Trial record 1 of 5 for:
NYX-2925
Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia
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| ClinicalTrials.gov Identifier: NCT04147858 |
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Recruitment Status :
Recruiting
First Posted : November 1, 2019
Last Update Posted : October 5, 2021
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Sponsor:
Aptinyx
Collaborator:
Worldwide Clinical Trials
Information provided by (Responsible Party):
Aptinyx
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Brief Summary:
To evaluate the efficacy of NYX-2925 versus placebo for the treatment of fibromyalgia.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Fibromyalgia | Drug: NYX-2925 Drug: Placebo | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 300 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Masking Description: | Randomization algorithm, randomization allocation, allocation to study drug or placebo. |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia |
| Actual Study Start Date : | November 12, 2019 |
| Estimated Primary Completion Date : | June 2022 |
| Estimated Study Completion Date : | June 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Fibromyalgia
MedlinePlus related topics:
Fibromyalgia
| Arm | Intervention/treatment |
|---|---|
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Experimental: NYX-2925 50 mg
NYX-2925 50 mg administered orally.
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Drug: NYX-2925
NYX-2925 administered orally |
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Experimental: NYX-2925 100 mg
NYX-2925 100 mg administered orally.
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Drug: NYX-2925
NYX-2925 administered orally |
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Placebo Comparator: Placebo
Placebo administered orally.
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Drug: Placebo
Placebo administered orally |
Primary Outcome Measures :
- Change in the mean Numerical Rating Scale (NRS) score [ Time Frame: Week 12 ]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
Secondary Outcome Measures :
- Patient Global Impression of Change (PGI-C) [ Time Frame: Week 12 ]Percentage of subjects "much improved" or "very much improved" on the Patient Global Impression of Change (PGI-C) at Week 12
- Daily Sleep Interference (DSIS) score [ Time Frame: Week 12 ]Change from baseline in the weekly mean of the Daily Sleep Interference Scale (DSIS) scores at Week 12
- Percentage of subjects achieving ≥30% pain reduction [ Time Frame: Week 12 ]Percentage of subjects achieving ≥30% reduction from baseline in the weekly mean NRS average pain intensity at Week 12
- Percentage of subjects achieving ≥50% pain reduction [ Time Frame: Week 12 ]Percentage of subjects achieving ≥50% reduction from baseline in the weekly mean NRS average pain intensity at Week 12
- Fibromyalgia Impact Questionnaire-Revised (FIQR) score [ Time Frame: Week 12 ]Change from baseline to Week 12 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) score
- Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) sleep disturbance score [ Time Frame: Week 12 ]Change from baseline to Week 12 in the PROMIS-FM sleep disturbance score
- Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) fatigue profile score [ Time Frame: Week 12 ]Change from baseline to Week 12 in the PROMIS-FM fatigue profile score
- Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) physical function score [ Time Frame: Week 12 ]Change from baseline to Week 12 in the PROMIS-FM physical function score
- Cumulative response (percent reduction from baseline) in weekly mean NRS [ Time Frame: Week 12 ]Cumulative response (percent reduction from baseline) in the weekly mean NRS average pain intensity at Week 12
- Use of rescue medication [ Time Frame: Week 12 ]Use of rescue medication, including the proportion of subjects using rescue medication, the frequency and amount used
- Change in the mean NRS score at each week [ Time Frame: Week 1 - Week 12 ]Change from baseline in the weekly mean of the daily Numerical Rating Scale (NRS) at each week from Week 1 through Week 12
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04147858
Contacts
| Contact: Aptinyx Clinical Development | 847 871 0377 ext 1 | clinicalstudies@aptinyx.com |
Locations
| United States, Arizona | |
| Aptinyx Clinical Site | Recruiting |
| Phoenix, Arizona, United States, 85012 | |
| United States, California | |
| Aptinyx Clinical Site | Recruiting |
| Culver City, California, United States, 90230 | |
| Aptinyx Clinical Site | Recruiting |
