Trial · NCT04146896
Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy (DPN)
NCT04146896, Phase 2, Completed, Aptinyx; results first posted 2023-04-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy (DPN). Trials, record NCT04146896. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04146896
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy (DPN)
- NCT number
- NCT04146896
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 228 participants, actual
- Lead sponsor
- Aptinyx
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Interventions
- NYX-2925 50 mg, Placebo
- First posted
- 2019-10-31
- Last updated
- 2023-04-28
- Results first posted
- 2023-04-28
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain Intensity Numeric Rating Scale (NRS) Score | 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 | Daily Sleep Interference Scale (DSIS) Score | 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). |
| Secondary | Patient Global Impression of Change (PGI-C) | Week 12 | Number of subjects 'much improved' or 'very much improved' on Patient Global Impression of Change (PGI-C) |
| Secondary | Number of Subjects Achieving ≥30% Pain Reduction | Week 12 | Number of subjects achieving ≥30% pain reduction from baseline in the weekly mean NRS average pain intensity related to DPN |
| Secondary | Number of Subjects Achieving ≥50% Reduction | Week 12 | Number of subjects achieving ≥50% reduction from baseline in the weekly mean NRS average pain intensity related to DPN |
| Secondary | Norfolk Quality of Life Questionnaire - Diabetic Neuropathy (QOL-DN) Score | 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. Scores range from 0-126, and lower scores indicate improved quality of life. |
| Secondary | Use of Rescue Medication | Week 12 | Number of subjects using rescue medication |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pain Intensity Numeric Rating Scale (NRS) Score | Week 12 | Modified Intent to Treat Population includes all subjects who received at least one dose of study drug with at least one post-baseline assessment of the pain intensity NRS | units on a scale | MEAN |
| SECONDARY | Daily Sleep Interference Scale (DSIS) Score | Week 12 | Population Description: Modified Intent to Treat Population includes all subjects who received at least one dose of study drug with at least one post-baseline assessment of the pain intensity NRS | units on a scale | MEAN |
| SECONDARY | Patient Global Impression of Change (PGI-C) | Week 12 | Population Description: Modified Intent to Treat Population includes all subjects who received at least one dose of study drug with at least one post-baseline assessment of the pain intensity NRS | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Achieving ≥30% Pain Reduction | Week 12 | Population Description: Modified Intent to Treat Population includes all subjects who received at least one dose of study drug with at least one post-baseline assessment of the pain intensity NRS | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Achieving ≥50% Reduction | Week 12 | Population Description: Modified Intent to Treat Population includes all subjects who received at least one dose of study drug with at least one post-baseline assessment of the pain intensity NRS | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Norfolk Quality of Life Questionnaire - Diabetic Neuropathy (QOL-DN) Score | Week 12 | Population Description: Modified Intent to Treat Population includes all subjects who received at least one dose of study drug with at least one post-baseline assessment of the pain intensity NRS | units on a scale | MEAN |
| SECONDARY | Use of Rescue Medication | Week 12 | Population Description: Modified Intent to Treat Population includes all subjects who received at least one dose of study drug with at least one post-baseline assessment of the pain intensity NRS | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pain Intensity Numeric Rating Scale (NRS) Score | NYX-2925 | -2.01 | Standard Deviation 1.821 | units on a scale | |
| Pain Intensity Numeric Rating Scale (NRS) Score | Placebo | -2.27 | Standard Deviation 2.102 | units on a scale | |
| Daily Sleep Interference Scale (DSIS) Score | NYX-2925 | -2.11 | Standard Deviation 1.903 | units on a scale | |
| Daily Sleep Interference Scale (DSIS) Score | Placebo | -2.39 | Standard Deviation 2.344 | units on a scale | |
| Patient Global Impression of Change (PGI-C) | NYX-2925 | 38 | Participants | ||
| Patient Global Impression of Change (PGI-C) | Placebo | 40 | Participants | ||
| Number of Subjects Achieving ≥30% Pain Reduction | NYX-2925 | 51 | Participants | ||
| Number of Subjects Achieving ≥30% Pain Reduction | Placebo | 52 | Participants | ||
| Number of Subjects Achieving ≥50% Reduction | NYX-2925 | 29 | Participants | ||
| Number of Subjects Achieving ≥50% Reduction | Placebo | 35 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NYX-2925 | 114 | |
| Overall Study | STARTED | Placebo | 114 | |
| Overall Study | COMPLETED | NYX-2925 | 97 | |
| Overall Study | COMPLETED | Placebo | 92 | |
| Overall Study | NOT COMPLETED | NYX-2925 | 17 | |
| Overall Study | NOT COMPLETED | Placebo | 22 |
Source ClinicalTrials.gov
Adverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | NYX-2925 | 5 | 114 | 5 |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 7 | 114 | 7 |
| other | Nausea | Gastrointestinal disorders | NYX-2925 | 3 | 114 | 3 |
| other | Nausea | Gastrointestinal disorders | Placebo | 2 | 114 | 2 |
| other | Vomiting | Gastrointestinal disorders | NYX-2925 | 2 | 114 | 2 |
| other | Vomiting | Gastrointestinal disorders | Placebo | 2 | 114 | 2 |
| other | Headache | Nervous system disorders | NYX-2925 | 5 | 114 | 5 |
| other | Headache | Nervous system disorders | Placebo | 4 | 114 | 5 |
| serious | Acute Coronary Syndrome | Cardiac disorders | NYX-2925 | 1 | 114 | 1 |
| serious | Acute Coronary Syndrome | Cardiac disorders | Placebo | 0 | 114 | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NYX-2925 | 0 | 114 |
| Total, all-cause mortality | Placebo | 2 | 114 |
| Total, other adverse events | NYX-2925 | 15 | 114 |
| Total, other adverse events | Placebo | 15 | 114 |
| Total, serious adverse events | NYX-2925 | 1 | 114 |
| Total, serious adverse events | Placebo | 6 | 114 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| NYX-2925 vs Placebo: Patient Global Impression of Change (PGI-C) | Trial comparisons |
| NYX-2925 vs Placebo: Use of Rescue Medication | Trial comparisons |
| NYX-2925 vs Placebo: Number of Subjects Achieving ≥50% Reduction | Trial comparisons |
| NYX-2925 vs Placebo: Number of Subjects Achieving ≥30% Pain Reduction | Trial comparisons |
| NYX-2925 vs Placebo: deaths from any cause | Trial comparisons |
| NYX-2925 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04146896
GET https://conductscience.org/api/trials/v1/NCT04146896/events?page=2