Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy (DPN)
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
1 other identifier
interventional
228
1 country
35
Brief Summary
To evaluate the efficacy of NYX-2925 versus placebo in treating the neuropathic pain associated with diabetic peripheral neuropathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2019
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2019
CompletedFirst Posted
Study publicly available on registry
October 31, 2019
CompletedStudy Start
First participant enrolled
November 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 23, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2022
CompletedResults Posted
Study results publicly available
April 28, 2023
CompletedApril 28, 2023
April 1, 2023
2.3 years
October 29, 2019
March 2, 2023
April 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Daily Sleep Interference Scale (DSIS) Score
Week 12
Patient Global Impression of Change (PGI-C)
Week 12
Number of Subjects Achieving ≥30% Pain Reduction
Week 12
Number of Subjects Achieving ≥50% Reduction
Week 12
Norfolk Quality of Life Questionnaire - Diabetic Neuropathy (QOL-DN) Score
Week 12
- +1 more secondary outcomes
Study Arms (2)
NYX-2925
EXPERIMENTALNYX-2925 50 mg
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aptinyxlead
- Worldwide Clinical Trialscollaborator
Study Sites (35)
Aptinyx Clinical Site
Fresno, California, 93720, United States
Aptinyx Clinical Site
Irvine, California, 92612, United States
Aptinyx Clinical Site
Lomita, California, 90717, United States
Aptinyx Clinical Site
Los Angeles, California, 90048, United States
Aptinyx Clinical Site
Norco, California, 92860, United States
Aptinyx Clinical Site
Pomona, California, 91767, United States
Aptinyx Clinical Site
Santa Ana, California, 92705, United States
Aptinyx Clinical Site
Tustin, California, 92780, United States
Aptinyx Clinical Site
Brandon, Florida, 33511, United States
Aptinyx Clinical Site
Clearwater, Florida, 33765, United States
Aptinyx Clinical Site
Greenacres City, Florida, 33467, United States
Aptinyx Clinical Site
Miami, Florida, 33126, United States
Aptinyx Clinical Site
Miami, Florida, 33144, United States
Aptinyx Clinical Site
New Port Richey, Florida, 34655, United States
Aptinyx Clinical Site
Tampa, Florida, 33615, United States
Aptinyx Clinical Site
Tampa, Florida, 33634, United States
Aptinyx Clinical Site
Winter Haven, Florida, 33880, United States
Aptinyx Clinical Site
Winter Park, Florida, 32789, United States
Aptinyx Clinical Site
Decatur, Georgia, 30030, United States
Aptinyx Clinical Site
Marietta, Georgia, 30060, United States
Aptinyx Clinical Site
Blackfoot, Idaho, 83221, United States
Aptinyx Clinical Site
Flossmoor, Illinois, 60422, United States
Aptinyx Clinical Site
Rochester, Michigan, 48307, United States
Aptinyx Clinical Site
Hazelwood, Missouri, 63042, United States
Aptinyx Clinical Site
Las Vegas, Nevada, 89123, United States
Aptinyx Clinical Site
Brooklyn, New York, 11235, United States
Aptinyx Clinical Site
New York, New York, 10036, United States
Aptinyx Clinical Site
Rochester, New York, 14618, United States
Aptinyx Clinical Site
Greenville, North Carolina, 27834, United States
Aptinyx Clinical Site
Winston-Salem, North Carolina, 27103, United States
Aptinyx Clinical Site
Duncansville, Pennsylvania, 16635, United States
Aptinyx Clinical Site
Houston, Texas, 77030, United States
Aptinyx Clinical Site
Mesquite, Texas, 75149, United States
Aptinyx Clinical Site
Plano, Texas, 75024, United States
Aptinyx Clinical Site
San Antonio, Texas, 78229, United States
MeSH Terms
Interventions
Results Point of Contact
- Title
- Aptinyx Clinical Development
- Organization
- Aptinyx
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Randomization algorithm, randomization allocation, allocation to study drug or placebo.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2019
First Posted
October 31, 2019
Study Start
November 12, 2019
Primary Completion
February 23, 2022
Study Completion
February 23, 2022
Last Updated
April 28, 2023
Results First Posted
April 28, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share