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Completed

NCT Number: NCT04146896

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

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

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Key information

Conditions

Diabetic Peripheral Neuropathic Pain

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aptinyx Clinical Site, Fresno, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NYX-2925 50 mg

Drug

NYX-2925 administered orally

Placebo

Drug

Placebo administered orally

Primary outcomes

  1. Pain Intensity Numeric Rating Scale (NRS) Score

    Time frame: 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 outcomes

  1. Daily Sleep Interference Scale (DSIS) Score

    Time frame: 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).

  2. Patient Global Impression of Change (PGI-C)

    Time frame: Week 12

    Number of subjects 'much improved' or 'very much improved' on Patient Global Impression of Change (PGI-C)

  3. Number of Subjects Achieving ≥30% Pain Reduction

    Time frame: Week 12

    Number of subjects achieving ≥30% pain reduction from baseline in the weekly mean NRS average pain intensity related to DPN

  4. Number of Subjects Achieving ≥50% Reduction

    Time frame: Week 12

    Number of subjects achieving ≥50% reduction from baseline in the weekly mean NRS average pain intensity related to DPN

  5. Norfolk Quality of Life Questionnaire - Diabetic Neuropathy (QOL-DN) Score

    Time frame: 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.

  6. Use of Rescue Medication

    Time frame: Week 12

    Number of subjects using rescue medication

Sponsors and collaborators

Lead sponsor

Aptinyx

Industry

Collaborators

  • Worldwide Clinical Trials

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 31, 2019
Registry last updated
Apr 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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