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

Primary Purpose

Diabetic Peripheral Neuropathic Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NYX-2925 50 mg
Placebo
Sponsored by
Aptinyx
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Peripheral Neuropathic Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site
  • Aptinyx Clinical Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NYX-2925

Placebo

Arm Description

NYX-2925 50 mg

Placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
Patient Global Impression of Change (PGI-C)
Number of subjects 'much improved' or 'very much improved' on Patient Global Impression of Change (PGI-C)
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
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
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.
Use of Rescue Medication
Number of subjects using rescue medication

Full Information

First Posted
October 29, 2019
Last Updated
April 7, 2023
Sponsor
Aptinyx
Collaborators
Worldwide Clinical Trials
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1. Study Identification

Unique Protocol Identification Number
NCT04146896
Brief Title
Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy (DPN)
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 12, 2019 (Actual)
Primary Completion Date
February 23, 2022 (Actual)
Study Completion Date
February 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aptinyx
Collaborators
Worldwide Clinical Trials

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized to receive either placebo or NYX-2925.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Randomization algorithm, randomization allocation, allocation to study drug or placebo.
Allocation
Randomized
Enrollment
228 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NYX-2925
Arm Type
Experimental
Arm Description
NYX-2925 50 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
NYX-2925 50 mg
Intervention Description
NYX-2925 administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered orally
Primary Outcome Measure Information:
Title
Pain Intensity Numeric Rating Scale (NRS) Score
Description
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.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Daily Sleep Interference Scale (DSIS) Score
Description
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).
Time Frame
Week 12
Title
Patient Global Impression of Change (PGI-C)
Description
Number of subjects 'much improved' or 'very much improved' on Patient Global Impression of Change (PGI-C)
Time Frame
Week 12
Title
Number of Subjects Achieving ≥30% Pain Reduction
Description
Number of subjects achieving ≥30% pain reduction from baseline in the weekly mean NRS average pain intensity related to DPN
Time Frame
Week 12
Title
Number of Subjects Achieving ≥50% Reduction
Description
Number of subjects achieving ≥50% reduction from baseline in the weekly mean NRS average pain intensity related to DPN
Time Frame
Week 12
Title
Norfolk Quality of Life Questionnaire - Diabetic Neuropathy (QOL-DN) Score
Description
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.
Time Frame
Week 12
Title
Use of Rescue Medication
Description
Number of subjects using rescue medication
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Aptinyx Clinical Site
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Aptinyx Clinical Site
City
Irvine
State/Province
California
ZIP/Postal Code
92612
Country
United States
Facility Name
Aptinyx Clinical Site
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
Aptinyx Clinical Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Aptinyx Clinical Site
City
Norco
State/Province
California
ZIP/Postal Code
92860
Country
United States
Facility Name
Aptinyx Clinical Site
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
Aptinyx Clinical Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Aptinyx Clinical Site
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Aptinyx Clinical Site
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Aptinyx Clinical Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Aptinyx Clinical Site
City
Greenacres City
State/Province
Florida
ZIP/Postal Code
33467
Country
United States
Facility Name
Aptinyx Clinical Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Aptinyx Clinical Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Aptinyx Clinical Site
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Aptinyx Clinical Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Facility Name
Aptinyx Clinical Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Facility Name
Aptinyx Clinical Site
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Aptinyx Clinical Site
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Aptinyx Clinical Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Aptinyx Clinical Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Aptinyx Clinical Site
City
Blackfoot
State/Province
Idaho
ZIP/Postal Code
83221
Country
United States
Facility Name
Aptinyx Clinical Site
City
Flossmoor
State/Province
Illinois
ZIP/Postal Code
60422
Country
United States
Facility Name
Aptinyx Clinical Site
City
Rochester
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Facility Name
Aptinyx Clinical Site
City
Hazelwood
State/Province
Missouri
ZIP/Postal Code
63042
Country
United States
Facility Name
Aptinyx Clinical Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Aptinyx Clinical Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Aptinyx Clinical Site
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
Aptinyx Clinical Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Aptinyx Clinical Site
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Aptinyx Clinical Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Aptinyx Clinical Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Aptinyx Clinical Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Aptinyx Clinical Site
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Facility Name
Aptinyx Clinical Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
Aptinyx Clinical Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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