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Trial record 2 of 5 for:    NYX-2925

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04146896
Recruitment Status : Recruiting
First Posted : October 31, 2019
Last Update Posted : January 12, 2021
Sponsor:
Collaborator:
Worldwide Clinical Trials
Information provided by (Responsible Party):
Aptinyx

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

Condition or disease Intervention/treatment Phase
Diabetic Peripheral Neuropathic Pain Drug: NYX-2925 50 mg Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized to receive either placebo or NYX-2925.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Randomization algorithm, randomization allocation, allocation to study drug or placebo.
Primary Purpose: Treatment
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
Actual Study Start Date : November 12, 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NYX-2925
NYX-2925 50 mg
Drug: NYX-2925 50 mg
NYX-2925 administered orally

Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo administered orally




Primary Outcome Measures :
  1. 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 Outcome Measures :
  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 ]
    Percentage of subjects 'much improved' or 'very much improved' on Patient Global Impression of Change (PGI-C)

  3. Percentage of subjects achieving ≥30% pain reduction [ Time Frame: Week 12 ]
    Percentage of subjects achieving ≥30% pain reduction from baseline in the weekly mean NRS average pain intensity related to DPN

  4. Percentage of subjects achieving ≥50% reduction [ Time Frame: Week 12 ]
    Percentage 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, in which lower scores indicate improved quality of life.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04146896


Contacts
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Contact: Aptinyx Clinical Development 847 871 0377 ext 1 clinicalstudies@aptinyx.com

Locations
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United States, Arizona
Aptinyx Clinical Site Active, not recruiting
Chandler, Arizona, United States, 85224
Aptinyx Clinical Site Active, not recruiting
Glendale, Arizona, United States, 85306
Aptinyx Clinical Site Active, not recruiting
Mesa, Arizona, United States, 85206
Aptinyx Clinical Site Active, not recruiting
Phoenix, Arizona, United States, 85050
Aptinyx Clinical Site Active, not recruiting
Tucson, Arizona, United States, 85741
United States, California
Aptinyx Clinical Site Active, not recruiting
Carlsbad, California, United States, 92008
Aptinyx Clinical Site Recruiting
Fresno, California, United States, 93720
Aptinyx Clinical Site Recruiting
Lomita, California, United States, 90717
Aptinyx Clinical Site Active, not recruiting
Santa Rosa, California, United States, 95405
United States, Florida
Aptinyx Clinical Site Recruiting
Brandon, Florida, United States, 33511
Aptinyx Clinical Site Recruiting
Clearwater, Florida, United States, 33765
Aptinyx Clinical Site Active, not recruiting
Pinellas Park, Florida, United States, 33781
Aptinyx Clinical Site Recruiting
Tampa, Florida, United States, 33606
United States, Idaho
Aptinyx Clinical Site Recruiting
Blackfoot, Idaho, United States, 83221
United States, Illinois
Aptinyx Clinical Site Recruiting
Flossmoor, Illinois, United States, 60422
United States, Indiana
Aptinyx Clinical Site Active, not recruiting
Evansville, Indiana, United States, 47714
United States, Minnesota
Aptinyx Clinical Site Active, not recruiting
Richfield, Minnesota, United States, 55423
United States, Missouri
Aptinyx Clinical Site Recruiting
Hazelwood, Missouri, United States, 63042
Aptinyx Clinical Site Active, not recruiting
Saint Louis, Missouri, United States, 63141
United States, Nevada
Aptinyx Clinical Site Recruiting
Las Vegas, Nevada, United States, 89123
United States, New York
Aptinyx Clinical Site Recruiting
New York, New York, United States, 10036
United States, Ohio
Aptinyx Clinical Site Active, not recruiting
Cincinnati, Ohio, United States, 45236
Aptinyx Clinical Site Active, not recruiting
Columbus, Ohio, United States, 43212
United States, Oklahoma
Aptinyx Clinical Site Recruiting
Oklahoma City, Oklahoma, United States, 73111
United States, South Carolina
Aptinyx Clinical Site Active, not recruiting
Greer, South Carolina, United States, 29651
United States, Texas
Aptinyx Clinical Site Active, not recruiting
Dallas, Texas, United States, 75234
Aptinyx Clinical Site Active, not recruiting
Plano, Texas, United States, 75093
Aptinyx Clinical Site Recruiting
San Antonio, Texas, United States, 78229
United States, Utah
Aptinyx Clinical Site Active, not recruiting
Murray, Utah, United States, 84123
Sponsors and Collaborators
Aptinyx
Worldwide Clinical Trials
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Responsible Party: Aptinyx
ClinicalTrials.gov Identifier: NCT04146896    
Other Study ID Numbers: NYX-2925-2008
First Posted: October 31, 2019    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations