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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04146896
Recruitment Status : Active, not recruiting
First Posted : October 31, 2019
Last Update Posted : October 28, 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)
Actual Enrollment : 229 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.

  6. Use of rescue medication [ Time Frame: Week 12 ]
    Use of rescue medication, including the proportion of subjects using rescue medication, the frequency and amount used

  7. Cumulative response (percent reduction from baseline) [ Time Frame: Week 12 ]
    Cumulative response (percent reduction from baseline) in the weekly mean NRS average pain intensity at Week 12

  8. Change from baseline in mean NRS at each week [ Time Frame: Week 1 - Week 12 ]
    Change from baseline in the weekly mean of the daily Numerical Rating Scale (NRS) at each week from Week 1 through Week 12



Information from the National Library of Medicine

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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


Locations
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United States, California
Aptinyx Clinical Site
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
United States, Florida
Aptinyx Clinical Site
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
United States, Georgia
Aptinyx Clinical Site
Decatur, Georgia, United States, 30030
Aptinyx Clinical Site
Marietta, Georgia, United States, 30060
United States, Idaho
Aptinyx Clinical Site
Blackfoot, Idaho, United States, 83221
United States, Illinois
Aptinyx Clinical Site
Flossmoor, Illinois, United States, 60422
United States, Michigan
Aptinyx Clinical Site
Rochester, Michigan, United States, 48307
United States, Missouri
Aptinyx Clinical Site
Hazelwood, Missouri, United States, 63042
United States, Nevada
Aptinyx Clinical Site
Las Vegas, Nevada, United States, 89123
United States, New York
Aptinyx Clinical Site
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
United States, North Carolina
Aptinyx Clinical Site
Greenville, North Carolina, United States, 27834
Aptinyx Clinical Site
Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
Aptinyx Clinical Site
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Aptinyx Clinical Site
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
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: October 28, 2021
Last Verified: October 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