177094
• Other study ID #: 17597
• Secondary ID: H0P-MC-NP02
• Status: Completed
• Phase: Phase 2
• Start date: January 26, 2022
• Est. completion date: October 13, 2022

Study information

• Verified date: November 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the safety and efficacy of study drug LY3526318 for the treatment of diabetic peripheral neuropathic pain (DPNP). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: October 13, 2022
• Est. primary completion date: October 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 pain medications taken for chronic pain conditions for the duration of the study.

• Have daily symmetrical foot pain secondary to peripheral neuropathy present for at least 6 months and as diagnosed through use of the Michigan Neuropathy Screening Instrument Part B =3 (©University of Michigan).

• Have a history and current diagnosis of type 1 or type 2 diabetes mellitus.

• Have stable glycemic control as indicated by a glycated hemoglobin =11 at time of screening.

• 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 product 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 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 a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association).

• Have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.

• Have fibromyalgia

• Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.

• Have a positive human immunodeficiency virus (HIV) test result at screening.

• 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 a current drug-induced neuropathy, for example, due to some types of chemotherapy, or other types of peripheral neuropathy.

• Have known hereditary motor, sensory or autonomic neuropathies.

• Are pregnant or breastfeeding.

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathic Pain
• Neuralgia

Intervention

Drug:
• LY3526318
Administered orally
• Placebo
Administered orally

Locations

Country	Name	City	State
Puerto Rico	Ponce Medical School Foundation Inc.	Ponce
Puerto Rico	Latin Clinical Trial Center	San Juan
United States	FutureSearch Trials	Austin	Texas
United States	VIN-Julie Schwartzbard	Aventura	Florida
United States	Great Lakes Research Group, Inc.	Bay City	Michigan
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Boston Clinical Trials	Boston	Massachusetts
United States	Joslin Diabetes Center	Boston	Massachusetts
United States	Synexus Clinical Research US, Inc.	Chandler	Arizona
United States	Northwestern University	Chicago	Illinois
United States	Synexus Clinical Research US, Inc.	Chicago	Illinois
United States	Synexus - Cincinnati	Cincinnati	Ohio
United States	Cedar Health Research	Dallas	Texas
United States	META Medical Research Institute	Dayton	Ohio
United States	Altoona Center For Clinical Research	Duncansville	Pennsylvania
United States	Synexus Clinical Research - Glendale	Glendale	Arizona
United States	CMR of Greater New Haven	Hamden	Connecticut
United States	Rocky Mountain Clinical Research	Idaho Falls	Idaho
United States	ActivMed Practices and Research	Methuen	Massachusetts
United States	New Horizon Research Center	Miami	Florida
United States	Suncoast Research Group	Miami	Florida
United States	University of Miami Don Suffer Clinical Research Building	Miami	Florida
United States	Renstar Medical Research	Ocala	Florida
United States	Synexus Clinical Research US, Inc - Orlando	Orlando	Florida
United States	Arizona Research Center	Phoenix	Arizona
United States	Synexus Clinical Research US, Inc.	Pinellas Park	Florida
United States	Rainier Clinical Research Center	Renton	Washington
United States	Artemis Institute for Clinical Research	Riverside	California
United States	StudyMetrix Research	Saint Peters	Missouri
United States	Synexus - US	San Antonio	Texas
United States	Artemis Institute for Clinical Research	San Diego	California
United States	NorthShore University HealthSystem	Skokie	Illinois
United States	Clinvest Research LLC	Springfield	Missouri
United States	Alliance for Multispecialty Research, LLC Tempe	Tempe	Arizona
United States	Synexus Clinical Research US, Inc - Orlando	The Villages	Florida
United States	MedVadis Research Corporation	Waltham	Massachusetts
United States	North Georgia Clinical Research	Woodstock	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)	The NRS was used to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Posterior mean change from baseline, 95 percent (%) credible intervals was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.	Baseline, Week 4
Primary	Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)	The NRS was used to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Posterior mean change from baseline, 95% credible intervals was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.	Baseline, Week 8
Secondary	Change From Baseline in the Brief Pain Inventory-Short Form Modified (BPI-SFM) Total Pain Interference Score	The BPI-SFM is a numeric rating scale that assesses the severity of pain (severity scale) and its impact on daily functioning (Pain Interference scale). BPI-SFM pain interference scale has been reported here. Pain interference scale has 7 items, including general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life each assessed on a 10-point scale. All the 7-items are averaged to produce a total score ranging from 0 to 10 where, 0=does not interfere to 10=completely interferes and the mean is reported here. Higher score represents worse outcome. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.	Baseline, Week 4
Secondary	Change From Baseline in the Brief Pain Inventory-Short Form Modified (BPI-SFM) Total Pain Interference Score	The BPI-SFM is a numeric rating scale that assesses the severity of pain (severity scale) and its impact on daily functioning (Pain Interference scale). BPI-SFM pain interference scale has been reported here. Pain interference scale has 7 items, including general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life each assessed on a 10-point scale. All the 7-items are averaged to produce a total score ranging from 0 to 10 where, 0=does not interfere to 10=completely interferes and the mean is reported here. Higher score represents worse outcome. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.	Baseline, Week 8
