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| Name | Class |
|---|---|
| Worldwide Clinical Trials | OTHER |
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To evaluate the efficacy of NYX-2925 versus placebo in treating the neuropathic pain associated with diabetic peripheral neuropathy.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NYX-2925 | Experimental | NYX-2925 50 mg |
|
| Placebo | Placebo Comparator | Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NYX-2925 50 mg | Drug | NYX-2925 administered orally |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aptinyx Clinical Site | Fresno | California | 93720 | United States | ||
| Aptinyx Clinical Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | NYX-2925 | NYX-2925 50 mg QD NYX-2925 50 mg: NYX-2925 administered orally |
| FG001 | Placebo | Placebo QD Placebo: Placebo administered orally |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 25, 2021 | Mar 2, 2023 |
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Subjects will be randomized to receive either placebo or NYX-2925.
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Randomization algorithm, randomization allocation, allocation to study drug or placebo.
| Drug |
Placebo administered orally |
|
| Week 12 |
| Patient Global Impression of Change (PGI-C) | Number of subjects 'much improved' or 'very much improved' on Patient Global Impression of Change (PGI-C) | Week 12 |
| 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 | Week 12 |
| 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 | Week 12 |
| 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. | Week 12 |
| Use of Rescue Medication | Number of subjects using rescue medication | Week 12 |
| 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | NYX-2925 | NYX-2925 50 mg QD NYX-2925 50 mg: NYX-2925 administered orally |
| BG001 | Placebo | Placebo QD Placebo: Placebo administered orally |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Duration of DPN at Baseline (Years) | Mean | Standard Deviation | years |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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 | Posted | Mean | Standard Deviation | units on a scale | Week 12 |
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| Secondary | 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). | 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 | Posted | Mean | Standard Deviation | units on a scale | Week 12 |
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| Secondary | Patient Global Impression of Change (PGI-C) | Number of subjects 'much improved' or 'very much improved' on Patient Global Impression of Change (PGI-C) | 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 | Posted | Count of Participants | Participants | Week 12 |
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| Secondary | 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 | 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 | Posted | Count of Participants | Participants | Week 12 |
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| Secondary | 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 | 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 | Posted | Count of Participants | Participants | Week 12 |
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| Secondary | 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. | 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 | Posted | Mean | Standard Deviation | units on a scale | Week 12 |
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| Secondary | Use of Rescue Medication | Number of subjects using rescue medication | 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 | Posted | Count of Participants | Participants | Week 12 |
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Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NYX-2925 | NYX-2925 50 mg QD NYX-2925 50 mg: NYX-2925 administered orally | 0 | 114 | 1 | 114 | 15 | 114 |
| EG001 | Placebo | Placebo QD Placebo: Placebo administered orally | 2 | 114 | 6 | 114 | 15 | 114 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Coronary Syndrome | Cardiac disorders | Systematic Assessment |
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| Non Cardiac Acute Chest Pain | General disorders | Systematic Assessment |
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| Gastrointestinal Bleeding | Gastrointestinal disorders | Systematic Assessment |
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| Unstable Angina | Cardiac disorders | Systematic Assessment |
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| Chronic kidney disease exacerbation | Renal and urinary disorders | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | Systematic Assessment |
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| COVID-19 pneumonia | Infections and infestations | Systematic Assessment |
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| Worsening of coronary artery disease | Cardiac disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aptinyx Clinical Development | Aptinyx | 847-871-0377 | 1 | clinicalstudies@aptinyx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 17, 2022 | Mar 2, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000632586 | NYX-2925 |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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