| Fresno, California, United States, 93710 | |
| Aptinyx Clinical Site | Recruiting |
| Orange, California, United States, 92868 | |
| Aptinyx Clinical Site | Recruiting |
| Redlands, California, United States, 92374 | |
| Aptinyx Clinical Site | Recruiting |
| Temecula, California, United States, 92591 | |
| Aptinyx Clinical Site | Recruiting |
| Torrance, California, United States, 90502 | |
| United States, Florida | |
| Aptinyx Clinical Site | Recruiting |
| Coral Gables, Florida, United States, 33134 | |
| Aptinyx Clinical Site | Recruiting |
| Fernandina Beach, Florida, United States, 32034 | |
| Aptinyx Clinical Site | Recruiting |
| Jacksonville, Florida, United States, 32224 | |
| Aptinyx Clinical Site | Recruiting |
| Jacksonville, Florida, United States, 32256 | |
| Aptinyx Clinical Site | Recruiting |
| Lady Lake, Florida, United States, 32159 | |
| Aptinyx Clinical Site | Recruiting |
| Miami, Florida, United States, 33165 | |
| Contact: Aptinyx C Site | |
| Aptinyx Clinical Site | Recruiting |
| Orlando, Florida, United States, 32801 | |
| Aptinyx Clinical Site | Recruiting |
| Palmetto Bay, Florida, United States, 33157 | |
| Aptinyx Clinical Site | Recruiting |
| Winter Park, Florida, United States, 32789 | |
| United States, Georgia | |
| Aptinyx Clinical Site | Recruiting |
| Alpharetta, Georgia, United States, 30022 | |
| United States, Illinois | |
| Aptinyx Clinical Site | Recruiting |
| Chicago, Illinois, United States, 60607 | |
| Aptinyx Clinical Site | Recruiting |
| Flossmoor, Illinois, United States, 60422 | |
| Aptinyx Clinical Site | Recruiting |
| Gurnee, Illinois, United States, 60031 | |
| Aptinyx Clinical Site | Recruiting |
| Skokie, Illinois, United States, 60076 | |
| United States, Indiana | |
| Aptinyx Clinical Site | Recruiting |
| Evansville, Indiana, United States, 47714 | |
| United States, Iowa | |
| Aptinyx Clinical Site | Recruiting |
| West Des Moines, Iowa, United States, 50265 | |
| United States, Kansas | |
| Aptinyx Clinical Site | Recruiting |
| Newton, Kansas, United States, 67114 | |
| Aptinyx Clinical Site | Recruiting |
| Prairie Village, Kansas, United States, 66208 | |
| Aptinyx Clinical Site | Recruiting |
| Wichita, Kansas, United States, 67205 | |
| United States, Massachusetts | |
| Aptinyx Clinical Site | Recruiting |
| Roslindale, Massachusetts, United States, 02131 | |
| United States, Missouri | |
| Aptinyx Clinical Site | Recruiting |
| Hazelwood, Missouri, United States, 63042 | |
| United States, Nebraska | |
| Aptinyx Clinical Site | Recruiting |
| Omaha, Nebraska, United States, 68114 | |
| United States, Nevada | |
| Aptinyx Clinical Site | Recruiting |
| Las Vegas, Nevada, United States, 89102 | |
| United States, New York | |
| Aptinyx Clinical Site | Recruiting |
| Brooklyn, New York, United States, 11235 | |
| Aptinyx Clinical Site | Recruiting |
| New York, New York, United States, 10017 | |
| Aptinyx Clinical Site | Recruiting |
| New York, New York, United States, 10036 | |
| Aptinyx Clinical Site | Recruiting |
| Staten Island, New York, United States, 10312 | |
| Aptinyx Clinical Site | Recruiting |
| Williamsville, New York, United States, 14221 | |
| United States, North Carolina | |
| Aptinyx Clinical Site | Recruiting |
| High Point, North Carolina, United States, 27265 | |
| United States, Ohio | |
| Aptinyx Clinical Site | Recruiting |
| Cincinnati, Ohio, United States, 45219 | |
| United States, Oklahoma | |
| Aptinyx Clinical Site | Recruiting |
| Oklahoma City, Oklahoma, United States, 73106 | |
| United States, Pennsylvania | |
| Aptinyx Clinical Site | Recruiting |
| Duncansville, Pennsylvania, United States, 16635 | |
| United States, Tennessee | |
| Aptinyx Clinical Site | Recruiting |
| Memphis, Tennessee, United States, 38119 | |
| United States, Texas | |
| Aptinyx Clinical Site | Recruiting |
| Austin, Texas, United States, 78737 | |
| Aptinyx Clinical Site | Recruiting |
| Houston, Texas, United States, 77077 | |
| United States, Virginia | |
| Aptinyx Clinical Site | Recruiting |
| Danville, Virginia, United States, 24541 | |
| United States, Washington | |
| Aptinyx Clinical Site | Recruiting |
| Bellevue, Washington, United States, 98007 | |
Sponsors and Collaborators
Aptinyx
Worldwide Clinical Trials
| Responsible Party: | Aptinyx |
| ClinicalTrials.gov Identifier: | NCT04147858 |
| Other Study ID Numbers: |
NYX-2925-2005 |
| First Posted: | November 1, 2019 Key Record Dates |
| Last Update Posted: | October 5, 2021 |
| Last Verified: | October 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases |
Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |