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

Phase 2

Completed

• Conditions: Diabetic Peripheral Neuropathic Pain
• Interventions: Drug: NYX-2925 50 mg; Drug: Placebo

• Registration Number: NCT04146896
• Lead Sponsor: Aptinyx

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-10-29
• Study First Submitted QC: 2019-10-30
• Study First Posted: 2019-10-31
• Study Start: 2019-11-12
• Primary Completion: 2022-02-23
• Study Completion: 2022-02-23
• Results First Submitted: 2023-03-02
• Status Verified: 2023-04
• Results First Submitted QC: 2023-04-07
• Last Update Submitted: 2023-04-07
• Results First Posted: 2023-04-28
• Last Update Posted: 2023-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 228

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NYX-2925	NYX-2925 50 mg	NYX-2925 50 mg
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Pain Intensity Numeric Rating Scale (NRS) Score	Week 12	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.

Secondary Outcome Measures

Name	Time	Method
Daily Sleep Interference Scale (DSIS) Score	Week 12	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).
Patient Global Impression of Change (PGI-C)	Week 12	Number of subjects 'much improved' or 'very much improved' on Patient Global Impression of Change (PGI-C)
Norfolk Quality of Life Questionnaire - Diabetic Neuropathy (QOL-DN) Score	Week 12	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.
Use of Rescue Medication	Week 12	Number of subjects using rescue medication
Number of Subjects Achieving ≥30% Pain Reduction	Week 12	Number of subjects achieving ≥30% pain reduction from baseline in the weekly mean NRS average pain intensity related to DPN
Number of Subjects Achieving ≥50% Reduction	Week 12	Number of subjects achieving ≥50% reduction from baseline in the weekly mean NRS average pain intensity related to DPN

Trial Locations

Locations (1)

Aptinyx Clinical Site; 🇺🇸 San Antonio, Texas, United States