Phase 2
N=228
Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy (DPN)
Diabetic Peripheral Neuropathic Pain
Bottom Line
View on ClinicalTrials.gov: NCT04146896 ↗Enrolled (actual)
228
Serious AEs
3.1%
Results posted
Apr 2023
Primary outcome: Primary: Pain Intensity Numeric Rating Scale (NRS) Score — -2.01; -2.27 units on a scale — p=0.704
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- NYX-2925 50 mg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Aptinyx
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Intensity Numeric Rating Scale (NRS) Score |
-2.01; -2.27 | 0.704 |
| SECONDARY Daily Sleep Interference Scale (DSIS) Score |
-2.11; -2.39 | .684 |
| SECONDARY Patient Global Impression of Change (PGI-C) |
38; 40 | 0.743 |
| SECONDARY Number of Subjects Achieving ≥30% Pain Reduction |
51; 52 | .483 |
| SECONDARY Number of Subjects Achieving ≥50% Reduction |
29; 35 | .199 |
| SECONDARY Norfolk Quality of Life Questionnaire - Diabetic Neuropathy (QOL-DN) Score |
-15.3; -16.7 | .273 |
| SECONDARY Use of Rescue Medication |
100; 97 | .668 |
Summary
To evaluate the efficacy of NYX-2925 versus placebo in treating the neuropathic pain associated with diabetic peripheral neuropathy.
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
Data sourced from ClinicalTrials.gov (NCT04146896). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.