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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Diabetic Peripheral Neuropathic Pain

Intervention / Treatment
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* Drug: NYX-2925 50 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomized to receive either placebo or NYX-2925.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NYX-2925<br>NYX-2925 50 mg | Drug: NYX-2925 50 mg<br>* NYX-2925 administered orally<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo administered orally<br>|

What is the study measuring?
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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 |