Fibromyalgia Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia
Verified date | April 2023 |
Source | Aptinyx |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the efficacy of NYX-2925 versus placebo for the treatment of fibromyalgia.
Status | Completed |
Enrollment | 310 |
Est. completion date | June 16, 2022 |
Est. primary completion date | June 16, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion criteria: - Informed consent - Subject has a history of fibromyalgia that was diagnosed >1 year prior to screening and reports at least moderate pain over the last week - Stable protocol allowed medication and other therapies 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 |
Country | Name | City | State |
---|---|---|---|
United States | Aptinyx Clinical Site | Alpharetta | Georgia |
United States | Aptinyx Clinical Site | Austin | Texas |
United States | Aptinyx Clinical Site | Bellevue | Washington |
United States | Aptinyx Clinical Site | Brooklyn | New York |
United States | Aptinyx Clinical Site | Chicago | Illinois |
United States | Aptinyx Clinical Site | Cincinnati | Ohio |
United States | Aptinyx Clinical Site | Culver City | California |
United States | Aptinyx Clinical Site | Danville | Virginia |
United States | Aptinyx Clinical Site | Duncansville | Pennsylvania |
United States | Aptinyx Clinical Site | Evansville | Indiana |
United States | Aptinyx Clinical Site | Fernandina Beach | Florida |
United States | Aptinyx Clinical Site | Flossmoor | Illinois |
United States | Aptinyx Clinical Site | Fresno | California |
United States | Aptinyx Clinical Site | Gurnee | Illinois |
United States | Aptinyx Clinical Site | Hazelwood | Missouri |
United States | Aptinyx Clinical Site | Houston | Texas |
United States | Aptinyx Clinical Site | Jacksonville | Florida |
United States | Aptinyx Clinical Site | Jacksonville | Florida |
United States | Aptinyx Clinical Site | Lady Lake | Florida |
United States | Aptinyx Clinical Site | Las Vegas | Nevada |
United States | Aptinyx Clinical Site | Memphis | Tennessee |
United States | Aptinyx Clinical Site | Miami | Florida |
United States | Aptinyx Clinical Site | New York | New York |
United States | Aptinyx Clinical Site | New York | New York |
United States | Aptinyx Clinical Site | Newton | Kansas |
United States | Aptinyx Clinical Site | Oklahoma City | Oklahoma |
United States | Aptinyx Clinical Site | Omaha | Nebraska |
United States | Aptinyx Clinical Site | Orange | California |
United States | Aptinyx Clinical Site | Orlando | Florida |
United States | Aptinyx Clinical Site | Palmetto Bay | Florida |
United States | Aptinyx Clinical Site | Phoenix | Arizona |
United States | Aptinyx Clinical Site | Prairie Village | Kansas |
United States | Aptinyx Clinical Site | Redlands | California |
United States | Aptinyx Clinical Site | Roslindale | Massachusetts |
United States | Aptinyx Clinical Site | Skokie | Illinois |
United States | Aptinyx Clinical Site | Staten Island | New York |
United States | Aptinyx Clinical Site | Temecula | California |
United States | Aptinyx Clinical Site | Torrance | California |
United States | Aptinyx Clinical Site | West Des Moines | Iowa |
United States | Aptinyx Clinical Site | Wichita | Kansas |
United States | Aptinyx Clinical Site | Williamsville | New York |
United States | Aptinyx Clinical Site | Winter Park | Florida |
Lead Sponsor | Collaborator |
---|---|
Aptinyx | Worldwide Clinical Trials |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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) | Week 12 | |
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 | Week 12 | |
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. | Week 12 | |
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). | Week 12 | |
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) | Week 12 | |
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 | Week 12 | |
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. | Week 12 | |
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 | Week 12 | |
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. | Week 12 | |
Secondary | Use of Rescue Medication | The number of subjects using rescue medication. | Week 12 |
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