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

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

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

Study Overview

• Status: Completed
• Conditions: Diabetic Peripheral Neuropathic Pain
• Intervention / Treatment: Drug: NYX-2925 50 mg; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 228
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Fresno, California, United States, 93720
      • Aptinyx Clinical Site
    • Irvine, California, United States, 92612
      • Aptinyx Clinical Site
    • Lomita, California, United States, 90717
      • Aptinyx Clinical Site
    • Los Angeles, California, United States, 90048
      • Aptinyx Clinical Site
    • Norco, California, United States, 92860
      • Aptinyx Clinical Site
    • Pomona, California, United States, 91767
      • Aptinyx Clinical Site
    • Santa Ana, California, United States, 92705
      • Aptinyx Clinical Site
    • Tustin, California, United States, 92780
      • Aptinyx Clinical Site
  • Florida
    • Brandon, Florida, United States, 33511
      • Aptinyx Clinical Site
    • Clearwater, Florida, United States, 33765
      • Aptinyx Clinical Site
    • Greenacres City, Florida, United States, 33467
      • Aptinyx Clinical Site
    • Miami, Florida, United States, 33126
      • Aptinyx Clinical Site
    • Miami, Florida, United States, 33144
      • Aptinyx Clinical Site
    • New Port Richey, Florida, United States, 34655
      • Aptinyx Clinical Site
    • Tampa, Florida, United States, 33615
      • Aptinyx Clinical Site
    • Tampa, Florida, United States, 33634
      • Aptinyx Clinical Site
    • Winter Haven, Florida, United States, 33880
      • Aptinyx Clinical Site
    • Winter Park, Florida, United States, 32789
      • Aptinyx Clinical Site
  • Georgia
    • Decatur, Georgia, United States, 30030
      • Aptinyx Clinical Site
    • Marietta, Georgia, United States, 30060
      • Aptinyx Clinical Site
  • Idaho
    • Blackfoot, Idaho, United States, 83221
      • Aptinyx Clinical Site
  • Illinois
    • Flossmoor, Illinois, United States, 60422
      • Aptinyx Clinical Site
  • Michigan
    • Rochester, Michigan, United States, 48307
      • Aptinyx Clinical Site
  • Missouri
    • Hazelwood, Missouri, United States, 63042
      • Aptinyx Clinical Site
  • Nevada
    • Las Vegas, Nevada, United States, 89123
      • Aptinyx Clinical Site
  • New York
    • Brooklyn, New York, United States, 11235
      • Aptinyx Clinical Site
    • New York, New York, United States, 10036
      • Aptinyx Clinical Site
    • Rochester, New York, United States, 14618
      • Aptinyx Clinical Site
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Aptinyx Clinical Site
    • Winston-Salem, North Carolina, United States, 27103
      • Aptinyx Clinical Site
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Aptinyx Clinical Site
  • Texas
    • Houston, Texas, United States, 77030
      • Aptinyx Clinical Site
    • Mesquite, Texas, United States, 75149
      • Aptinyx Clinical Site
    • Plano, Texas, United States, 75024
      • Aptinyx Clinical Site
    • San Antonio, Texas, United States, 78229
      • Aptinyx Clinical Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo administered orally
Experimental: NYX-2925; NYX-2925 50 mg	Drug: NYX-2925 50 mg; NYX-2925 administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Use of Rescue Medication	Number of subjects using rescue medication	Week 12

Collaborators and Investigators

• Sponsor: Aptinyx
• Collaborators: Worldwide Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2019
• Primary Completion (Actual): February 23, 2022
• Study Completion (Actual): February 23, 2022

Study Registration Dates

• First Submitted: October 29, 2019
• First Submitted That Met QC Criteria: October 30, 2019
• First Posted (Actual): October 31, 2019

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 7, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Neuralgia; Peripheral Nervous System Diseases
• Other Study ID Numbers: NYX-2925-2008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No