A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Diabetic Peripheral Neuropathic Pain (NP05)

Chronic Pain Clinical Trial

Official title:

A Master Protocol for Randomized, Placebo-Controlled, Phase 2 Clinical Trials of Multiple Interventions for the Treatment of Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05620576
• Other study ID #: 18340
• Secondary ID: H0P-MC-NP05
• Status: Completed
• Phase: Phase 2
• Start date: November 14, 2022
• Est. completion date: August 1, 2023

Study information

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

Clinical Trial Summary

This study is being done to test the safety and efficacy of the study drug LY3857210 for the treatment of diabetic peripheral neuropathic pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: August 1, 2023
• Est. primary completion date: July 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males and females may participate in this trial.
• No male contraception is required except in compliance with specific local government study requirements.
• Women of child bearing potential (WOCBP) and women not of child bearing potential (WNOCBP) may participate in this trial.
• Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

• Have a seizure disorder, history of seizure (other than remote history of childhood febrile seizure), or a condition that would place the participant at increased risk of seizure, such as head injury (for example, skull fracture, cerebral contusion, concussion, or trauma resulting in prolonged unconsciousness), intracranial neoplasm or hemorrhage.
• Have an eGFR of <30 mL/min/1.73 m2, based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula at Day 1 or Day 2.
• evidence of Hepatitis B virus or Hepatitis C virus.
• Women who are pregnant or breastfeeding.

Related Conditions & MeSH terms

• Chronic Pain
• Diabetic Neuropathies
• Diabetic Peripheral Neuropathic Pain
• Diabetic Peripheral Neuropathy
• Neuralgia
• Peripheral Nervous System Diseases

Intervention

Drug:
• LY3857210
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 of Neurology	Austin	Texas
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	Synexus Clinical Research US, Inc.	Chandler	Arizona
United States	Northwestern University	Chicago	Illinois
United States	META Medical Research Institute	Dayton	Ohio
United States	Accel Research Sites- Clinical Research Unit	DeLand	Florida
United States	Altoona center for clinical research	Duncansville	Pennsylvania
United States	Lillestol Research	Fargo	North Dakota
United States	CMR of Greater New Haven, LLC	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 Clinical Research - St. Petersburg	San Antonio	Texas
United States	Artemis Institute for Clinical Research	San Diego	California
United States	Clinvest Headlands Llc	Springfield	Missouri
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)		Baseline, Up to Week 8
Secondary	Change from Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Total Interference Score		Baseline, Up to Week 8
Secondary	Change from Baseline for Overall Improvement as Measured by Patient's Global Impression of Change		Baseline, Up to Week 8
Secondary	Change from Baseline for Worst Pain Intensity as Measured by NRS		Baseline, Up to Week 8
Secondary	Change from Baseline on the Visual Analog Scale (VAS) for Pain		Baseline, Up to Week 8
Secondary	Change from Baseline on the Sleep Scale from the Medical Outcomes Study (MOS Sleep Scale)		Baseline, Up to Week 8
Secondary	Change from Baseline on the EuroQol-5D 5 Level Questionnaire (EQ-5D-5L)		Baseline, Up to Week 8

External Links

•   A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Diabetic Peripheral Neuropathic Pain (NP05)