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| Name | Class |
|---|---|
| Worldwide Clinical Trials | OTHER |
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To evaluate the efficacy of NYX-2925 versus placebo for the treatment of fibromyalgia.
This is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of NYX-2925 in subjects with fibromyalgia.
This 13- to 16-week study will include 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 50 mg | Experimental | NYX-2925 50 mg administered orally. |
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| NYX-2925 100 mg | Experimental | NYX-2925 100 mg administered orally. |
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| Placebo | Placebo Comparator | Placebo administered orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NYX-2925 | Drug | NYX-2925 administered orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Mean Numerical Rating Scale (NRS) Score | Change from baseline to Week 12 in the weekly mean of the daily Numerical Rating Scale (NRS) score assessing average pain intensity in the past 24 hours, scores range from 0-10, with higher scores indicating worse pain (0 being no pain and 10 being the worst possible pain) | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGI-C) at Week 12 | Number of subjects "much improved" or "very much improved" on the Patient Global Impression of Change (PGI-C) at Week 12 | Week 12 |
| Daily Sleep Interference (DSIS) Score |
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Inclusion criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aptinyx Clinical Site | Phoenix | Arizona | 85012 | United States | ||
| Aptinyx Clinical Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | NYX-2925 50 mg | NYX-2925 50 mg administered orally. |
| FG001 | NYX-2925 100 mg | NYX-2925 100 mg 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 | Oct 14, 2021 | Mar 2, 2023 |
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Randomization algorithm, randomization allocation, allocation to study drug or placebo.
| Placebo |
| Drug |
Placebo administered orally |
|
Change from baseline in the weekly mean of the Daily Sleep Interference Scale (DSIS) scores at Week 12; Response options range from 0 (Did not interfere with sleep) to 10 (Completely interfered with sleep, unable to sleep due to pain), with higher scores indicating greater interference with sleep. |
| Week 12 |
| Number of Subjects Achieving ≥30% Pain Reduction | Number of subjects achieving ≥30% reduction from baseline in the weekly mean NRS average pain intensity at Week 12; NRS Scores range from 0-10, with higher scores indicating worse pain (0 being no pain and 10 being the worst possible pain). | Week 12 |
| Number of Subjects Achieving ≥50% Pain Reduction | Number of subjects achieving ≥50% reduction from baseline in the weekly mean NRS average pain intensity at Week 12; NRS scores range from 0-10, with higher scores indicating worse pain (0 being no pain and 10 being the worst possible pain) | Week 12 |
| Fibromyalgia Impact Questionnaire-Revised (FIQR) Score | Change from baseline to Week 12 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) score; FIQR scores range from 0-100, with higher scores indicating greater impact of fibromyalgia | Week 12 |
| Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Sleep Disturbance Score | Change from baseline to Week 12 in the PROMIS-FM sleep disturbance score, scores range from 0-40, with higher scores indicating greater sleep disturbance. | Week 12 |
| Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Fatigue Profile Score | Change from baseline to Week 12 in the PROMIS-FM fatigue profile score, scores range from 0-80, with higher scores indicating greater impact of fatigue | Week 12 |
| Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Physical Function Score | Change from baseline to Week 12 in the PROMIS-FM physical function score, scores range from 0-60, with higher scores indicating greater difficulty with physical function. | Week 12 |
| Use of Rescue Medication | The number of subjects using rescue medication. | Week 12 |
| Culver City |
| California |
| 90230 |
| United States |
| Aptinyx Clinical Site | Fresno | California | 93710 | United States |
| Aptinyx Clinical Site | Orange | California | 92868 | United States |
| Aptinyx Clinical Site | Redlands | California | 92374 | United States |
| Aptinyx Clinical Site | Temecula | California | 92591 | United States |
| Aptinyx Clinical Site | Torrance | California | 90502 | United States |
| Aptinyx Clinical Site | Fernandina Beach | Florida | 32034 | United States |
| Aptinyx Clinical Site | Jacksonville | Florida | 32224 | United States |
| Aptinyx Clinical Site | Jacksonville | Florida | 32256 | United States |
| Aptinyx Clinical Site | Lady Lake | Florida | 32159 | United States |
| Aptinyx Clinical Site | Miami | Florida | 33165 | United States |
| Aptinyx Clinical Site | Orlando | Florida | 32801 | United States |
| Aptinyx Clinical Site | Palmetto Bay | Florida | 33157 | United States |
| Aptinyx Clinical Site | Winter Park | Florida | 32789 | United States |
| Aptinyx Clinical Site | Alpharetta | Georgia | 30022 | United States |
| Aptinyx Clinical Site | Chicago | Illinois | 60607 | United States |
| Aptinyx Clinical Site | Flossmoor | Illinois | 60422 | United States |
| Aptinyx Clinical Site | Gurnee | Illinois | 60031 | United States |
| Aptinyx Clinical Site | Skokie | Illinois | 60076 | United States |
| Aptinyx Clinical Site | Evansville | Indiana | 47714 | United States |
| Aptinyx Clinical Site | West Des Moines | Iowa | 50265 | United States |
| Aptinyx Clinical Site | Newton | Kansas | 67114 | United States |
| Aptinyx Clinical Site | Prairie Village | Kansas | 66208 | United States |
| Aptinyx Clinical Site | Wichita | Kansas | 67205 | United States |
| Aptinyx Clinical Site | Roslindale | Massachusetts | 02131 | United States |
| Aptinyx Clinical Site | Hazelwood | Missouri | 63042 | United States |
| Aptinyx Clinical Site | Omaha | Nebraska | 68114 | United States |
| Aptinyx Clinical Site | Las Vegas | Nevada | 89102 | United States |
| Aptinyx Clinical Site | Brooklyn | New York | 11235 | United States |
