Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy (DPN)

Diabetic Peripheral Neuropathic Pain Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04146896
• Other study ID #: NYX-2925-2008
• Status: Completed
• Phase: Phase 2
• Start date: November 12, 2019
• Est. completion date: February 23, 2022

Study information

• Verified date: April 2023
• Source: Aptinyx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy of NYX-2925 versus placebo in treating the neuropathic pain associated with diabetic peripheral neuropathy.

Description:

This is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of NYX-2925 in subjects with neuropathic pain associated with diabetic peripheral neuropathy. The study will be a 13- to 16-week study, including a 1- to 4-week Screening Period, followed by a 12- week double-blind, randomized, placebo-controlled Treatment Period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: February 23, 2022
• Est. primary completion date: February 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion criteria:

• Informed consent
• Subject has diabetic peripheral neuropathy of symmetrical nature in lower extremities for =4 years and reports at least moderate pain over the last week
• Stable diabetic and protocol allowed medication during the study
• Agrees to use highly effective birth control during the study
• Has not participated in an interventional study for at least 30 days and agrees not to participate in another interventional study during the study

Exclusion Criteria:

• Pain due to other conditions or diseases that would complicate participation in the study or pain reporting
• Current or historical serious medical conditions
• Prior participation in NYX-2925 clinical trial

Related Conditions & MeSH terms

• Diabetic Peripheral Neuropathic Pain
• Neuralgia
• Peripheral Nervous System Diseases

Intervention

Drug:
• NYX-2925 50 mg
NYX-2925 administered orally
• Placebo
Placebo administered orally

Locations

Country	Name	City	State
United States	Aptinyx Clinical Site	Blackfoot	Idaho
United States	Aptinyx Clinical Site	Brandon	Florida
United States	Aptinyx Clinical Site	Brooklyn	New York
United States	Aptinyx Clinical Site	Clearwater	Florida
United States	Aptinyx Clinical Site	Decatur	Georgia
United States	Aptinyx Clinical Site	Duncansville	Pennsylvania
United States	Aptinyx Clinical Site	Flossmoor	Illinois
United States	Aptinyx Clinical Site	Fresno	California
United States	Aptinyx Clinical Site	Greenacres City	Florida
United States	Aptinyx Clinical Site	Greenville	North Carolina
United States	Aptinyx Clinical Site	Hazelwood	Missouri
United States	Aptinyx Clinical Site	Houston	Texas
United States	Aptinyx Clinical Site	Irvine	California
United States	Aptinyx Clinical Site	Las Vegas	Nevada
United States	Aptinyx Clinical Site	Lomita	California
United States	Aptinyx Clinical Site	Los Angeles	California
United States	Aptinyx Clinical Site	Marietta	Georgia
United States	Aptinyx Clinical Site	Mesquite	Texas
United States	Aptinyx Clinical Site	Miami	Florida
United States	Aptinyx Clinical Site	Miami	Florida
United States	Aptinyx Clinical Site	New Port Richey	Florida
United States	Aptinyx Clinical Site	New York	New York
United States	Aptinyx Clinical Site	Norco	California
United States	Aptinyx Clinical Site	Plano	Texas
United States	Aptinyx Clinical Site	Pomona	California
United States	Aptinyx Clinical Site	Rochester	New York
United States	Aptinyx Clinical Site	Rochester	Michigan
United States	Aptinyx Clinical Site	San Antonio	Texas
United States	Aptinyx Clinical Site	Santa Ana	California
United States	Aptinyx Clinical Site	Tampa	Florida
United States	Aptinyx Clinical Site	Tampa	Florida
United States	Aptinyx Clinical Site	Tustin	California
United States	Aptinyx Clinical Site	Winston-Salem	North Carolina
United States	Aptinyx Clinical Site	Winter Haven	Florida
United States	Aptinyx Clinical Site	Winter Park	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Aptinyx	Worldwide Clinical Trials

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity Numeric Rating Scale (NRS) Score	Change from baseline in the weekly mean of the daily Numeric Rating Scale (NRS) score assessing average pain intensity related to DPN in the past 24 hours. In the NRS, a participant selects a whole number (0 to 10) that best indicates the intensity of his/her pain, where 0 represents no pain and 10 represents worst pain imaginable.	Week 12
Secondary	Daily Sleep Interference Scale (DSIS) Score	Change from baseline in the weekly mean of the Daily Sleep Interference Scale (DSIS) scores. The DSIS asks participants to ''Select the number that best describes how much your pain has interfered with your sleep during the past 24 hours.'' Response options for the DSIS range from 0 (did not interfere with sleep) to 10 (completely interfered with sleep/unable to sleep due to pain).	Week 12
Secondary	Patient Global Impression of Change (PGI-C)	Number of subjects 'much improved' or 'very much improved' on Patient Global Impression of Change (PGI-C)	Week 12
Secondary	Number of Subjects Achieving =30% Pain Reduction	Number of subjects achieving =30% pain reduction from baseline in the weekly mean NRS average pain intensity related to DPN	Week 12
Secondary	Number of Subjects Achieving =50% Reduction	Number of subjects achieving =50% reduction from baseline in the weekly mean NRS average pain intensity related to DPN	Week 12
Secondary	Norfolk Quality of Life Questionnaire - Diabetic Neuropathy (QOL-DN) Score	Change from baseline in the Norfolk Quality of Life Questionnaire - Diabetic Neuropathy (QOL-DN) score. The QOL-DN is a 47 item subject reported questionnaire. Scores range from 0-126, and lower scores indicate improved quality of life.	Week 12
Secondary	Use of Rescue Medication	Number of subjects using rescue medication	Week 12