Secondary	Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change	Patients Global Impression of change captured the participant's perspective of treatment apart from sub-aspects of the general improvement. This is a numeric scale from 1 to 7: 1=very much better, and 7=very much worse. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.	Baseline, Week 4
Secondary	Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change	Patients Global Impression of change captured the participant's perspective of treatment apart from sub-aspects of the general improvement. This is a numeric scale from 1 to 7: 1=very much better, and 7=very much worse. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.	Baseline, Week 8
Secondary	Change From Baseline for Worst Pain Intensity as Measured by NRS	The NRS was used to describe pain severity. Participants were asked to describe their worst pain over the past 24 hours, on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.	Baseline, Week 4
Secondary	Change From Baseline for Worst Pain Intensity as Measured by NRS	The NRS was used to describe pain severity. Participants were asked to describe their worst pain over the past 24 hours, on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.	Baseline, Week 8
Secondary	Change From Baseline on the Visual Analog Scale (VAS) for Pain	VAS was a graphic, single-item scale where participants were asked to describe their pain intensity over the past week, on a scale of 0 to 100: 0=no pain, and 100=worst imaginable pain. Participants completed the VAS by placing a line perpendicular to the VAS line at a point that described their pain intensity. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.	Baseline, Week 4
Secondary	Change From Baseline on the Visual Analog Scale (VAS) for Pain	VAS was a graphic, single-item scale where participants were asked to describe their pain intensity over the past week, on a scale of 0 to 100: 0=no pain, and 100=worst imaginable pain. Participants completed the VAS by placing a line perpendicular to the VAS line at a point that described their pain intensity. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.	Baseline, Week 8
Secondary	Change From Baseline on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep	The MOS Sleep Scale consists of 12 questions addressing the past week. Question 1 asks time to fall asleep and it is reported in 5-point timeframe categories. Question 2 asks average hours of sleep. In the remaining 10 questions participants report how often a sleep symptom or problem was present on a scale ranging from '0=all of the time' to '5=none of the time.' MOS Sleep scale dimension scores range from 0 to 100 with lower score indicating improvement, except for the dimension of sleep adequacy, where higher scores indicate improvement. Here, the average hours of sleep (i.e., Question 2) is reported as the average number of hours slept each night during the past week (range 0 to 24 hours). Higher number of hours slept indicates improvement. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.	Baseline, Week 4
Secondary	Change From Baseline on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep	The MOS Sleep Scale consists of 12 questions addressing the past week. Question 1 asks time to fall asleep and it is reported in 5-point timeframe categories. Question 2 asks average hours of sleep. In the remaining 10 questions participants report how often a sleep symptom or problem was present on a scale ranging from '0=all of the time' to '5=none of the time.' MOS Sleep scale dimension scores range from 0 to 100 with lower score indicating improvement, except for the dimension of sleep adequacy, where higher scores indicate improvement. Here, the average hours of sleep (i.e., Question 2) is reported as the average number of hours slept each night during the past week (range 0 to 24 hours). Higher number of hours slept indicates improvement. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.	Baseline, Week 8
Secondary	Total Amount of Rescue Medication Use as Measured by Average Daily Dosage	Total amount of rescue medication use as measured by average daily dosage. Posterior mean, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.	Week 4
Secondary	Total Amount of Rescue Medication Use as Measured by Average Daily Dosage	Total amount of rescue medication use as measured by average daily dosage. Posterior mean, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.	Week 8
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)	The EQ-5D-5L assessed quality of life based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant was asked to 'check the ONE box that best describes your health TODAY,' choosing from 5 options (no problems, slight problems, moderate problems, severe problems, extreme problems) provided under each dimension. The scores in the 5 dimensions were summarized into a health state index score using the United States algorithm. The health state index value is a single value on a scale from less than 0 to 1 (negative values are valued as worse than dead) with higher scores indicating better health: 0=a health state equivalent to death, and 1=perfect health.; Posterior mean change from baseline, 95% credible intervals was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.	Baseline, Week 4
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)	The EQ-5D-5L assessed quality of life based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant was asked to 'check the ONE box that best describes your health TODAY,' choosing from 5 options (no problems, slight problems, moderate problems, severe problems, extreme problems) provided under each dimension. The scores in the 5 dimensions were summarized into a health state index score using the United States algorithm. The health state index value is a single value on a scale from less than 0 to 1 (negative values are valued as worse than dead) with higher scores indicating better health: 0=a health state equivalent to death, and 1=perfect health.; Posterior mean change from baseline, 95% credible intervals was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.	Baseline, Week 8

External Links

•   Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Diabetic Peripheral Neuropathic Pain