| Aptinyx Clinical Site | New York | New York | 10017 | United States |
| Aptinyx Clinical Site | New York | New York | 10036 | United States |
| Aptinyx Clinical Site | Staten Island | New York | 10312 | United States |
| Aptinyx Clinical Site | Williamsville | New York | 14221 | United States |
| Aptinyx Clinical Site | Cincinnati | Ohio | 45219 | United States |
| Aptinyx Clinical Site | Oklahoma City | Oklahoma | 73106 | United States |
| Aptinyx Clinical Site | Duncansville | Pennsylvania | 16635 | United States |
| Aptinyx Clinical Site | Memphis | Tennessee | 38119 | United States |
| Aptinyx Clinical Site | Austin | Texas | 78737 | United States |
| Aptinyx Clinical Site | Houston | Texas | 77077 | United States |
| Aptinyx Clinical Site | Danville | Virginia | 24541 | United States |
| Aptinyx Clinical Site | Bellevue | Washington | 98007 | United States |
| FG002 |
| Placebo |
Placebo administered orally. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | NYX-2925 50 mg | NYX-2925 50 mg administered orally once daily. |
| BG001 | NYX-2925 100 mg | NYX-2925 100 mg administered orally once daily. |
| BG002 | Placebo | Placebo administered orally once daily. |
| BG003 | 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 |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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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 | Change in the Mean Numerical Rating Scale (NRS) Score | Change from baseline to Week 12 in the weekly mean of the daily Numerical Rating Scale (NRS) score assessing average pain intensity in the past 24 hours, scores range from 0-10, with higher scores indicating worse pain (0 being no pain and 10 being the worst possible pain) | Posted | Mean | Standard Deviation | units on a scale | Week 12 |
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| Secondary | Number of Subjects "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGI-C) at Week 12 | Number of subjects "much improved" or "very much improved" on the Patient Global Impression of Change (PGI-C) at Week 12 | Posted | Count of Participants | Participants | Week 12 |
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| Secondary | Daily Sleep Interference (DSIS) Score | Change from baseline in the weekly mean of the Daily Sleep Interference Scale (DSIS) scores at Week 12; Response options range from 0 (Did not interfere with sleep) to 10 (Completely interfered with sleep, unable to sleep due to pain), with higher scores indicating greater interference with sleep. | Posted | Mean | Standard Deviation | units on a scale | Week 12 |
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| Secondary | Number of Subjects Achieving ≥30% Pain Reduction | Number of subjects achieving ≥30% reduction from baseline in the weekly mean NRS average pain intensity at Week 12; NRS Scores range from 0-10, with higher scores indicating worse pain (0 being no pain and 10 being the worst possible pain). | Posted | Count of Participants | Participants | Week 12 |
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| Secondary | Number of Subjects Achieving ≥50% Pain Reduction | Number of subjects achieving ≥50% reduction from baseline in the weekly mean NRS average pain intensity at Week 12; NRS scores range from 0-10, with higher scores indicating worse pain (0 being no pain and 10 being the worst possible pain) | Posted | Count of Participants | Participants | Week 12 |
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| Secondary | Fibromyalgia Impact Questionnaire-Revised (FIQR) Score | Change from baseline to Week 12 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) score; FIQR scores range from 0-100, with higher scores indicating greater impact of fibromyalgia | Posted | Mean | Standard Deviation | units on a scale | Week 12 |
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| Secondary | Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Sleep Disturbance Score | Change from baseline to Week 12 in the PROMIS-FM sleep disturbance score, scores range from 0-40, with higher scores indicating greater sleep disturbance. | Posted | Mean | Standard Deviation | units on a scale | Week 12 |
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| Secondary | Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Fatigue Profile Score | Change from baseline to Week 12 in the PROMIS-FM fatigue profile score, scores range from 0-80, with higher scores indicating greater impact of fatigue | Posted | Mean | Standard Deviation | units on a scale | Week 12 |
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| Secondary | Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Physical Function Score | Change from baseline to Week 12 in the PROMIS-FM physical function score, scores range from 0-60, with higher scores indicating greater difficulty with physical function. | Posted | Mean | Standard Deviation | units on a scale | Week 12 |
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| Secondary | Use of Rescue Medication | The number of subjects using rescue medication. | 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.
MedDRA (24.1)
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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 50 mg | NYX-2925 50 mg administered orally once daily. | 0 | 101 | 0 | 101 | 18 | 101 |
| EG001 | NYX-2925 100 mg | NYX-2925 100 mg administered orally once daily. | 0 | 104 | 2 | 104 | 19 | 104 |
| EG002 | Placebo | Placebo administered orally once daily. | 0 | 105 | 0 | 105 | 18 | 105 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| COVID-19 | Infections and infestations | 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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| Fatigue | General disorders | Systematic Assessment |
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| COVID-19 | Infections and infestations | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | 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 | Jul 21, 2022 | Mar 2, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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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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